On this day when Vaclav Havel passed away. In this post, I come out explicitly with an argument against the use of contraceptive pills and related agents (all Endocrine-Active Compounds [EACs]), because of the serious consequences of the sex steroid chemicals for women’s health. I start with evidence from Google statistics.

It is possible to examine the English-language literature for the frequency of addressing certain topics over a period of time. I already did this in the recent post “Seven billion people – after half a century with the Pill”.

Let’s look at data from Google Ngram Viewer about the statistics of the occurrence of certain topics (such as difficult birth) in all books published in English. The data is obtained via http://books.google.com/ngrams/info – for anyone to examine.

Briefly, when we enter phrases into the Google Books Ngram Viewer, it displays a graph showing how frequently those phrases occurred in a corpus of books (here English-language books) over the selected years (here 1900 to 2000). The data is normalized by the number of books published in each year.

Here we have a comparison of statistics of three phrases:

pregnancy complications (blue),

difficult birth (red), and

trying to conceive (green).

Ngram 6: pregnancy complications, difficult birth, trying to conceive

The topic of difficult birth exhibits an almost linear growth over the century, even though there are discernible steps in the early years such as the step that followed the plateau (flat portion) lasting from about 1915 to just before 1930, when it “shoots up to catch up with” the overall trend. And, overall, the red curve grows steadily from 1900 to 2000.

In contrast, the blue curve of pregnancy complications and the green curve of trying-to-conceive both shoot up only after 1960, the decade of the introduction of the contraceptive pill. The steep rise in pregnancy complications books (blue) starts soon after 1960. The rise in the number of books about trying-to-conceive (green) starts in mid-1970s and is also distinctly faster than the steady growth over the century of books on difficult birth (red), although it is slower than the pregnancy complications that started going up some ten years earlier.

Of course, the green trying-to-conceive curve is not uninteresting in the early decades of the century, either, if only because it appears that the late Victorians had a significant interest in the topic, much higher than in the other two and especially as compared to pregnancy complications (blue). I’ll leave any discussion of the trend there to others, although the downward trend in the first half of the century would seem consistent with the rise of the birth control movement and with the consequences of two World Wars, and the Great Depression in between.

Peter Paul Rubens, Allegory of War, c. 1628

Those two generations had it tough but, on the other hand, their health, the health of humankind, was not yet assaulted by the sex-steroid chemicals that were introduced in the 1960s.

In a previous bioZhena’s Weblog post, you can see evidence that oral contraceptive use directly and negatively impacts the cervical crypts, which brings about the difficulty to conceive. The bottom line is this: “After 3 and up to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced.” The S crypts are needed for conception.

To further cite Professor Erik Odeblad: “Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural estrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced. Treatment is difficult.”

This is a serious problem because, according to medical literature, most American women, “approximately 85% of U.S. women will use the OC (oral contraception) for an average of five years.¹ However, women’s OC use, similar to other chronic medications, is often inconsistent and transient.² Reported six-month OC discontinuation rates vary from 18% to 50%.^3,4,5 Unintended pregnancy often follows OC discontinuation” END OF QUOTE. (Am J Obstet Gynecol. 2007 April; 196(4): 412.e1–412.e7)

These data can be read and understood as the double-whammy put on or dealt to American reproductive and public health. That is the high prevalence of trying-to-conceive problems (sub-fertility and infertility) and at the same time the very high rate of unintended pregnancies.

Lion_Hunt_Mosaic in Pella

zb.jpg

While many proponents of chemical contraception minimize or gloss over the side effects of contraceptive chemicals, it is known that “OCPs (oral contraceptive pills) have several known metabolic effects including increased production of clotting factors resulting in increased risk of venous thromboembolism, increased gallstone formation during the first year of use, and increased risk of liver adenomas (Speroff and DeCherney 1993)” – cited from Ther Clin Risk Manag. 2008 October; 4(5): 905–911 (paper from University of Vermont College of Medicine and Reproductive Endocrinology and Infertility, Women’s Health Care Services)

That said, studies mainly focus on side effects such as amenorrhea, the incidence of breakthrough bleeding and spotting, compliance, discontinuation rates or patient satisfaction, headaches, genital irritation, tiredness, bloating, and menstrual pain.

To cite from said medical publication “Evaluation of extended and continuous use oral contraceptives”, Ther Clin Risk Manag. 2008 October; 4(5): 905–911 QUOTE [emphasis mine]:

In a normally menstruating woman who is not taking contraceptive hormones, progesterone is only present in appreciable quantities during the luteal phase of the menstrual cycle [meaning: after ovulation], after the development of the endometrium. When combination OCPs are administered, the effect of the progestational agent takes precedence over the estrogen component in the reproductive tract, and the endometrium demonstrates this progestin effect (Moyer and Felix 1998). The result is a thin, decidualized (transformed) endometrium with atrophied glands that is not receptive to embryo implantation. Progestins also cause thick, impermeable cervical mucus, preventing sperm from reaching the uterine cavity, and also decrease tubal mobility, altering the movement of sperm and oocytes through the fallopian tube (Johnson et al 2007; Rossmanith et al 1997) END OF QUOTE.

This is consistent with the Erik Odeblad findings about the fine structure of the cervical tissues. http://humrep.oxfordjournals.org/cgi/content/full/18/9/1782

Edward_Burne-Jones_Maria_Zambaco_1870

Further to the examples of studies about the mainly short-term effects of chemical contraception, here are examples of published findings about the harmful long-term effects of the sex steroid chemicals administered to healthy women. This is not a systematic review, merely a couple of examples.

BONE HEALTH:

The conclusion of “Effects of Depot Medroxyprogesterone Acetate and 20 μg Oral Contraceptives on Bone Mineral Density” [Obstet Gynecol. 2008 October; 112(4): 788–799]is as follows:

QUOTE Use of very low-dose OCP (Oral Contraceptive Pill) may result in a small amount of bone loss. DMPA (depot medroxyprogesterone acetate) use results in greater bone loss, but this is largely reversible at the spine. Use of very low-dose OCPs after DMPA discontinuation may slow bone recovery.

As a result, the Food and Drug Administration issued a warning in 2004 advising women to limit its use to ≤2 years.

Oral contraception (OC) containing only 20 μg ethinyl estradiol (EE) may also adversely affect bone health, especially if used during adolescence. END OF QUOTE [emphasis mine].

HEART HEALTH:

According to J Clin Endocrinol Metab. Author manuscript; available in PMC 2011 November 9 (Published in final edited form as: J Clin Endocrinol Metab. 2007 August; 92(8): 3089–3094), “whether OCP use in healthy young women is associated with increased CV (cardiovascular) risk is controversial. However, a recent meta-analysis of 14 studies showed that current use of low-dose OCPs increased the risk for myocardial infarction by 84% (37). More data are available regarding CV risk associated with estrogen/progestin use in older women… The Heart and Estrogen/Progestin Replacement Study showed an early increase in events and no benefit overall in women with known CV disease, and the Women’s Health Initiative (WHI) trial demonstrated an increase in CV events in healthy women (38, 39).” END QUOTE.

René Boyvin, The rape of Europa, c. 1545-55

In Greek mythology Europa (Greek Ευρώπη Eurṓpē) was… seduced by the god Zeus in the form of a bull, who breathed from his mouth a saffron crocus^[14] and carried her away to Crete on his back… and so see Wikipedia for the whole story.

Max Beckmann, The rape of Europa (1933)

Returning to Odeblad’s results on the consequences of the Pill for the cervix uteri, that is on how contraceptive chemicals make it difficult to conceive later – and reiterating the take-home message put forward previously in “About atrophy, reproductive aging, and how it’s really not nice to fool Mother Nature – or with”:

Natural aging of cervical S crypts (= cervical aging of a woman never pregnant and never on the Pill):

S crypts, which are needed for conception, are down to 20% at 40 years of age, at the natural aging rate -2% per year. Here you have the reason why a too mature age leads to sub-fertility and to infertility. My remark: The optimal age for motherhood has always been and always will be the early twenties of a woman’s life.

Atrophy acceleration effect of 10 years on the Pill:

S crypts are down to mere 10% at 40 years of age. Here is why it’s not nice to fool Mother Nature, why it’s not good to mess with her design. Fertility is drastically reduced. The Pill is an archetypal anthropogenic Endocrine-Active Compound [man-made EAC]. It was brought up previously in this blog how there are very many of these EACs, all insulting the female body and health; some – like chemical contraceptives – by design. Having invoked the design, I am reminded that the original designers of the Pill had no idea about contraception – they were pushing the frontiers of steroid chemistry… (not this particular application of one kind of steroids).

Atrophy slow-down or beneficial effect of pregnancies:

S crypts only down to 40% at 40 years of age. Here you see Mother Nature’s design in action. Pregnancy slows down the inherent rate of natural cervical aging (atrophy, deterioration). The effect of 4 pregnancies was measured in the Odeblad research. This is not to argue for 4 pregnancies per lifetime – it’s merely how the difference between with and without was made more “easily” measurable in the very difficult studies.

And again, the bottom line is this: “After 3 and up to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced. …S crypts are very sensitive to normal and cyclical stimulation by natural estrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced.” END QUOTE.

In case you’d like to view the Carlo Adelio Galimberti picture accompanying the concluding words, please re-visit the cited earlier post. The concluding words were and still would be: While the story of Laodamia and Protesilao is touching, I merely want to ask that girls, ladies and their physicians do not moon the messenger.

P. S.

Vaclav Havel would smile at the image of “mooning” Laodamia. I smile at the thought of his riding the children’s scooter (kolobezka) along Saint Peter’s heavenly corridors (looking for Olga? Since Pani Dagmar remained down there?). He reportedly did that scooter-running in the “labyrinthine” corridors of Prague Castle…

Filed under: 1, blog, fertility, reproductive-health, women's-health Tagged: cervix, contraception, infertility, Pill, side effects ]]> http://biozhena.wordpress.com/2011/12/18/difficult-to-conceive-google-evidence-that-pregnancy-complications-and-trying-to-conceive-concerns-shot-up-after-the-pill-launch-in-1960s/feed/ 0 biozhena Ngram 6: pregnancy complications, difficult birth, trying to conceive Peter Paul Rubens (1577-1640), Allegory of War, c. 1628 http://en.wikipedia.org/wiki/Pella zb.jpg Edward_Burne-Jones_Maria_Zambaco_1870 René Boyvin, The rape of Europa, c. 1545-55 Max Beckmann, The rape of Europa (1933) http://biozhena.wordpress.com/2011/11/30/much-in-womens-health-revolves-around-folliculogenesis-from-teen-age-to-peri-menopause/ http://biozhena.wordpress.com/2011/11/30/much-in-womens-health-revolves-around-folliculogenesis-from-teen-age-to-peri-menopause/#comments Thu, 01 Dec 2011 05:43:32 +0000 biozhena http://biozhena.wordpress.com/?p=1595 ]]> In this article I sketch for you the usefulness of the Ovulona™ Smart Sensor™ throughout a woman’s life, with particular attention paid to the extremes of the reproductive lifespan.

We outline the significance of the cervical tissue biosensor for a woman’s health management from adolescence (the teen years) to peri-menopause. This schematic diagram is a pictorial synopsis of the multi-purpose utility of the Ovulona throughout most of a woman’s lifetime.

As you recall from prior posts on this blog, FIV™ stands for FOLLICULOGENESIS IN VIVO™, which translates as the sequence of menstrual cyclic records that will be captured and stored (automatically saved) in the Ovulona during normal use by a woman at home. The data is available for transfer to healthcare providers’ Ovulograph™ for medical uses during the reproductive years.

The reproductive age is officially defined as 14 to 44 but we’d encourage, for health reasons, to chop off a few years at both ends from the actual reproductive (high end) or sex-exploration activities (low end). When folliculogenesis – i.e. menstrual cycling – ceases in menopause, hormone therapy and cervical tissue health screening are the two components of menopause and post-menopause health management, to which the Ovulona is applicable.

In this article, I address very briefly (tweetingly!) the two “boundary conditions” of said reproductive years.

I’ll deal with the young boundary condition, i.e. adolescence or teen age, in the style popular nowadays especially at that stage of life . That is, I let speak a few tweets, mostly from http://topsy.com/biozhena.wordpress.com/2009/03/12/far-more-than-a-tool-for-reproductive-management/ .

When you look at the tweetingly referenced papers (click the short URLs below), you will see how the teen cramp sufferer needs our Ovulona. That’s because she must take the anti-inflammatory medication before the ovulation-linked pain hits, otherwise the med would not work. She – or is it you? – must be able to anticipate ovulation. You need the Ovulona. The timing is crucial, similar to the right timing for conception purposes… (Recommended reading: http://endometriosis.org/treatments/painkillers/ = http://to.ly/6ZsS in the #NSAIDs tweet below).

If it’s menstrual bleeding (not ovulation) that pains you, the Ovulona will tell you when you expect that – whether it is ovulation + 14 days or, probably more likely at this young age, ovulation + irregular. You’ll then see on the display your recorded min and max, with respective probabilities the more accurate the longer you’ve used the Ovulona. That’s this app’s meaning of Smart Sensor™ for you! (And that is because we don’t track just this or that hormone in your pee! Or your BBT, or your signs…)

As for the STD screening aspect of those young years, indicated in the pictorial synopsis above, I refer you to the recent posts in this blog; and the sex ed use of the Ovulona – or rather its recorded data and their discussions in classes – is self-explanatory.

But then there is the subject of chemical contraception, the Pill. So, here, a couple of tweets from http://topsy.com/biozhena.wordpress.com/2010/06/27/about-atrophy-reproductive-aging-and-how-it’s-really-not-nice-to-fool-mother-nature–or-with/?utm_source=topsy_module

A teenage girl has a #dilemma With the #Pill she brings on herself a significantly earlier #menopause & likely difficulty to #conceive http://to.ly/5f2W

#Menstrual #cramps are bad but don’t allow them – by taking the #Pill – to cause you the much worse #pain of #TTC #infertility http://to.ly/5f2W    [TTC = Trying To Conceive. That’s the phrase and acronym used by people who have difficulty getting pregnant.]

http://to.ly/5f2W Even with just 3-15 months of contraceptive #pill use you suffer greater loss of S crypt cells than can be replaced. Then hard #TTC is likely   [S crypts are part of the microscopic structure of the cervical epithelium, of the tissues.]

Here now are those few tweets referring to dysmenorrhea, the menstrual pain which causes so much suffering and so many lost hours at school and/or at work. In this day and age!

#NSAIDs against #endometriosis pain http://to.ly/6ZsS Since you must take the meds BEFORE expected #cramps you need our Ovulona tool to anticipate ovulation http://to.ly/MJS [NSAIDs = Non-Steroidal Anti-Inflammatory Drugs]

@bioZhena/fertility    http://to.ly/MJS Why most girls get cramps What goes on there Why & what’s PCOS See it with Ovulona [Obese girls tend to grow into women with PCOS = Poly Cystic Ovary Syndrome, the cause of major killer diseases, and often causing infertility.]

Folliculogenesis #InVivo for Why Do Most Girls Suffer With #dysmenorrhea #cramps http://to.ly/MJS #womenshealth #diagnostic #medicaldevice

Ovulona for etiology & management of  #dysmenorrhea Why do teen girls suffer with #cramps? http://to.ly/MJS #pharma #medtech #medicaldevice [etiology = the cause or origin of a disease]

Re: etiology of adolescent #dysmenorrhea Prostaglandin theory & treatment known since the 1980s Why are period cramps still so bad?

I leave you and this “boundary condition for Ovulona’s use” with two Google Insights graphs. Look here how the worldwide interest level in the subject of period cramps has been increasing since 2004.

Period cramps worldwide searches from 2004 by Google Insights

Don’t ask me why the recorded public interest is emanating from those particular English-speaking countries and not from numerous others, and look for details at http://www.google.com/insights/search/#cat=0-45&q=period%20cramps&cmpt=q (you can change the selected parameters and observe the effect of the changes).

I merely note the periodicity developing in the data in recent years on top of the clear upward trend, the periodicity indicative of highest interest in summertime (such as in July 2011)…

This is, of course, the same in the next graph, where I added dysmenorrhea (red) for comparison. That’s a difficult word, so it is not as much searched on as the colloquial cramps – except for, if you look closely, in (Southeast)Asia.

Blue: period cramps Red: dysmenorrhea Web Search Interest: period cramps, dysmenorrhea Worldwide, 2004 - present

I’ll now use one more tweet to segue into the other end of the span of reproductive years.

#estrogen can be a good medication but we need #personalizedmedicine tools We must measure & titrate #hormone uptake http://t.co/CeCsWgn

The following illustration shows that we at bioZhena have the technology with which to do that, i.e. a tool with which to adjust treatment to suit a given female patient.

The illustration is a graph of the effects of estrogen and progesterone monitored with our technology in an ovariectomized pig. Ovariectomy is the removal of the ovaries. It is the animal equivalent of surgical hysterectomy, which causes surgical menopause since the reproductive system no longer produces said sex hormones, the sex steroids estrogen and progesterone.

In the illustrated experiment, the steroids were later given to the animal (after recovery from surgery), and the result was that progesterone drove the sensor signal down versus estrogen drove it up (as seen in FIG. 5 below, excerpted from our patent portfolio). This is a useful finding, for example for monitoring the effects of hormone replacement therapy (HRT). 

Graph of estrogen and progestagen effects on porcine cervix

We also have the proof of the concept generated by a menopausal woman, using a Premarin treatment in that experiment (Premarin is an estrogen medication used for treating the symptoms of menopause including hot flashes, vaginal dryness, etc.). The data was used in another patent in our portfolio.

Experts advocate that women in their 30s and 40s should look at menopause now. Health maintenance depends on diagnostic tools. We propose that the preparation for menopause be done – in a simple quick daily routine - by systematically monitoring the Ovulona menstrual cyclic profile, and how it changes over the years. How it responds to pregnancy and birth, to things like diet, exercise, various ills, various medications, stress… in the particular woman user, not some statistical average. For evidence-based personalized health care.

That’s the broader meaning and the purpose of the folliculogenesis cyclic profile generated by the Ovulona. It’s not merely (“merely”!) for helping to get pregnant or for avoiding pregnancy without chemicals, as is illustrated and described in “Pregnancy and birth control how-to by bioZhena” at this Photobucket site. In the third graphic, at this page, see the follicular waves that relate to follicular age, i.e. how fast is menopause approaching, after pregnancies were successfully achieved and then regulated in this Ovulona-guided manner.

This is because the cervix monitors the physiological inputs after conception and after pregnancy just like it does the monitoring before fertilization and before birth. We pick up the diagnostically useful information from this key female organ. We speak of end organ effects.

For a still broader perspective, including symptometric monitoring correlated with folliculogenesis, go to “Far more than a tool for reproductive management”.

STOP PRESS

In case you are interested in our Ovulona Fertility Monitor/Smart Sensor, let me suggest that you look into a proposition whereby you can secure a substantial discount on your future Ovulona by promising to prepay at least a portion of it. Since the project has set a goal period of 90 days, the proposition will not stay open longer than after the Valentine’s Day (90 days from December 1, 2011). Do check it out, and see that it is a win – win, at  http://www.fundageek.com/Project/Detail/237  . 

Eyeball the “infographic” data below here, accepting that the image contains one of the small European languages. You can handle this because it is a graphic representation of the world and its population. The data is based on a United Nations Report about the State of the World Population. I did not find anything like this infographic when I googled for said UN report, and the bigger languages of Europe were presumably preoccupied by other concerns (like the economy, and the associated politics, stupid…).

So, we refer to this source with all those un-English letters with diacritical marks [RB, Lidové noviny. From: http://www.lidovky.cz/je-nas-7-miliard-lidstvo-v-budoucnu-uzivi-jen-zemedelska-revoluce-phq-/ln_zahranici.asp?c=A111031_085513_firmy-trhy_mev ]. It’s the numbers and symbols that matter, including the relative sizes of the circles. And note also that the blue circles represent the size of the respective continents’ populations in 2010 versus the red projected population sizes in the year 2050.

By 2050, only Europe’s population will have decreased (projected by 19 million), while all the other continents’ populations will have continued to grow. North America’s population, by the way, is projected to grow only due to immigration, otherwise it would be dropping, too. At least the USA’s would.

World population

http://www.lidovky.cz/foto.asp?foto1=MEV3ed992_2poulaceTTTa.png

12 years times 365 days/year = 4,380 days

Population growth = 1,000,000,000 people / 4,380 days =  228,310.5 people born per day  (2,511,415.5 babies in 11 days = 1 billion divided by 4,380 days in 12 years times 11 days)

Check out the arithmetic of the global population growth in recent days, if you like. It is based on the birth rate of 1 billion births per 12 years. That is indicated in the bottom part of the infographic, showing the worldwide number of people in increasing billions against the years at which the given billion count was reached up to now, and is projected to be reached in the future [rok means year and pocet obyvatel means number of people]. It’s noticeable that the UN-projected future growth rate slows down: see how 16, 29, 27 years between additional billion increments are projected for the next 3 one-billion increments.

I won’t go into the (serious) economic and political consequences of these numbers. Rather, I ask you to note that the current birth rate (1 billion per 12 years) has held steady for the last 3 or 4 one-billion increases in world population. Over the last half a century, world population grew in steps of one billion per 12 years

In other words, the introduction of chemical contraception in the 1960s has NOT slowed down the global population growth. Unless you say that 12, 12, 12 is better than, say, 12, 6, 3, which is true, too.

We see that reaching the first billion of humans took about 18 centuries. The second billion then took 123 years and the third 33 years, both these surely influenced by the two world wars. After that, the Pill notwithstanding, almost a quarter of a million new people have been and are born globally every day (1B / 4,380 days of 12 years = 228,310.5 births per day).

Evidently, the introduction of the oral contraceptive pills and related contraceptives has NOT stopped the global population explosion. But then, what about the United Nations-projected drop in the population of Europe (which is a continent where the Pill is surely available)?

Well, I propose to share with you some data from Google Ngram Viewer, about the stats on the recent historical occurrence of certain topics (such as contraception) in all books published in English, the data obtained via http://books.google.com/ngrams/info .

Briefly, when you enter phrases into the Google Books Ngram Viewer, it displays a graph showing how those phrases have occurred in a corpus of books (here English-language books) over the selected years (here 1900 to 2008).

And an important point, also cited from there.

Question: Many more books are published in modern years. Doesn’t this skew the results?

Answer: It would if we didn’t normalize by the number of books published in each year.

Here is an example of the occurrence of three phrases (topics) in English-language books over the century from 1900 till 2008, the latest year available. The topics are: pregnancy complications, difficult birth, and birth complications.

Ngram 1: pregnancy complications, difficult birth, birth complications

http://books.google.com/ngrams/graph?content=pregnancy+complications%2Cdifficult+birth%2Cbirth+complications&year_start=1900&year_end=2008&corpus=0&smoothing=5

The N numbers (or the number of phrase occurrences relative to all books) for the three topics are on the same scale as indicated on the vertical axis, and the graph shows that the number of books on difficult birth (red curve) rose steadily over the century – but the books on pregnancy complications (blue curve) and birth complications (green curve) shot up after 1960. These N numbers eventually level off and/or begin to decline after the year 2000. (As though everything has been written up, nothing new to publish?)

There were many more books written about birth control over the same period of 108 years. We can detect this in the N count on the vertical axis, which here has only 3 leading zeros as opposed to the 5 leading zeros at the maximum level in the previous graph (a hundred times as many books, even in 2008, after the decline from the mid-1970s). The initial rise from 1910 to 1930 must have been not on chemical contraception but (mostly) on the then happening calendar method of Ogino and Knaus, i.e. the later discarded so-called “Vatican Roulette”. That approach to birth control did not work – it could not work – so Margaret Sanger took it on herself (and on her wealthy-widow friend, Katharine McCormick) to cause the “magic bullet” of a pill to be developed. Some magic!

Ngram 2: birth control

http://books.google.com/ngrams/graph?content=birth+control&year_start=1900&year_end=2008&corpus=0&smoothing=3

One more Ngram Viewer graph, since they say that three is a charm! The following graph compares the number of books on infertility (blue) with the number of books on contraception (red), and it is on the same scale as the birth control graph above (with only slightly lower maximum level, 0.00035% here vs. 0.00045% above).

Ngram 3: infertility and contraception

http://books.google.com/ngrams/graph?content=infertility%2Ccontraception&year_start=1900&year_end=2008&corpus=0&smoothing=3

Three may be a charm, but I will show you one more, so that you (or your friendly gynecologist) will not accuse me of trying to show that chemical contraception has caused infertility (the infertility epidemic). I have merely shared Google’s Ngram Viewer statistics on books written on given topics. Discourses written on contraception preceded those on infertility by at least 10 years, and the number of infertility books was still rising when contraceptive books were already declining in numbers in the 1980s.

Here then is one more Ngram comparing N numbers of books on behavior problems (blue), mental problems (red), and books on birthing (green curve).

Ngram 4: behavior problems, mental problems, birthing

http://books.google.com/ngrams/graph?content=behavior+problems%2Cmental+problems%2C+birthing&year_start=1900&year_end=2008&corpus=0&smoothing=3

You see that there are four leading zeros in the scale on the vertical axis, so the order of magnitude of the graphed N numbers is between the two orders of magnitude discussed above (it’s an order of magnitude below infertility and contraception). All three of the numbers in this Ngram rise around 1970, behavior problems books before, birthing books after.

Why did the numbers of books on birthing rise so sharply some 15 years after 1960? I don’t know that there is such a thing as invalid questions. The curves for mental health and birth are correlated, rising around 1970, too (not shown here).

Chemical contraception has not worked to reverse the global population explosive growth.

But look at the last Ngram, below, which compares the number of books on birth control (blue), sexually transmitted diseases (red), STD (green), VD (yellow), and STDs (dark blue). It is on the same scale as the birth control graph above (the second in the series). The green spike after 1960 is STD in singular, as opposed to sexually transmitted diseases (red) and STDs (dark blue), which you see rising slowly after 1980, paralleled by the higher green curve in those years, which starts going up even earlier.

This can be rationalized by the fact that earlier on there was merely one STD (or two), called VD in Britain and in Europe (yellow curve), where the rise occurred somewhat later than in the U.S., along with the slight delay in the “sexual revolution” and its consequences or rather the concerns about those consequences. The broad green, red and dark blue hills of elevated N readings before year 2000 reflect the multitude of STDs today, which numbers did not exist before the sexual revolution. The singular VD has morphed into the plural STDs and sexually transmitted diseases.

Ngram 5: birth control, sexually transmitted diseases, STD, VD, STDs

http://books.google.com/ngrams/graph?content=birth+control%2Csexually+transmitted+diseases%2CSTD%2CVD%2CSTDs&year_start=1900&year_end=2008&corpus=0&smoothing=3

I leave the “now what” maybe for another time, but a follower of this blog will have an idea, based on the earlier posts.

As of this writing, to cite the three bioZhena’s Weblog Top Posts (the past week):

Trying to conceive, #ttc, or the frustration of sub-fertility & infertility in 2010/2011          40 views

Saint Nicholas Day, his legend, and our modern day’s prematurity, EDD calculation, gestational age, problem with LMP          33 views

Critique of birth control efficacies in NFP as published by Marquette University researchers          21 views

I will tell you why screening for this sexually transmitted infection (STI) is much needed, if you promise that you will not shoot the messenger. Exaggerating? Not really, if or when you realize that chances are that you yourself are already infected.

I say that because “current evidence suggests that at least 50 percent of sexually active women have been infected with one or more types of HPV”. Most people with HPV have no symptoms. When the infection is present, symptoms may or may not include genital warts.

HPV stands for Human Papilloma Virus. That is the virus that causes cervical cancer, and goes slowly about it, which is both good and bad. Good because the disease can be treated before it kills, and bad because it may take so long before it raises its ugly head that it can come completely unexpected in the mature middle age and even later. That is why vigilance (meaning, screening for it) throughout one’s lifetime is well worth it – unless you are a fatalist.

Collage of drevoryt woodcuts Dekameron, Ceský dekameron, Bakchanálie by Zdenek Mézl 1980 Links: http://www.ikup.cz/item.php?id=600279&lan=EN http://www.galerieart.cz/mezl_cesky_dekameron_I.JPG http://www.galerieart.cz/prodej_mezl_staroveke_baje.htm

“Furthermore, the potential risk of infection from non-penetrative sexual contact remains undetermined, including the possible association between oral-penile contact and oral HPV, which is associated with oral cancer.” You can read this online in the peer-reviewed scientific publication Am. J. Epidemiol. (2003) 157(3): 218-226. The experts give a reference (ref. 3) for the 50%+ statistic, and elsewhere the Medical Institute for Sexual Health writes http://www.medinstitute.org/public/92.cfm  : “About half of all sexually active 18- to 22-year-old women are infected with it (ref. 10 = J Infect Dis. 2001;183(11):1554-1564)”.

Either way, let’s watch out for the killer disease, which fortunately is curable – if caught early. If not caught early (that is, if not detected, diagnosed and treated), The Ravisher wins.

Cervical cancer causes about the same number of deaths as HIV/AIDS every year [two references for this statement are cited in the above Medical Institute article http://www.medinstitute.org/public/92.cfm ].

Young Woman Attacked By Death (or The Ravisher) - Albrecht Durer

Get this: The human papilloma virus (HPV) is the most common sexually transmitted infection (STI) in the world, and it is the most important cause of cervical cancer, a major killer of women worldwide (the second biggest).

Another horrible statistic is that, according to a CDC study, one in four (26 percent) young women, girls between the ages of 14 and 19 in the United States – or 3.2 million teenage girls – are now infected with at least one of the most common sexually transmitted diseases. Those are human papillomavirus (HPV), chlamydia, herpes simplex virus, and trichomoniasis. See http://www.sciencedaily.com/releases/2008/03/080312084645.htm .

A bad news for the mature women, who are past their best years for birthing, is this: “Cervical cancer is the second leading cause of cancer deaths among women worldwide. Human papillomavirus (HPV) has been shown to be the precursor of cervical cancer in over 99% of the cases. … Although women aged 40 and above are not specifically considered high risk for HPV infection, many women are testing positive in this age group and are facing the impact of an HPV diagnosis that implicates a sexually transmitted disease and is known to be a precursor to cervical cancer.” So is written in J Am Acad Nurse Pract. 2010 Feb; 22(2):92-100, in a paper titled “The human papillomavirus in women over 40: implications for practice and recommendations for screening”.

Arnold Böcklin, The Plague, 1898

While the Pap smear diagnostic screening has significantly improved the situation over the many years since its introduction (first published by the inventor, Dr. Georgios Nicholas Papanikolaou late in the decade of “the swinging 1920s” but only recognized in the 1940s), at least 12,000 women are diagnosed with cervical cancer each year in the United States, accounting for at least 4,000 deaths. Statistics cited from J Sch Nurs. 2007 Dec; 23(6):310-4.

As commented in June 2011 at http://to.ly/aCD3 , #Cervical #cancer “smear tests are invasive, uncomfortable, embarrassing, and often are badly diagnosed. Another reader concluded: “De-stigmatize cervical  cancer and do some work to make the test less unpleasant – more #women will go” (will go to get the expensive test at a clinic, hoping for a negative result – and for not getting an unexpected huge bill, whether insured or uninsured in the U.S.).

Additional to the advantage of an objective electronic test over the subjective evaluation of a Pap smear: Is there a better way to avoid stigmatization than testing for cervical health in the privacy of one’s home, and in so doing making the test incomparably less off-putting, painless and perfectly affordable for anyone?

Similar to what the Pap smear can do, our tissue biosensing technique should detect the pre-cancerous tissue aberration called squamous intraepithelial lesion (SIL) or dysplasia, which is the earliest form of pre-cancerous lesion recognizable by a pathologist. Refer to http://en.wikipedia.org/wiki/Carcinoma_in_situ . Unlike the pathologist’s subjective assessment of the Pap smear sample, our in vivo monitoring method provides for an objective electronic evaluation.

In countries like India, the cervical cancer prevalence statistics are much worse, an order of magnitude higher. A big problem is that, among the general population, “knowledge about the relationship of HPV to cervical cancer is low even in the United States and the United Kingdom”. [Rapose A., Human papillomavirus and genital cancer. Indian J Dermatol Venereol Leprol 2009;75:236-44.] So therefore, we are trying to do something about that.

There are two main reasons why screening for cervical cancer is and will continue to be necessary. One is that the recently introduced HPV vaccines are far from perfect, and they explicitly require continued screening. Even the most expert proponents of HPV vaccination, and not just the vaccine manufacturers, say and write that.

Antonín Procházka, Milenci s knihou, litografie/lithograph, 1941

Then there is the other reason for the necessity of continued cervical cancer vigilance. It is that, contrary to the oft trumpeted exclamations, the classic “invention of a certain doctor Condom” does not make for safe sex, because it (the condom) only reduces, and certainly does not eliminate, not only the chances of becoming pregnant but also the chances of contracting a sexually transmitted infection. These are medico-scientifically proven facts.

The condom and similar barriers do not completely and reliably eliminate the chances of pregnancy if you happen to have sex during the mere three fertile days of your menstrual cycle (when you are outside of the fertile window, pregnancy simply cannot occur). And, condoms and similar barriers do not completely eliminate – they only reduce – the chances of contracting sexually transmitted infections including HPV.

For sources of this statement of fact, see for example the already referenced http://www.medinstitute.org/public/92.cfm : “Each year, there are about 19 million new infections; half of these are in people under 25 (ref. 2). Many of these STIs have no cure. Untreated STIs can cause infertility, cancer and even death.” In that article is also where you see the references for the statements that “If you use condoms every time you have vaginal sex, you can cut your chance of getting HPV by up to half (references 6,7,8,9)… In women, cervical cancer causes about the same number of deaths as HIV/AIDS every year (refs. 12,13).”

Note this: Evidence shows that HPV is contracted if sex is had at too early an age and/or if sex is had promiscuously as a one night stand entertainment, or even too early into a relationship.

The cervix is particularly vulnerable to infection between the first menstruation and the age of sixteen because there are still many undifferentiated cells at the surface of the cervix, which is therefore  susceptible to HPV infection [http://www.mendeley.com/research/early-first-intercourse-risk-factor-cervical-cancer/]. As cancer is a disease of failure of regulation of tissue growth, HPV causes these cells to transform into cancer cells by altering the genes which regulate cell growth and differentiation.

Edgar Degas - Young Spartans Exercising, circa 1860

An interesting story associated with the Degas painting includes “that the work could encompass a variety of meanings”, and that the fully dressed onlookers in the background are the youths’ mothers with Lycurgus, the legendary lawgiver of Sparta, who established the military-oriented reformation of Spartan society in accordance with the Oracle of Apollo at Delphi.

This blog post is not some exercise in moralizing. I am merely reporting or reflecting on medico-scientific findings. The above-referenced epidemiologists, Winer et al. [Am J Epidemiol 2003;157:218-26], evaluated young college women in Washington State and found that the risk factors for acquiring a new HPV infection included:

• sex with a new person in the previous 5-8 months,
• smoking, and
• use of oral contraceptives.
• Always using condoms did not provide protection according to this study.

The experts concluded that “in this population of female university students, the risk of infection associated with new partner acquisition is independent of prior sexual experience”, and that a “…finding suggests that an increased risk of incident HPV infection is more strongly associated with sex with a new partner than with sex with ongoing partners.” Thus written.

Peter Paul Rubens - The Union of Earth and Water, c. 1618 For the sake of appropriate symbolism, her name should be Aphrodite or Venus, of course, the promiscuous goddess of love, beauty and sexuality!

The authors wrote (and here we cite selected notions to reinforce the mentioned ones).

QUOTE:

• We detected a significant association between current smoking and incident HPV infection…
• We also observed a significant association between current oral contraceptive use and incident HPV infection.
• Having known a new partner for less than 8 months before vaginal intercourse was associated with an increased risk of HPV infection.
• Reporting a new sex partner who has had one or more or an unknown number of prior female sex partners was also a significant predictor of incident HPV infection.
• [Data] seems to suggest that the better and longer a woman knows her partner before intercourse, the less her risk of becoming infected with HPV.
• Consistent with previous studies (4, 7, 11, 17, 29, 30), we observed no protective effect associated with condom use. … Since HPV is transmitted presumably through skin-to-skin contact, condoms may not protect against HPV because the virus can be transmitted through non-penetrative sexual contact.
• Although vaginal intercourse is clearly the predominant mode of genital HPV transmission … any type of non-penetrative sexual contact was associated with an increased risk of HPV infection in virgins.
• At 24 months, the cumulative incidence of first-time infection was 32.3%… [FYI: That’s 32% of the 603 young women studied between September 1990 and September 1997 by interview and a standardized pelvic examination every 4 months, including HPV DNA analysis from separate cervical and vulvovaginal swab specimens.]
• Smoking, oral contraceptive use, and report of a new male sex partner –in particular, one known for less than 8 months before sex occurred or one reporting other partners– were predictive of incident infection. Always using male condoms with a new partner was not protective.
• The data show that the incidence of HPV associated with acquisition of a new sex partner is high and that non-penetrative sexual contact is a plausible route of transmission in virgins.
• HPV infections are highly prevalent, and current evidence suggests that at least 50 percent of sexually active women have been infected with one or more types (3).

In conclusion, the present study showed that the incidence of genital HPV associated with acquisition of a new sex partner is high, and that risk of infection is especially high if a partner has been known for less than 8 months and if a partner reports having had sex with other partners.

END OF QUOTES

[from Winer et al., that's Rachel L. Winer, Shu-Kuang Lee, James P. Hughes, Diane E. Adam, Nancy B. Kiviat and Laura A. Koutsky, in Am J Epidemiol 2003;157:218-26, "Genital Human Papillomavirus Infection: Incidence and Risk Factors in a Cohort of Female University Students". Let's also reference http://www.google.com/search?q=Koutsky+LA%2C+Kiviat+NB.+Human+papillomavirus+infections.+In%3A+Holmes+KK%2C+Mardh+PA%2C+Sparling+PF%2C+et+al%2C+eds.+Sexually+transmitted+diseases.+3rd+ed.+New+York%2C+NY%3A+McGraw-Hill%2C+1999%3A347%E2%80%9360.+&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a].

My conclusion for you is no preaching but an observation that all this is because Nature is powerful. As simple as that.

In terms of a clarification, or rather a rationalization of the reported findings, since you have an inkling about tissue rejection problems in organ transplantation (you’ve heard about that, haven’t you), I can draw a parallel for you. Think of the meeting of the male and female flesh as a short-lived tissue implant. If the two tissues don’t know each other, if the female has not known the male for sufficiently long, there is a natural reaction, which the cited experts have found manifested as HPV infection (a hint at how that happens: a stranger’s DNA attacks the recipient).

And what’s all this about that Nature is powerful? Well, it is simply to keep in mind that there are some natural laws and principles, such as the one about action and reaction. And, it’s about that Nature regulates…

So, there will be a reaction to too much of a good thing (or a bad thing, any thing). I don’t want to get into this too much except to recall that, since the sexual revolution of the 1960s, there has been an enormous increase in the incidence of sexually transmitted infections. Had Georgios not invented his test in “the swinging ‘20s”, someone would have had to do it in the “revolutionary ‘60s”…

As it was, Mrs. Sanger had persuaded her wealthy-widow investor that this particular “magic bullet”, her idea of a “magic pill”, was the right approach to reproductive management. Thanks to the Pap, the Western world was sort of ready for the consequences of the Pill at least in terms of the ensuing epidemic of STDs, if not of the epidemic of infertility and of other as yet unrecognized consequences of this fooling with Mother Nature (à la Ms. Sanger and Mrs. McCormick – “as easy to take as an aspirin”).

The fact is that “while an estimated 1 in 4 Americans will get an STD (sexually transmitted disease) in their lifetime,⁴ … the United States continues to have the highest STD rates of any country in the industrialized world.² No effective national program for STD prevention exists… and the American public remains generally unaware of the risk for STDs and the importance of prevention and screening” (per the Kaiser Family Foundation and American Social Health Association). The National Cervical Cancer Coalition writes: “By age 24, at least one in three sexually active people are estimated to have had an STD. Teenage girls are especially vulnerable to contracting gonorrhea and chlamydia, which can more easily infect the immature cervix.”

Oskar Kokoschka, Rejected lover, 1966

Originally, I intended to illustrate these concluding thoughts with a painting by the grandson of Sigmund Freud, Lucian or Lucien, who passed away the other day (a painting of a sad woman’s face showing from under a bed cover, with a clothed man – guess who – standing hands in pockets and just staring at her – it’s #5 in http://pul.se/muse_Cleveland-Cleveland-OH-caroline-blackwood-2LYALDu533r,d5oww4DQguiE).

But then, Oskar’s more colorful impressionist image seems, well, more colorful, and less realistic… as paintings go.

So what, you think to yourself? Okay, sure, you and many others have other things to be concerned about – and who cares about a 15th century heretic? Well, maybe some of us do, and I might on this occasion talk some heresy myself. How ’bout that?

But first, let’s be clear about what heresy is, and what Jan Hus’ heretic speech was about, very briefly. This, in case you don’t read the Wikipedia article http://t.co/lM1SlwF about the medieval thinker, a Czech priest, philosopher, reformer, master and rector at Charles University in Prague, chaplain to the royal court, confessor to the queen,  a key predecessor to Luther and the Protestant movement of the 16th century. It was only some 150 years later that “in 1567 Pope Pius V canceled all grants of indulgences involving any fees or other financial transactions” [indulgence = remission before God of the temporal punishment due for a sin after its guilt has been forgiven].

Master Jan Hus Preaching At the Bethlehem Chapel by Alphonse Mucha, 1916

The Czech king (“Good King Wenceslas” of the English Christmas carol fame) supported Hus preaching against indulgences and other such corruption of “the substance and spirit of the gospel“, but the church’s hierarchy, having declared war on Naples, needed vast revenues to fund the war effort… When the sales of indulgences continued, riots broke out in Prague. Three pro-Hus students were beheaded, and then buried to public acclaim in the Bethlehem Chapel. The hierarchy countered by excommunicating Hus (for the second time). The archbishop “interdicted” the city; that is, he deprived the people of al the spiritual resources of the church, a terrifying development in the middle ages.

This is citing from http://www.victorshepherd.on.ca/Heritage/Jan Hus.htm ; there too you can get the rest of the story about the General Council in Constance, which city was then in Switzerland, with Hus guaranteed a “safe conduct”.

You could see at http://dictionary.reference.com/browse/heresy that the dictionary defines heresy as (1) an opinion or doctrine at variance with the orthodox or accepted doctrine, especially of a church or religious system, and (2) as the maintaining of such an opinion or doctrine. In our time, reference could also be to other types of system or establishment.

More to the point of the Master Jan Hus anniversary, and for a scholarly treatise on the punishment that the medieval intellectual received from the then establishment, treat yourself to http://en.wikipedia.org/wiki/Death_by_burning .

Preparing_the_execution_of_Jan_Hus --- Müller-Baden, Emanuel (Hrsg.): Bibliothek des allgemeinen und praktischen Wissens, Bd. 2. - Berlin, Leipzig, Wien, Stuttgart: Deutsche Verlaghaus Bong & Co, 1904.

For, now that I gave you a preamble, I’ll go into a bit of potentially or mildly heretical talk myself, in relation to cervical cancer (and other STDs, sexually transmitted diseases). It is not heresy to remind ourselves that the HPV vaccines do not cure cervical cancer nor do they prevent infection by all strains of HPV – but it could be heretical to discuss that there has been a grave concern among the public about adverse effects, injuries and even deaths in some young recipients of the vaccines.

And even more so to point out that behavior control (the personal health practices referred to below) is advisable in view of the fact that the cancer is associated with early start of sexual activity and with promiscuity. “It is well known that more than 90% of cases of anogenital warts are caused by HPV. HPV has been implicated in cancers of the cervix, vulva, vagina, penis, anus, and oropharynx. The virus is a necessary cause of cervical cancer. [Note that] as many as 24 million American adults–that is, 1 in 5–may be infected with HPV.”

Sadly, and dangerously for the health of all of us, the above-cited phrase about “It is well known” is misleading because it pertains only to medical people (not even to all of them) as opposed to the general population. “Knowledge about the relationship of HPV to cervical cancer is low even in the United States and the United Kingdom.” One of the sources, on which this assessment is based, concludes: Cervical cancer risk factor knowledge, especially knowledge about HPV is low, even among women with the history of cervical cancer. Younger and more educated women are more likely to have HPV and cervical cancer knowledge accuracy. The importance of personal health practices and the focus on health education should be equally emphasized to achieve successful cancer prevention through vaccination. [Emphasis mine.]

In May, @bioZhena tweeted some on this subject. –

@bioZhena:                                                                                               Can #cervicalcancer #screening be done #simply at home as part of a precise determination of #fertile days? http://to.ly/xEO #womenshealth

@bioZhena:                                                                                               Why is it important to do regular #cervicalcancer #screening – besides the fact that #Merck says so? #Gardasil Why the Ovulona? http://to.ly/xEO

RT @BelievnTomorrow Julie Hewett by @bioZhena:                        The Pope, Condoms and HPV: What Pope Benedict May Not Know #PreventCC #HPV http://ow.ly/4Vo4W

@bioZhena:                                                                                            #fem http://bit.ly/k7As90 GARDASIL does NOT prevent all of #cervical #cancer Merck says: It’s important to continue regular #cervicalcancer #screening

@bioZhena:                                                                                     #Gynecology experts divided http://to.ly/awuh whether deaths & blood clots serious but rare side effects of the #HPV #vaccine #Gardasil #fem

@bioZhena:                                                                                       #Gardasil unexplained death http://to.ly/aB9A Coroner raises questions about #HPV #vaccination ¬es 78 US deaths related to Gardasil (51 by CDC)

@bioZhena:                                                                                               The Truth About #Gardasil http://to.ly/awu9 by @mariangreene04 No known treatment to help these girls as they suffer in silence #womenshealth

@bioZhena:                                                                                                             http://to.ly/awun reports of injury, death related to #Gardasil #HPV #vaccine It prevents positive #Pap not CC [Cervical Cancer] Think Ovulona http://to.ly/xEO

Alphonse Mucha: Madonna Of The Lilies

There then appeared a physician’s tweet “in defense of” the HPV vaccines, dismissive of the public concerns:

@DrJenGunter tweeted:                                                                              @bioZhena don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals

@DrJenGunter tweeted:                                                           @bioZhena all the US deaths post Gardisil have been investigated and no causal relationship identified. Several good publications.

@bioZhena responded with a request for the source of the info, i.e., for those “several good publications”.

@bioZhena:                                                                                              Thanx @DrJenGunter for your msg on #Gardasil #Cervarix safety. Would you share references? I got CDC http://to.ly/aB3v                8% VAERS were serious (defined) = 1,468.

@bioZhena:                                                                                @DrJenGunter #Gardasil http://to.ly/aB4c ~half the adverse reactions required a trip to the ER & about 20% of those girls “Did Not Recover”

@bioZhena:                                                                                                 RT @DrJenGunter: @bioZhena 2011 meta analysis in peer reviewed journal > 44,000 girls no increase in adverse events with Gardasil vs. control #vaxfax — Any chance that you’d share the 2011 meta analysis reference, please?

@bioZhena:                                                                                             #Gardasil Gardisil Silgard Re: @DrJenGunter 2 @bioZhena “don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals”. Please cite them disproving deaths, harm. Email:  vaclavkirsner@yahoo.com . I look forward to hearing from you. Hard data is indeed necessary.
Meanwhile, CDC http://to.ly/aB9I (albeit not “in real journals”) states, among other things:
Blood Clots
There have been some reports of blood clots in females after receiving Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.
Deaths
As of February 14, 2011, there have been 51 VAERS reports of death among females who have received Gardasil. Thirty two of these reports have been confirmed and 19 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination. END QUOTE.

Whereupon @bioZhena suggests: The anti-Hippocrates harm does not go away, and cervical cancer screening is no less needed post-vaccination than without it. That’s why @bioZhena’s interest in the topic, as we propose to introduce a better screen than the Pap – but this requires some funding. With our screen done automatically by women at home (in the background of the primary use of the Ovulona™ monitor), the concern that the Pap frequency would suffer in the West is or can be answered, and providing the screen to the population in the non-West countries is a big plus.
Posted by: http://twitter.com/bioZhena   5/26/2011 12:48:52 AM from Twitzer

@bioZhena:                                                                                                  India halts #HPV #vaccine trial after 6 girls die, US does nothing – 67 deaths http://to.ly/aALf #Gardasil & #Cervarix #cervical #cancer

@bioZhena:                                                                                        #vaxfax #womenshealth Worth repeating: Vaccination does NOT replace routine #cervicalcancer screening – does NOT protect against all #HPV types http://to.ly/aB3v And: Vaccines do NOT cure cervical cancer

@bioZhena:                                                                                              #HPV #PreventCC even vaccinated must screen4CC [must screen for cervical cancer]: 20-30 yrs old screen every 2 yrs, 30-65 yrs every 3 yrs if Pap is normal http://to.ly/aGu3

RT @MedscapeOBGYN by @bioZhena:                                             Cervical Cancer Screening Every 3 Years for Most Women http://bit.ly/mhop42

@bioZhena:                                                                                              #Vaccination does not replace routine #cervicalcancer screening! Vaccines don’t protect against all #HPV types http://to.ly/aB3v & they don’t cure it

Alfons Mucha, Malířství

@bioZhena:                                                                                     Comment from http://to.ly/aCD3 #Cervical #cancer “smear tests are invasive uncomfortable embarrassing & often are badly diagnosed”. Hear hear!

@bioZhena:                                                                                                  Comment from http://to.ly/aCD3 “De-stigmatize #cervical #cancer and do some work to make test less unpleasant – more #women will go”. Hear hear!

@bioZhena:                                                                                       #womenshealth RT @BelievnTomorrow #HPV and #cervical #cancer – (We can do better!) http://ow.ly/506ha ->Easy home screening http://to.ly/weK

@bioZhena:                                                                                                e-tech #medtech 4 getting #women everywhere screened 4 early signs of #cervical #cancer http://to.ly/aGtS Innocuous, affordable.

That’s it – we can do better than the Pap.

But does anyone hear this?

@bioZhena:                                                                                            What is the significance of the #HPV epidemic? http://to.ly/aB44 Already in 1842 a Verona #doctor observed: #cervicalcancer is due to sexual activity http://to.ly/aB46

#Women who get #STD screening can avoid #infertility caused by #STDs http://to.ly/aIyq  Future home screen http://to.ly/xEO http://yfrog.com/kfgl0dfj

@bioZhena:                                                                                              Here is a thought. Daughters of @BarackObama too will benefit from our #medtech #fertility #cervical #cancer screen. See about the Ovulona at http://to.ly/xEO

Is this a heresy?

December 5 is the eve of St. Nicholas Day, the patron Saint of many people, cities and countries – including the largest one [ http://en.wikipedia.org/wiki/Saint_Nicholas#Deeds_and_miracles_attributed_to_Saint_Nicholas ]. St. Nicholas is remembered and celebrated in similar ways in some countries, rewarding well-behaved children but not the misbehaving ones… Which is why St. Nicholas, known as Svaty Mikulas, visits the children at home, in certain parts of Central Europe, in the evening along with an Angel and a Devil (Cert). The Saint asks the parents about the kids’ conduct…

Josef Lada - Mikulas, andel a cert

Josef Lada – Mikulas doma

I share with you a depiction of the tradition drawn by Josef Lada in the troubled 1930s, an idyllic tradition of an industrial people, which they keep to this day…

Besides numerous miracles, this most popular of Saints was and is reputed for gift-giving (hence the commercialized Santa Claus transformation morphing St. Nicholas  with a Western or Northern European Father Christmas later on in the month of December).

There are numerous legends about Saint Nicholas’ miracles and his deeds of help. Perhaps the most famous one is about the three daughters of an impoverished man who could not afford a proper dowry for them, dowry being an ancient habit, the original purpose of which “was to provide ‘seed money’ or property for the establishment of a new household” – and we are now talking about the 300s CE [Christian Era].

STOP PRESS

Now, in AD 2011, I venture to think that Svaty Mikulas aka Saint Nicholas would approve of seeding our project, too, because it is actually to help those young women as well! Please check out the following temporarily inserted pledge proposition, which will not stay here longer than after the Valentine’s Day (90 days from November 26, 2011). You can secure a well discounted Ovulona device by promising to prepay it or a portion of it. And tell others about this! See:

http://www.fundageek.com/Project/Detail/237

END OF  STOP PRESS

The saint Bishop of Myrna saved the girls from the fate of slavery and prostitution by secretly dropping “three purses (one for each daughter) filled with gold coins through the window opening into the man’s house”, which gift made the young girls “eligible” again. It is also said that he dropped the gift down the chimney where stockings were hanging “over the embers to dry, and that the bag of gold fell into the stocking”. That’s beside the point because we are not discussing Santa of Christmas, but rather we are remembering St. Nicolas of December 6.

Jan_Steen_Het_Sint_Nicolaasfeest,                               The Feast of St. Nicholas

In those times many, many centuries ago, the chief purpose of young women’s life was motherhood, naturally within a marriage, hence the said dowry habit. In our times, many things have changed, including, unfortunately, young women’s attitude towards motherhood. Well, not just young women’s attitude…

Motherhood must be held in high esteem to reverse the trend reflected by an outcry in tweeter-sphere that’s a part of life nowadays: “I never felt marginalized as a woman until I became a mother”. Now this is very sad. Sad for society since the opposite should be the case.

Motherhood is the most important “job” in the world, and this is not some cute old-fashioned thought. Women bear enormous responsibility for the health of the nation, of humankind. Society should pamper them. Meaning: Society should be organized based on the recognition of Mother Nature’s design, which design – with the optimal years for motherhood in the early twenties – does not go away only because nowadays we can do all kinds of things – including octuplet pregnancies at grandmotherly age.

One consequence of the referenced changes is the currently common delays in getting married, and especially delays in bringing children into the world, starting a family. In other words, the unfortunate consequence is motherhood in later years of life than Nature intended. And then there are other consequences. Among them, prematurity.

Lou Beach, Preggers

@DrJenGunter not too long ago tweeted on prematurity, the most common cause of infant morbidity and mortality in the U.S.: “I just wrote a book on prematurity. Personal and professional experience”. See The Preemie Primer: A Complete Guide for Parents of Premature Babies–from Birth through the Toddler Years and Beyond [Paperback], Jennifer Gunter MD (Author) at http://www.amazon.com/Preemie-Primer-Complete-Premature-Babies/dp/0738213934/

Here is a citation [from http://www.preemieprimer.com/ ]:

My son Victor has dystonic cerebral palsy. He weighed 843 g at birth and had a grade 2 IVH. The bleed resolved in the NICU without hydrocephalus.

He is seven years old now. He is very stiff and is so shaky on a bicycle that we have given up trying for now. He couldn’t stand on one foot until he was 5. It took a very long time for him to get the hang of swimming and at the age of seven he is by no means a fish, but I feel if he were to fall in a pool he could keep his head above water. His digestive tract is very affected, but we have figured out ways to minimize these issues. It took countless hours of OT and thousands of hours of him practicing, but his writing is beautiful and God know where he gets his spelling ability from. He hopscotches like a pro. He is reading a grade level ahead. All without a CT scan or an MRI.

Based on his exam and his problem areas I am sure his cerebellum is a mess. In fact, I wonder if I would have pushed him so hard if I had seen a brain scan before we left the NICU?

“What we know about prematurity” is reviewed by the March of Dimes Campaign at http://www.marchofdimes.com/Mission/prematurity_indepth.html .

“Today more than 1,400 babies in the United States (1 in 8 [= 12.5%]) will be born prematurely. Many will be too small and too sick to go home. Instead, they face weeks or even months in the newborn intensive care unit (NICU). These babies face an increased risk of serious medical complications and death; however, most, eventually, will go home. … In fact, the rate of premature birth increased by more than 20 percent between 1990 and 2006. … The rate fell to 12.3 percent in 2008 from 12.7 in 2007, a small but statistically significant decrease.

Why women deliver early? In nearly 40 percent of premature births, the cause is unknown. However, researchers have made some progress in learning the causes of prematurity. Studies suggest that there may be four main routes leading to spontaneous premature labor.”

Štyrský - Marriage

Do refer to the referenced article for more about the four main causes:

1. Infections and/or inflammation.
2. Maternal or fetal stress.
3. Bleeding.
4. Stretching.

And then there is this: These four routes are not the only things to consider. Other factors, such as multiple pregnancy, inductions and cesarean sections, can also play a role. (Mostly man-made factors, we note. I say “mostly” because some multiple pregnancies happen also to women who did not get pregnant through the Artificial Reproductive Technologies… )

Prematurity is bad for infant, parents, and public health. We at bioZhena propose to contribute to the reduction of its prevalence, by making the FOLLICULOGENESIS IN VIVO™ [FIV™] technology available for routine use by women and their physicians. As a particular example, in relation to the referenced other factors, we propose to make it possible to compute the Expected Date of Delivery (EDD) based on the expectant mothers’ folliculogenesis data.

The idea is to get away from the gestation calculation popularized about 200 years ago in 1812 by a Dr. Naegele, for whom the 40 weeks or 10 lunar months rule of obstetrics is named. This rule of 280-day gestation assumes that the mother ovulates on day 14 of a 28 day menstrual cycle, which the readers of bioZhena’s Weblog know that it is an unrealistic assumption.

America in 1812, the time of Dr. Naegele’s 200 years of fame

Napoleon & carabiniers_in_front_of_Moscow_1812

Allegedly*, it was Dr. Hermanni Boerhaave, in his time a highly respected academic physician, botanist and chemist, who read in the Bible that pregnancy should last 10 lunar months. He is said to have formulated – in the 1700s – a way of calculating the expected date of delivery (EDD).

Thus, expectant mothers get EDD today based on the myth of the baroque-era Boerhaave … Yet, already Aristotle taught that “the human fetus is expelled … at any period of pregnancy …; moreover, when the birth takes place in the eighth month, it is possible for the infant to live.”

The gist of the bioZhena hypothesis is this: The EDD can be projected quite well from ultrasonic measurements of the unborn baby’s head and body size, but for a more convenient, affordable and consequently more practical solution, we propose to seek a correlation between the Ovulona FIV™ attributes such as cycle length and the EDD/EDC. Importantly, this will be done by using the date of insemination, which will be easily – electronically – recorded by the user of the Ovulona™ as an integral part of the routine.

Trying to be fair or considerate to the women’s healthcare classics, I report an obgyn.net paper at http://www.obgyn.net/fetal-monitoring/fetal-monitoring.asp?page=cotm/9807/cotm_9807 . It is titled “’Back to the Future’ for Hermaani Boerhaave, or, ‘A rational way to generate ultrasound scan charts for estimating the date of delivery’” by Dr David J R Hutchon, Consultant Obstetrician, Memorial Hospital, Darlington, England. This is about the ultrasound approach, and he comments that: QUOTE “the approach mimics, in modern terms, the method originally formulated by Boerhaave. … If Boerhaave had had an ultrasound scanner, his paper might have read something like, ‘It is proved by numerous observations that 99 out of 100 births occur 22 weeks (at 18 weeks gestation) after the biparietal diameter of the fetus is 40mm’ (Fig 1).”

Besides his Figure 1, I also share Mr Hutchon’s (a British medical doctor, when Consultant, becomes Mr again) Fig. 2, “Regression analysis showing line fit plot. The number of days between scan and delivery has been converted to conventional gestation by subtracting from 280. The lower and upper dotted lines represent delivery at 42 and 37 weeks respectively.” QUOTE UNQUOTE.

Gestation age vs. crown rump length by DJR Hutchon

Gestation vs. biparietal diameter by Hutchon

Biparietal diameter is the (outer – inner) measurement of the fetal skull echo. Crown-rump length (CRL) is the measurement of the length of human embryos and fetuses from the top of the head (crown) to the bottom of the buttocks (rump). In humans, the fetal stage of prenatal development starts at the beginning of the 11th week in gestational age, which is the 9th week after fertilization. These are the Wikipedia reported definitions. The two weeks between 9 and 11 assume the “regular” length of the menstrual cycle, which is a theoretical assumption that could very likely be incorrect in practice, in the given woman and in the given last cycle of hers (because regularity is a myth, too).

In addition to the convenience, affordability and practicality of the bioZhena approach, do not overlook the feature that the data will be personal to the given woman, and the measurement will not refer to LMP. It will not rely on the woman’s recollection of her last menstrual period (instead, it will refer to the last electronically recorded intercourse); and it will not subject the baby to unnecessary ultrasound radiation.

For more on the topic, try under Gestation in the Alphabet of bioZhena http://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf (or http://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena/ ). See also the discussion under Parturition, where we express the expectation that parturition management will be revolutionized by the introduction of the Ovulona into obstetric and gynecological practice.

Anderle - Pasek 06

Summary Definitions [quoted from http://www.righthealth.com/topic/Fetal_Age ]:

Gestation is the period of time between conception and birth, during which the fetus grows and develops inside the mother’s womb.

Gestational age is the time measured from the first day of the woman’s last menstrual cycle [LMP] to the current date. It is measured in weeks. A normal pregnancy can range from 38 to 42 weeks.

Infants born before 37 weeks are considered premature. Infants born after 42 weeks are considered postmature. (Note: 42 x 7 = 294).

Especially with the challenged menstrual cycles that are particularly irregular in length, referencing the LMP in the reckoning can easily introduce a significant error. Perhaps that is why the above summary definition of normalcy is 38 to 42 weeks but prematurity is “before 37 weeks”? (A week here, a week there…) Read also the earlier post http://biozhena.wordpress.com/2008/01/11/about-the-edd-andor-edc-issue-and-a-request-for-input-from-readers/ .

Tomáš Císarovský - Kukátko

280 may have been in the Bible, but it ain’t necessarily right. We’ll see whether 266 is, and whether it is a worldwide constant, which is doubtful. If for no other reason, global constancy is doubtful because it was reported from India that “Mean gestational age at the onset of labour for women native to the area of study was 272 days (standard deviation 9 days). Pregnancies beyond a duration of 280 days showed significantly increased perinatal morbidity.” (Referencing the above righthealth.com definitions, we see 294 – 280 = 14. A week here, a couple of weeks there…)

Well, 272 – 14 = 258. Not 266, and that number is of interest because per Encyclopedia of Childhood and Adolescence, ”a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception” (article Gestation Period and Gestational Age).

And then you have the oprah.com article, which asks, “Will the labor start naturally on time, or will the baby be so late that induction or Caesarean section is necessary?”: http://www.oprah.com/relationships/Is-Pregnancy-Really-40-Weeks-Long . While debating the validity of the word “necessary” is not the point here, the author there refers to data from studies that concluded greater than 280 days due dates (288 days in one study), of which one study was in Sweden.

A hypothesis can be that hot climates may lead to lower gestation periods than cold climates. This would be a hypothesis based on two data points and a common sense for “the babies taking longer when it’s cold outside”… We’ll want to compare, say, data from Inuits and Lapps on the one hand with data from equatorial Africa and Philippines and/or Indonesia on the other. Logically, we’ll control for factors known or suspected as being involved, such as those four main causes listed above – and age, parity and other factors already explored by people such as Mittendorf in the 1980s.

Kupka - Creation de l homme

The idea is that routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation, which is available to the women receiving IVF or artificial insemination. The data will be personal and the geography of the birth will be noted (as well as ethnicity), with data sooner or later coming from all corners of the world.

Capturing and working with the fertilization date should by and of itself be an improvement over the current way of EDD/EDC assessment. An improvement over the paradox of modern obstetrics and gynecology handling the most important aspect of reproduction by means of some biblical myth, and having become more and more interventionist probably at least in part because of that myth. Reference a recent tweet: Maternity Care In America Rife With Systematic Failures l Being #Pregnant http://su.pr/2j91wY “most people don’t know normal birth”. This refers to the medical staff.

That these thoughts are sensible, and that the chief problem is the LMP, is supported by ultrasound studies such as “Gestational age and induction of labour for prolonged pregnancy” by Jason Gardosi, Tracey Vanner, and Andy Francis (Perinatal Research, Audit and Monitoring, Department of Obstetrics and Gynaecology, Queen’s Medical Centre, Nottingham, UK) in British Journal of Obstetrics and Gynaecology, July 1997, Vol. 104, pp. 792-797 – [ http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.1997.tb12022.x/pdf ].

Citing from this study of more than 24.5 thousand pregnancies: “Menstrual dates [LMP data] systematically overestimated gestational age at term when compared with scan dates… suggesting that most pregnancies which are considered ‘prolonged’ according to menstrual dates are in fact mis-dated. The median gestational age for induced labours was 286 days by last menstrual period but only 280 days by scan, and most (71.5%) inductions done post-term (> 294 days) according to menstrual dates were not post-term if scan dates alone are used to calculate the gestational age.“

This study was a retrospective analysis of computer files of 24,675 pregnancies delivered in a teaching hospital between 1988 and 1995.

Here is their graphical summary of distribution of deliveries as a function of gestational ages by ultrasound scan dates. The modal length of pregnancy was 283 days by LMP and 281 days by ultrasound scan.

Deliveries vs. gestational ages by ultrasound scan dates

Their most explicit statement in support of our conviction and plan is this citation: “Even if the date of the last menstrual period is recalled with accuracy, delay in ovulation can result in over-estimation of the true gestational age, which results in an apparent prolongation of pregnancy.” The authors also cite a 1972 paper in American Journal of Obstetric and Gynecology in support of the just cited statement.

The Gardosi et al. paper concluded: Regardless of obstetric and maternal views of the advantages and disadvantages of routine induction policies, our results suggest that most post-date inductions are unwarranted on the basis of gestational age. The incidence of prolonged pregnancies can be considerably reduced by establishing dates by ultrasound alone.

Needless to say, a similar plot for deliveries in India would show the spontaneous labor peak earlier (272 days by one study in tropical Manipal) while a Scandinavian plot would be shifted in the opposite direction; both were referenced above.

I’ll be darned if the introduction of the Ovulona into the gestation arena should not bring some order and peace (as opposed to the mess and anxieties of today) – just like its inevitable usefulness in the achieving-pregnancy arena! All in one package and no Saint Nicholas miraculous assistance will be required by the future users, although we will not write here the same for bioZhena.

———

* I write “allegedly” because I spent many an hour looking for evidence of truth in this allegation, only to find the Dutch man an impressive medico-scientific mind and an impressive likeable character – but no evidence of the biblical dogma ascribed to him. As I write this note, I am going once more through the tedious but interesting Dr. Boerhaave’s “Academical lectures on the theory of physic” of AD 1744. The man’s fame and authority was such that “a Chinese mandarin, seeking advice, addressed his letter to ‘Boerhaave – Europe’, and it was delivered”. See http://books.google.com/books?id=QTUVAAAAQAAJ&printsec=frontcover&dq=Hermanni+Boerhaave+1744&source=bl&ots=NCeCN4gLdd&sig=SoUA_WS6iSkh2A8WpBX7S4o54Uw&hl=en&ei=ebP-TP2WBIX2tgO12-mvCw&sa=X&oi=book_result&ct=result&resnum=4&ved=0CB8Q6AEwAw#v=onepage&q&f=false

After the optimum fertility age of the early twenties, achieving motherhood gets more difficult. It becomes even more essential than ever before to know your three fertile days, during which – and only during which – conception can occur.

The simple basic principle is: Fertility status detection must be easy and reliable. PLUS early pregnancy diagnosis is really important, and it should be built-in, an integral part of the conception-aiding tool. Why? Because of annual 600,000 miscarriages – per CDC statistics – out of 6 million US births, which means at least some 10% of pregnancies are lost to early pregnancy loss (EPL), miscarriage, or stillbirth.

Many EPLs go unnoticed. The EPL is a part of the TTC [Trying To Conceive] or subfertility/infertility problem. Our Ovulona monitor of FOLLICULOGENESIS IN VIVO™ is the solution – because it is accurate and comprehensive.

Comprehensive means that the Ovulona™ detects the 3 fertile days for conception, and it will also automatically detect pregnancy immediately upon conception. Similarly with early pregnancy loss — its detection is the inverse of pregnancy detection, which both involve the follicular waves. Like this:

Follicular waves disappear = pregnancy detected

versus

waves reappear in early pregnancy =  early pregnancy loss detected.

Furthermore, the cyclic profile data captured by the Ovulona can be used by your healthcare provider to assess what is going on, and provide more effective help.

DIFFICULT USE OF EXISTING OPKs [Ovulation Prediction Kits] is shown in the following July 2010 tweet by @WannaBeMom: “1st month using opk. Do the lines usually start light and then get darker day by day or do they ever go back & forth b4 ovulation?”

Our electronic device will take the WannaBeMoms into a different world of baby-making. See http://to.ly/7O2u (download 16 narrated slides, ~12 MB due to the audio); or http://to.ly/757m two pictures with legend; or http://to.ly/VCF = a pictorial “Pregnancy and birth control how-to by bioZhena”. Or http://to.ly/vUz = see the August 2010 bioZhena’s Weblog post about How follicular waves will be used…

Twitzered as follows:

#stillbirth #miscarriage issue #Fertility detection must be easy & reliable PLUS early #pregnancy #diagnosis is … http://twitzer.com/lCgBk

For a woman in her 30s who’s had a miscarriage or even two or three, “any delay in attempting conception could further decrease the chances of a healthy baby”, says CNN reporting on a medical study, http://ht.ly/2mlwb .

“Study: Women who conceive within six months of miscarriage reduce risk of another.”

These are fundamental principles.

And another principle, not brought up by the CNN or by the study itself, is that a tool for monitoring the early stage of pregnancy for EPL is most desirable. We’d say, mandatory. The Ovulona device monitors (or tracks the process of) folliculogenesis in vivo, which includes the follicular waves that occur after ovulation. The waves disappear upon conception because the reproductive system does not go into another menstrual cycle – it’s pregnant.

In case of EPL, Early Pregnancy Loss (miscarriage), the waves will come back. Early Pregnancy Loss, or Early Embryonic Mortality, is quite a common sad experience of many of us.

The essential point made here is that the woman’s and her physician’s decisions should be guided by the folliculogenesis cyclic profile (and/or its distortion due to distress – of any kind). The woman and her doctor should not make decisions or pass recommendations working in the dark, and the data, on which any decision should be based, must be personal to the given patient.

That’s what the Ovulona from bioZhena is for. Personalized medicine. Evidence based medicine. Should you be new to this, http://to.ly/xEO is an introduction. Another intro, with more pictures, is http://to.ly/VCF — 6 pictures with explanations of the basics of FIV™, folliculogenesis in vivo.

This is one of the 6 pics about “what’s going on here”, http://to.ly/1k9L , and specifically: The follicular waves, which occur after ovulation [when the system prepares for the next menstrual cycle], cannot remain in place after fertilization succeeds and conception takes place [because the regime change is even more profound]. That is the principle of instant detection of pregnancy.

For a narrated slide that’s captured here, view slide #6 in the powerpoint presentation https://www.box.net/shared/bkc38iksm2 . And the August 25, 2010 post in this blog will also give further information, some of which is repeated here – to impress this on you.

HCG or Human Chorionic Gonadotropin laboratory signature of the biomarker - detected in a pregnant woman’s urine about 2 weeks into her pregnancy by a HPT home-use urine test - as a color change (into which color the HPT reduces the illustrated complex lab signature)

Should the conceptus [product of conception, early embryo] be lost to EEM, Early Embryonic Mortality (miscarriage), the follicular waves come back to be seen by the Ovulona. That’s the principle of early detection of the miscarriage, and of detecting the return of the non-pregnant condition. It would not be practical to try and do this with the HPT, would it.

Trying to conceive again should be based on the personal FIV™ [FOLLICULOGENESIS IN VIVO] cyclic profile data generated by the patient, that is, by the woman trying to have a baby. This is a principle of evidence-based medicine. Personalized medicine.

Posted by: http://twitter.com/bioZhena 8/22/2010 7:05:08 PM from Twitzer

Entre Les Trous De La Memoire by Appia

The Ovulona is intended to help people such as those writing in a forum as follows:

My partner and i started trying for a baby in jan And Concieved in the first month. Unfortunately in march at 8 weeks I had a miscarriage. We have been trying since with no luck. Could something be wrong. Please help this is really getting me down. http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=57881&f=5

We got pregnant the first cycle with both my ds and dd. I am most likely moving to cycle #11 with this baby. We did conceive on the second cycle of trying with baby #3 but we miscarried a week later. Nothing since then. I’m not sure why this time is taking so much longer. http://www.mothering.com/discussions/showthread.php?p=16029816

Can anyone advise? My daughter has been trying to get pregnant for several years. Her husband is fine. My daughter has now been asked to go for a scan which scared the life out of me (you automatically think something is horribly wrong). Can someone tell me what the scan is about – what sort of scan is it? http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=31528&f=5

The information contained in the folliculogenesis cyclic profile, as illustrated in the slide captured above, is meaningful and can help the healthcare provider to answer questions such as these.

Here is the premise: To #conceive a #pregnancy the couple must absolutely do their #TTC in the woman’s #fertile time, which is a window of 3days: http://to.ly/4Fih . The unspoken corollary is that advancing age does not help, and neither do things that pollute our life, that is all those various stressors.

Besides which, you need to know not only when your ovulation is approaching but also that it actually occurs. No guessing, no mere assuming that it does, or that it did.

Human ovulation caught on camera by Dr Donnez

This photo of the ovulation event is unique, and it clearly cannot be the answer to the necessity of knowing that ovulation occurs in the menstrual cycle of interest to you. Also unique is that the Ovulona™ will do the determination of ovulation for you automatically – in your hands, at your convenience, with no discomfort. It’s one part of the FOLLICULOGENESIS IN VIVO™ simple self-monitoring procedure with the Ovulona™. In doing so, you’ll gather and automatically store in the device data of diagnostic significance to your healthcare providers. Your physician’s decisions should be guided by the folliculogenesis cyclic profile. Yours, too.

See below how to secure your  substantially discounted Ovulona Fertility Monitor

Here now, how #ttc people need our Ovulona: Disgusted with peeing on a stick, writes stressed out, frustrated, messed up @socalledttclife: “On to IUI #4 we go” [IUI = Intra Uterine Insemination procedure], http://ow.ly/351yf .

She blogs: “…Progesterone supps suck. No, really, Crinone is now numero uno on my most hated list right there behind peeing on a stick and betas. It totally MESSED with my head this cycle. It made me crampy, it gave me headaches, it delayed my period—ALL of the things that are usually early pregnancy symptoms. Damn you, Crinone!”

This is one example and one reason why a month ago the following tweeting dialog took place: RT @resolveorg What’s the one thing you wished the public knew about #infertility?

bioZhena’s answer = Before #fertility #drugs, try right timing http://to.ly/5dUR .

That is: Quite apart from the fact that even the artificial reproductive procedures such as said IUI have to be performed at the right time in the patient’s cycle to have a chance succeeding. Before undergoing the “heroic procedures” of Artificial Reproductive Technologies [ARTs], explore the normal natural approach, and – naturally – you need a reliable timing tool to know when exactly your 3-day fertile window occurs. Good thing you are still this side of 35, although it would be much better if you were this side of 25. Or 30, at least. But that’s water under the bridge… unfortunately.

Per Google Alert, Today’s #TTC Trying To #Conceive forum has 4 results that are symptomatic of the TTC world – and how that world needs our Ovulona diagnostic tool with essential folliculogenesis data for the physicians:

1. Conceiving in our 20s http://www.mothering.com/discussions/showthread.php?p=16007861

2. healthy excersise while TTC – TTC- Trying to conceive Group so im a gymaholic… Before I go to my GP again with yet another silly question, what do you girls think, with your experience and knowledge, about my standard work out ’plan’ below? Is this too much while TTC? … Thoughts? Please dont make me not do it

social.kidspot.com.au/topic.php?topic_id=8490

3. First time TTC with clomid and really nervous, any suggestions?? Forum · PCOS Treatments and Conditions · Infertility and Trying to Conceive; First time TTC with clomid and really nervous, any suggestions? …
www.soulcysters.net/showthread.php?t=317229&page=2

4. Pregnancy Forum UK : UK Pregnancy Forum Parenting and Baby forum …
hey all i had a positive opk on fri am but this morning days later had twinges on left hand side which feel like op is it possible that i have only just …
178.19.113.123/viewtopic.php?f=8&t=114228&view…

#PCOS patients should monitor folliculogenesis & the effects of any treatment on it. See http://to.ly/MJU , and for what it is go to http://to.ly/757m , and see how an obgyn physician related to the technology even early on when it was still in a rather crude prototype form: http://to.ly/vG0 .

As we expressed earlier in this blog:

It is advisable – and safer – to go about TTC, Trying To Conceive, without the use of chemicals, especially man-made chemicals, and note that herbal preparations are chemicals too. Monitoring (measuring) the effects of anything you ingest is basically a must, if you do not play “Russian roulette” with yourself, your offspring, your family.

#Obese peri-pubertal girls may have hyperandrogenemia which can be forerunner of #PCOS: http://to.ly/6PrK .

Not all #women with #PCOS have difficulty achieving #pregnancy, but anovulation is a common problem: http://to.ly/5mjs .

#PCOS problems are more about #prevention of diseases due to PCOS = #endometrial #cancer #diabetes #heart disease #strokes: http://to.ly/5mjs .

RT @kevinmd Too many young children are medicated with powerful #drugs http://goo.gl/fb/xXu5q – Too many #women too. Will this ever be seen as abuse?

Durer, Albrecht - The Temptation Of The Idler (or The Dream Of The Doctor)

Difficult #conception is tied to #pregnancy complications: http://to.ly/4Fih #fertility #TTC #conceive #womenshealth . Read also: http://to.ly/6ahN .

#Natural vs. #Clomid in Dr. Randine Lewis: From #Infertility to Motherhood, http://to.ly/60v6 . Wrote the #medical doctor:

“I was experiencing hormonal problems. My joints ached, I had lower back and knee pain, I had to urinate frequently, I had night sweats, I was experiencing hair loss and my periods were extremely irregular and sometimes nonexistent.

A medical work-up revealed my estrogen and progesterone levels were alarmingly low, resulting in my inability to conceive. The doctor recommended that I take Clomid, a drug designed to hyperstimulate a woman’s ovaries to produce more eggs, thus increasing the chances of pregnancy. This advice seemed wrong to me; what about the underlying problem? Was it not unwise to hyperstimulate my ovaries when the problem obviously resided in my whole hormonal system?”

Now, put that in context with More About Clomid, Serophene, Clomiphene citrate or Clomifene, http://to.ly/5dUr . Why popping pills is not the best.

Is #ovulation enough to #conceive? http://to.ly/4Fih . Not really. You have to satisfy 4 factors, 4 prerequisites:

1. good health,

2. right insemination timing,

3. fertilization works,

4. embryo lives, is not lost to early embryonic mortality

#Stress can do unwanted things to #women & #menstrual cycles: http://to.ly/yBk . Subfertility can result.

kirchner_red_elizabeth_riverbank

Every year past the optimal fertile age of early twenties is making things harder – on would be mum, on baby, on healthcare system, on humankind.

Consequences of conception difficulties should not be taken lightly.

That is one of the reasons why I propose, dear reader, that you look into the following proposition, whereby you can secure a substantial discount on your future Ovulona Fertility Monitor by promising to prepay at least a portion of the discounted price. Do check it out at http://www.fundageek.com/Project/Detail/237 . You’ll see that it’s a win – win! Really.

Refer to Early Pregnancy Loss,  http://emedicine.medscape.com/article/260495-overview . Note: Chief Editor is Professor Lee P. Shulman, MD, FACOG – one of bioZhena Corporation’s Board of Medical Advisors.

Sonography scene. Some contrast vis-à-vis the Ovulona™!

Excerpted from said Medscape overview:

Early pregnancy loss is unfortunately the most common complication of human gestation, occurring in at least 75% of all women trying to conceive. Most of these losses are unrecognized and occur before or with the next expected menses. Of those that are recognized, 15-20% are spontaneous abortions (SABs) or ectopic pregnancies diagnosed after the pregnancy is clinically recognized.

The incidence of spontaneous miscarriage is 10-15%, whereas the rate of recurrent miscarriage is 3-5%.

Approximately 5% of couples trying to conceive have 2 consecutive miscarriages, and approximately 1% of couples have 3 or more consecutive losses.

Early pregnancy loss is defined as the termination of pregnancy before 20 weeks’ gestation or with a fetal weight of <500 g.

The gestational age at the time of the SAB can provide clues about the cause. For instance, nearly 70% of SABs in the first 12 weeks are due to chromosomal anomalies. However, losses due to antiphospholipid syndrome (APS) and cervical incompetence tend to occur after the first trimester. END OF QUOTE.

The mentioned significance of gestational age brings up the importance of our plan for the Ovulona, which will have the users record in a simple manner (with the Ovulona) all instances of sexual intercourse, from which the true gestational age – upon conception, whether planned or unplanned – will be measured, and the EDD/EDC will be computed from that data.

This evidence-based procedure will revolutionize obstetric practice. But now back to the focus on the use of the follicular waves in the process.

For a woman in her 30s who’s had a miscarriage or even two or three, writes CNN’s Health.com ( http://ht.ly/2mlwb ), “any delay in attempting conception could further decrease the chances of a healthy baby”. This is a fundamental principle.

Further, they write, with reference to a BMJ publication, “Study: Women who conceive within six months of miscarriage reduce risk of another… The women who conceived within six months also had better overall outcomes. They were about 10 percent less likely to have a C-section or a preterm delivery, and about 15 percent less likely to have a baby of low birth weight than the women who waited up to a year.”

This is a highly suggestive conclusion, implying the need to know as soon as possible. The sooner the better for attaining happiness.

Angelo Bronzino - Allegory_of_Happiness, 1564

Another fundamental principle, not brought up by CNN or by the study itself, is that a tool for automatic monitoring of the early stage of pregnancy watching out for EEM [Early Embryonic Mortality] is most desirable, to put it mildly. Our Ovulona™ device is perfect for that.

The Ovulona monitors folliculogenesis in vivo, which includes the follicular waves occurring after ovulation. The waves disappear upon conception (the pregnant system does not go preparing for another menstrual cycle, which the follicular waves signify). The follicular waves disappear as soon as conception takes place and the woman is in early stages of pregnancy. In case of miscarriage, the waves will come back.

The point made here is that the woman’s and her obgyn’s decisions about trying for pregnancy again should be guided by diagnostic data. The data on which any decision should be based must be personal to the given patient – not based on statistical outcomes of studies such as the one referenced above.

That’s what the Ovulona™ from bioZhena is for, the tested and the putative uses of which are discussed throughout the bioZhena’s Weblog. For a pictorial overview with narrative, you can go to http://to.ly/VCF and peruse the 6 pictures with brief explanations of the basics of FIV™, the ovulographic™ monitoring of folliculogenesis in vivo™.

This one of the 6 illustrations, http://to.ly/1k9L, is about “what’s going on here”.  In other words, what is FOLLICULOGENESIS IN VIVO™, the mechanism of the cyclic profiles, the mechanism of menstrual cycles.

The unprecedented wealth of information inherent in the FIV™ cyclic profile

The bottom line is this: The multitude of repeatable features of the cyclic pattern makes it possible to determine the boundaries of the fertile window for every individual menstrual cycle. A key distinction of our technique is that the “dynamic range” of the cyclic profile data (the vertical span) is the same in all cycles and in all women. This – in addition to the repeatable features of the pattern – facilitates electronic interpretation of the data. Only the timing of the various features varies from cycle to cycle, and we work with that.

The cyclic pattern exhibits a number of well-defined peaks and troughs, with the first post-menstruation minimum (or trough, nadir) occurring typically already on cycle day 6, 7 or 8. That’s the selection stage of folliculogenesis (which follows on the stage of recruitment, days 1 – 5). The signal then rises to a maximum (long-term predictive peak, driven by the maturation of the dominant follicle), the highest reading level of the cycle. Over the next several days, the readings fall toward the minimum before the short-term predictive peak. We have found the ovulation-marker minimum after this short-term predictive peak to correlate with urinary LH and FSH peaks (hormones). Based on data, we interpret the ovulation marker to be an instantly detected effect of the steroid hormone switch that occurs at ovulation (estrogen to progesterone regime).

The follicular waves, which occur after ovulation [when the non-pregnant system prepares for the next menstrual cycle], cannot remain in place after conception takes place [the regime change is even more profound]. That is the principle of instant detection of pregnancy.

Should the conceptus be lost to EEM, Early Embryonic Mortality (miscarriage), the follicular waves come back. That’s the principle of early detection of miscarriage also known as spontaneous abortion [SAB], and of detecting and monitoring the return of the non-pregnant system condition.

059q Book of hours

Trying to conceive again should be based on the personal FIV™ [FOLLICULOGENESIS IN VIVO™] data generated by the patient, that is, by the woman trying to conceive. This is a principle of evidence-based medicine. Personalized medicine.

Filed under: 1, biosensor, blog, business, diagnosis, electronic, fertility, health, home-use, in vivo, life science, medical, medical-device, obgyn, pregnancy, reproductive, subfertility, technology, venture, women Tagged: #conceiving, aid, baby, bio-electronic, bioelectrochemistry, biophysical, biosensor, bioZhena, birth, conception, consumer, diagnosis, early-embryonic-mortality, early-pregnancy-loss, EEM, electronic, EPL, family, fertility, follicular-waves, folliculogenesis, health, hormone, infertility, intercourse, investment, medical, miscarriage, NFP, ovulation, Ovulona, pregnancy, reproductive, SAB, spontaneous-abortion, sub-fertility, technology, trying-to-conceive, TTC, Vaclav Kirsner, venture, women's ]]> http://biozhena.wordpress.com/2010/08/25/how-follicular-waves-will-be-used-for-early-detection-of-pregnancy-and-for-early-detection-of-miscarriage-epl-to-ttc-asap/feed/ 1 biozhena Sonography scene. Some contrast vis-à-vis the Ovulona™! Angelo Bronzino - Allegory_of_Happiness The wealth of information inherent in the FIV™ cyclic profile 059q Book of hours http://biozhena.wordpress.com/2010/06/27/about-atrophy-reproductive-aging-and-how-it%e2%80%99s-really-not-nice-to-fool-mother-nature-%e2%80%93-or-with/ http://biozhena.wordpress.com/2010/06/27/about-atrophy-reproductive-aging-and-how-it%e2%80%99s-really-not-nice-to-fool-mother-nature-%e2%80%93-or-with/#comments Mon, 28 Jun 2010 00:50:19 +0000 biozhena http://biozhena.wordpress.com/?p=569 ]]> For people outside of NFP (Natural Family Planning) because NFP people know this already

I have taken it upon myself to popularize Prof. Erik Odeblad’s classic findings about the biophysics of the tissues and secretions of cervix uteri, and how they translate into reproductive physiology and hence to reproductive medicine – at home and in the doctor’s office.

Emeritus Professor Erik Odeblad "The cervix is a precision organ as complex as the eye"

My ulterior motive is that I want to be understood when harking back to the British commercial’s exclamation that warned about too arrogant an attitude towards Mother Nature. Or, maybe I aim at the wisdom of the saying (“It’s not nice to fool Mother Nature!”) to be appreciated particularly within the given field of endeavor and/or endeavour – that is, reproductive management. Even if it were only in a segment of it.

In the Alphabet of bioZhena (which is no Alphabet of Ben Sira, though we model on it somewhat), http://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf , there is an entry about Atrophy and what it does to a woman as time goes on, how “atrophy of mucosal surfaces takes place, accompanied by several problems.”

Jan Amos Komenský (Comenius) Says Farewell to...

In this blog post I focus on aging – and thus atrophy – of the cervix, leaving aside the inevitable corresponding phenomena in other parts of the reproductive system.

Incidentally, the cervix seems to monitor the aging of the ovaries, too, if we are right about the follicular waves and their being a reflection of ovarian reserves and/or the rate of approach of the given female body to menopause. (This could be a nice home-use alternative to the recently announced expectation that the age of menopause will be predicted by blood measurement of the Anti-Mullerian Hormone (AMH), http://to.ly/5ft6 . Or it could be one more option for ovarian reserve testing to complement other tests – and presenting certain advantages.)

The focus on the cervix is due to bioZhena’s focus on the cervix… which in our scheme of things is the supreme monitor of the complex reproductive goings on that Mother Nature designed in order to cope with all that complexity. After you’ve read the Alphabet article on atrophy, you might scroll down to the entry there about the cervix, which will take you also through cervical cancer and cervical mucus, besides a couple of other things cervical. That will or would be a nice preparation for, or introduction to, what follows.

When, at the inception of the project, we decided to focus on the given part of the anatomy, Erik Odeblad’s work logically and inevitably became a part of the background. He used the NMR (nuclear magnetic resonance) technique of physical chemistry to perform the complicated investigation of cervical mucus, and he produced the classical evidence for the difference between the “fertile” mucus macromolecules that allow the passage of the sperm, and the “infertile” cross-linked glycoprotein molecular network that does not. (To this day I remember his usage of “undulations”…)

Reminiscence Archeologique De L'angelus by Salvador Dali

In fact, this early information, which involved the thiol-disulfide (sulphydryl-disulphide) redox couples in the glycoprotein macromolecule, had much to do with our early hypothesis of the mechanism of our measurements. Never mind that his work was in the context of the subjective self-examination used in NFP, which did not work for the female member of the team! Had it worked for her, there would probably not be any Ovulona™ for monitoring folliculogenesis in vivo (FIV™ – which has utility well beyond fertility status determination)!

With atrophy being the general biological aspect of aging (and with the initially very large number of ova or eggs in the young female’s ovaries decreasing as she matures and ages), the cervix similarly “undergoes a natural process of development and aging. The surface area of the cervix that is given over to the mucus secreting glands [“crypts”] gradually diminishes with age.”

Odeblad defines three types of the (endo)cervical glands, which he (and others too ) calls “crypts”:

• S crypts produce S mucus, which forms string-like channels and provides transport (“swimming lanes”) for sperm cells. (“Produces a wet, lubricative sensation at the vulva.” That’s for the NFP sympto-thermal method use, the Billings method and/or the Creighton Model NaProEducation Technology method, the classical NFP or FAM – the latter, Fertility Awareness Method, publicized by Ms. Toni Weschler’s 2002 book Taking Charge of Your Fertility .)

• L crypts produce L mucus, which eliminates low-quality sperm and provides a structure to support what he calls the S and the P mucus. P is a reference to the so-called Peak mucus of NFP or FAM.

• G crypts produce G mucus, which is “an impenetrable gestagenic mucus formed in the lowest cervical crypts. Prevents sperm entry to the cervix and is part of the immune system which protects the woman’s reproductive system from infection.” A remark from dictionary.com: gestagen (jěs’tə-jən, -jěn’) n. A substance, such as a steroid hormone, that affects the uterus in a manner similar to progesterone. And a remark from a scientific commentator: This G mucus is characterized by the oxidized state of the mentioned redox couples, causing cross-linking in the glycoprotein mucin, which prevents microbes including sperm from entering. Visualize this as closed -S—S- gates (as opposed to the open gate form -SH   HS-).

Mondrian_Evolution

There are three fundamental principles at work.

1. Natural baseline aging, and this is fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts, at somewhat different rates: S the fastest, L somewhat slower, G slower still.

2. Slow-down of the aging atrophy by pregnancy.

3. Acceleration of the aging atrophy by the Pill [and/or by other endocrine-active compounds, EACs – this is a logical extrapolation, speculative, but must be assumed].

Now, then.

1. Natural baseline aging, fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts:

“The number of S crypts decreases from teenage. They are first replaced by L crypts starting at the base of the cervix. Later G crypts replace the L crypts.”

Thus, from Odeblad’s graph [rate reckoned from 15 yrs old to 40 yrs old]:

S crypt baseline decrease or diminution (or atrophy) rate:

50% / 25 years = 2% per year.

At 50 years old, S crypts are at some 10%.

Profile of cervical crypts of a baseline woman - never pregnant & never on the Pill

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy or use of the Pill.

This is a baseline profile.

Here is Erik Odeblad’s schematic of the crypts on the surface of the cervical canal:

Carefully mapped lateral wall of the cervix of a 20 year old virgin (reported by Emeritus Professor Erik Odeblad, Department of Medical Biophysics, University of Umeå, S-90187, Umeå, Sweden)

This is Professor Odeblad’s artist’s impression of cervical mucus secretions:

Schematics of cervical mucus secretions

Key to colors:

Blue         = S mucus

Yellow     = L mucus

Red          = G mucus

Green      = P mucus of which there are several sub-types

Pink         = Z granules

Professor Odeblad’s explanatory notes:

Z granules – the enzyme in the Z granules combines with the P mucus to create a liquefying effect.

P mucus – there are a number of sub-types of this mucus, the most relevant for fertility are P2 and P6. P2 could be present as early as the beginning of the fertile phase possibly having a role in liquefying the G mucus. P6 is mostly confined to the upper part of the cervix, occurring close to the Peak of fertility, and having a role in conveying sperm. It creates a very wet and lubricative sensation at the vulva.

F mucus – comes from the cells scattered throughout the length of the cervical canal and has no known special function.

For a recent evidence of four different morphological mucus types, namely L, S, P and G, see “Morphological characterization of different human cervical mucus types using light and scanning electron microscopy” by M. Menárguez, L.M. Pastor and E. Odeblad, Human Reproduction, Vol. 18, No. 9, 1782-1789, September 2003 -  http://humrep.oxfordjournals.org/cgi/content/full/18/9/1782

Citation: “The distribution of crypt zones in the cervix depends on age, number of pregnancies and use of contraception. In a non-pregnant woman, aged 25–30 years and not having used contraception, the cervix averages 22 mm in length and 6 mm in diameter at ovulation. The crypt distribution starting from below and moving upwards is as follows: the G crypts dominate in the lowest 4–5 mm; then there is a zone of L crypts occupying the next 9–10 mm; this is followed by the S zone, for 5–6 mm; and the highest 3–4 mm contains the P crypts .”

When you read the paper, you detect that he has a very special knack for sampling the respective mucus types from the said crypts. Hat off! Work with human subjects is no stroll in the park, to put this mildly.

2. Slow-down of atrophy aging by pregnancy:

Profile of cervical crypts of a 4x pregnant woman

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life with four pregnancies and no use of the Pill.

Pregnancy – S crypt diminution rate from Odeblad’s graph

[4 pregnancies, no Pill, rate reckoned from 15 yrs old to 40 yrs old]:

30% / 25 years = 1.2% per year.

At 50 years old, S crypts are at some 20%.

3. Acceleration of atrophy aging by the Pill [and/or by other endocrine-active compounds, EACs – a logical extrapolation]

Profile of cervical crypts of a woman on the Pill

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy and uses the Pill for 10 years

Pill – S crypt diminution rate from Odeblad’s graph

[no pregnancy, Pill for 10 years (18 to 28 yrs old), rate reckoned from 15 yrs old to 40 yrs old]:

60% / 25 years = 2.4% per year.

At 50 years old, S crypts are at some 5%.

This includes the slow down of the diminution gradient during the last 12 years of no Pill.

Compare this with diminution/atrophy rate during the 10 years on the Pill:

65% – 25% = 40% / 10 years = 4% per year.

This is double the baseline rate of cervical atrophy.

It’s more than 3 times higher than the pregnancy-slowed atrophy rate.

Three concluding remarks by Prof. Odeblad:

“Regression when taking the Pill is different for estrogen-dependent crypts (L and S) and progesterone-dependent crypts (G) which may in part overdevelop.”

“The study of the effects of contraceptive pills on the cervix is a difficult task. A considerable amount of work is required for each patient and the time required spans many years, up to 10 years or more. Many women also want to change to other pills or to other methods of contraception, or perhaps now want to become pregnant. It also happens that some pills are withdrawn from the market. To these difficulties are added the normal age changes in the cervix and the dynamic processes which are of constant occurrence. After 3 and up to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced.” (“Some Notes on the Cervical Crypts”, Dr E. Odeblad, Bulletin of the Ovulation Method Research and Reference Centre of Australia, Vol 24 No 2 June 1997, p31)

Cited and graphics reproduced from http://www.billings-ovulation-method.org.au/act/cervix/ageing.shtml .

“Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural oestrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced. Treatment is difficult.” He also wrote: “After 3 to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced … A pregnancy rejuvenates the cervix by 2-3 years, but for each year the Pill is taken, the cervix ages by an extra year.” Web reference:  http://www.billings-ovulation-method.org.au/act/pill.html .

Comment on implications for contraceptive and other treatments of certain symptoms

For example, the suggested method [Weschler, Toni (2002). Taking Charge of Your Fertility (Revised ed.). New York: HarperCollins. p. 52] of thinning cervical mucus to help achieve pregnancy by taking the OTC expectorant drug guaifenesin, which is thought to act by increasing the volume and reducing the viscosity of secretions.

The drug is also used to treat the symptoms of primary dysmenorrhea [severe uterine pain during menstruation ] where another treatment of choice is combined oral contraceptives [COCs]. Such treatments are administered to adolescents as well as to mature women because dysmenorrhea is a very common and serious problem (25% of women and up to 90% of adolescents ).

In both cases, the expectorant and the contraceptives are administered without knowledge of their mechanism of action in the given problem. Focus is on treating symptoms, not the underlying causes. The patient is the detector of any effect. How does the expectorant drug use correlate with the secretions of the different types of cervical mucus on the one hand, and with the folliculogenesis cyclic profile on the other? Is there any connection? If not, what does the drug do to the different crypts? And what the COCs do to them?

Is the expectorant so selective that it might do the right thing? Reduce type G? Enhance type S mucus? Does oxidation of the guaifenesin help reduce the cross-linked mucin type G in the cervical canal? As simple and pretty as that? (Even prettier if guaifenesin were not to be an EAC, an endocrine-active compound … which inactivity does not look likely – http://www.who.int/ipcs/publications/en/ch3.pdf .)

Would it not be nice to have a rationale for how the small guaifenesin molecule can have a good effect on both sub-fertility/infertility and dysmenorrhea?

Could it be that guaifenesin works bioelectrochemically in the same oxidation-reduction (redox) manner on the enzyme cyclooxygenase in the prostaglandin cascade, which is a cascade of redox reactions – producing an anti-inflammatory effect that translates as suppression of pain? (On a personal note, why not capitalize here at least conceptually on our ancient Wellcome Research Labs work, even before receiving – presumably – the first pension money from Glaxo Smith Kline?)

It’s easier to contemplate in general the effect of the contraceptive drug, which will presumably depend on the contents of the estrogenic and gestagenic components (modeling on Odeblad’s findings)…

Is there a connection between pain, cervix and ovaries, ovarian reserves? Maybe an abnormal depletion of, via ovarian cysts? Will the number of follicular waves and/or other features in the Ovulona cyclic profile – and correlated with ultrasound and MRI – show any such abnormality? Might the Ovulona be useful for diagnosis here, convenient, simple (inexpensive)? Wouldn’t that be nice?

Is cyclooxygenase inhibition detected by the cervix, does it show in the cyclic profile? Does said prostaglandin synthesis inhibition alter the number of follicular waves – while reducing the pain?

Answers to questions like these are needed. Keep in mind that ovulation is an inflammatory process, and since we detect it in the cyclic profile, it is reasonable to pose the above prostaglandin theory questions about the COX-2 (cyclooxygenase) inhibition.

Summarizing Odeblad’s results and the take-home message:

Baseline outcome of cervical S crypts aging: S crypts down to 20% at 40 years of age. Here you have the reason why mature age leads to sub-fertility and to infertility.

Atrophy slow-down effect of 4 pregnancies: S crypts down to 40% at 40 years of age. Here you see Mother Nature’s design in action. Pregnancy slows down the inherent rate of cervical aging (atrophy, deterioration). Naturally, this is not to argue for 4 pregnancies per lifetime – it’s merely how the effect was made measurable.

Atrophy acceleration effect of 10 years on the Pill: S crypts down to 10% at 40 years of age. Here is why it’s not nice to fool Mother Nature, why it’s not good to mess with her design. The Pill is an archetypal anthropogenic Endocrine-Active Compound [man-made EAC], and it was brought up in the previous post how there are very many of these EACs, all insulting the female body and health, some – like chemical contraceptives – by design.

While the story of Laodamia and Protesilao is touching, I merely want to ask that girls, ladies and their physicians do not moon the messenger.

Filed under: 1, blog, business, diagnosis, fertility, health, home-use, in vivo, infertility, life science, medical, obgyn, pregnancy, reproductive, subfertility, technology, venture, women Tagged: aging, Alphabet of bioZhena, atrophy, baby, Billings, biophysical, bioZhena, birth, cervical, cervix, conception, consumer, Creighton Model, CrM, crypts, EACs, endocervix, endocrine-active-compounds, epithelium, FAM, family, fertile mucus, fertility, FertilityAwarenesBasedMethods, FertilityAwarenessMethod, folliculogenesis, gestagenic mucus, health, hormone, infertility, medical, MotherNature, mucin, NaPro, NaturalFamilyPlanning, NFP, NMR, notnicetofoolMotherNature, Odeblad, ovulation, Peak mucus, Pill, pregnancy, reproductive, technology, the Pill, tissue, vaginal, women's ]]> http://biozhena.wordpress.com/2010/06/27/about-atrophy-reproductive-aging-and-how-it%e2%80%99s-really-not-nice-to-fool-mother-nature-%e2%80%93-or-with/feed/ 1 biozhena "the cervix is a precision organ as complex as the eye" Jan Amos Komenský Says Farewell to Karel the Elder of Zerotín, 1873 by Václav Brožík Reminiscence Archeologique De L'angelus by Salvador Dali mondrian_evolution Profile crypts baseline neverprg Cervix of a 20 year old virgin Mucus secretions Profile crypts 4x pregnant Profile crypts on the Pill laodamia http://biozhena.wordpress.com/2010/06/25/more-about-clomid-serophene-clomiphene-citrate-or-clomifene/ http://biozhena.wordpress.com/2010/06/25/more-about-clomid-serophene-clomiphene-citrate-or-clomifene/#comments Sat, 26 Jun 2010 00:28:30 +0000 biozhena http://biozhena.wordpress.com/?p=547 ]]> Why popping pills is not the best. This chemicalization of life is a form of enslavement.

Expanding on the previous post, I reiterate what I left off with. It is advisable – and safer – to go about TTC, Trying To Conceive, without the use of chemicals, especially man-made chemicals – and note that herbal preparations are chemicals too. Monitoring (measuring) the effects of anything [any drug] you ingest is basically a must, if you do not play “Russian roulette” with yourself, your offspring, your family.

There is no such thing as a “magic bullet”, and every drug has side effects. It is advisable – and safer – to go about TTC by mastering the natural “right time” approach. The medical establishment has approved of it for birth control, even if not all medical schools teach it. (Go figure.)

Of course, this is the era of popping pills, but it might also be the tail of the era, if web 2 social networking and all that is really here to stay… (Please don’t say, “you wish” about the tail!) The pressure of big pharma advertizing is what makes for said era. In the Middle Ages, they who were accessible to the then lobbying pressures, had things like the Crusades, witch-hunts, and stuff like that. Now, there are different pressures and more customers accessible to them…

An Angel Leading the Crusaders to Jerusalem - Gustave Doré (1832 - 1883)

But, back to Clomid, clomiphene, now spelled clomifene. This http://www.early-pregnancy-tests.com/clomid.html is one of the many websites about the drug. It warns that “…in the case of clomid and FertilityBlend/FertilAid, the product makers do state that clomid should not be taken with herbal products…”.

Looking at the chemistry of the non-steroidal ovulatory stimulant Clomid (or clomifene), http://to.ly/5dn2, and keeping in mind the inevitable occurrence of metabolic biochemistry (drug transformation in the body of the patient), one finds this title:

Stilbenoids: Resveratrol, Tamoxifen, Diethylstilbestrol, Combretastatin, Pterostilbene, Clomifene, Stilbenoid, Combretastatin A-4, Kobophenol A – at http://to.ly/5dm1.

Simply put, these medicinal compounds are differently substituted stilbenes (http://to.ly/5dQa = chemically modified stilbenes [stilbene being an ethene double bond with phenyl groups on both carbon atoms of the double bond]). Here is the pharma business in a nutshell: The different substituents (or modifiers attached to the stilbene molecule) impart different electronic, electrochemical, biochemical and physiological activities. That’s what the pharmaceutical industry explores in or with their products.

Albrecht Durer - Christ among the Doctors. AD 1506.

Then, we have a search for triphenyl ethylene stilbene http://to.ly/5dkt . Some of the search results are as follows – with particular reference to the fourth one below the recumbent woman (where anthropogenic means “caused or produced by humans”, and endocrine, of course, pertains to an endocrine gland or its secretion into blood or lymph):

OESTROGENS AND PRO-OESTROGENS RELATED TO STILBENE AND TRIPHENYLETHYLENE http://joe.endocrinology-journals.org/cgi/content/abstract/3/1/168 . “It has recently been shown [Emmens, 1941, 1942] that oestrogens may be divided into two classes—those which act directly or with changes that can be effected locally…” (Yes, shown in the forties.)

Estrogens and antiestrogens I: physiology and mechanisms of action …, Volume 1 (1999) http://to.ly/5dkx . “The most prominent drug amongst these compounds is tamoxifen…”

1993: RU 486—A Decade on Today and Tomorrow http://www.nap.edu/openbook.php?record_id=2203&page=71 . “The development of RU 486¹ (Figure B1.1), the first efficient antiprogestin, may be seen as a result…this meeting, which merged science (hormone research) and the cause des femmes… it became clear that the available contraceptive methods did not completely meet the needs of women and their families; nor would they alone have a sufficient demographic impact… Mifepristone (RU 38486)…”

Albrecht Durer - Draughtsman Drawing a Recumbent Woman. 1525. Woodcut.

Chemistry of Natural and Anthropogenic Endocrine-Active Compounds http://to.ly/5dkG . “…endocrine active compounds comprise both naturally occurring substances and man-made chemicals, and their chemical structures are surprisingly diverse… Phytoestrogens, Industrial Chemicals… The stilbene-type agents diethylstilbestrol (DES), E,E-dienestrol and meso-hexestrol were synthesized in the late 1930s and are among the first man-made estrogens used for human treatment… banned today…  The phenolic A ring of steroidal estrogens has long been considered a prerequisite for estrogenicity… also of paramount importance for the high estrogenic activity of DES and other stilbene-type compounds… it has been observed that numerous other phenols exhibit hormonal activity… potential endocrine disruptors, viz., alkylphenols and bisphenols… prototype of bisphenols is bisphenol A (BPA, Fig. 12), used in large amounts for the production of polycarbonate plastics and epoxy resins… Polychlorinated biphenyls (PCBs) are among the most persistent and ubiquitous environmental pollutants. Whereas the PCBs themselves have no or at best marginal estrogenicity, significant hormonal activity may be entailed to these molecules by hydroxylation [22].”

Albrecht Durer - The Martyrdom of the Ten Thousand. AD 1508

To help make some sense of the above, let the editor of Annals of Internal Medicine (http://to.ly/5dnr ) say this: “…in the field of synthetic substitutes for the female sex hormones, the essential point is the establishment of the fact that estrogenic activity is not exclusively a property of compounds structurally similar to the natural hormones [that is, possessing the phenanthrene nucleus]… a number of simpler substances having estrogenic properties…”

So, again, there is no “magic bullet”, there are inevitable side effects, associated with lack of specificity (the scientific term for “no magic bullet”).

Specific Clomid warnings are, for example, at emedzone site (.com/clomid-brand-tabs-aventis-pharma-p-149.html). To cite: The regimen in which Clomid should be used depends on the individual condition… and if HCG was used mid-cycle or not.

Albrecht Durer - The Dresden Altar. AD 1496

Clomid Warnings

Clomid can cause disturbed vision and blurred vision and therefore should be used with caution…

For those women who are planning to get pregnant, be warned that taking Clomid may result [in] multiple births and this may be harmful to the mother and to the fetus as well. (Note: Multiple births are also a very big problem for public health.)

Clomid may also be not advised for patients with the following medical conditions (note: these are conditions that may have caused the difficulty to conceive in the first place):

• Endocrinal disorders

• Thyroid problems

• Live[r] diseases

• Ovarian cysts and enlargement

• Polycystic ovarian syndrome

• Uterine fibroids

• Any other chronic illnesses

• Endometrial carcinoma

• Vaginal bleeding

If you have any of the above-mentioned diseases, your doctor may advise you not to take Clomid or will significantly alter your dosage.

Clomid is also not advised for pregnant women as it is a drug in the pregnancy category X and may cause birth defects when taken by pregnant women.

Clomid is also not advisable for nursing mothers as it passes into the breast milk and may cause harm to the nursing infant. END QUOTE.

Albrecht Durer - Durer's Wife Agnes

In addition, the use of fertility drugs may be associated with an increased chance of developing ovarian cancer, although there is an ongoing controversy over this: http://to.ly/5dmf , http://www.wordiq.com/definition/Ovarian_cancer .

Such are the reasons why popping pills is not the best. Not to attack big pharma, but all this chemicalization of life is a form of enslavement. More insidious than the slavery that was abolished centuries ago, more subtle. First, make them buy a drug that causes such and such side effects including the least spoken of, the premature aging of the cervix http://to.ly/5dMb ; the ensuing problems are then tackled with other drugs (like clomifene), and on and on it goes.

Let’s contemplate with Albrecht’s wife Agnes why it should be that too many pregnancies were the problem before chemical contraception, whereas today… Today, sub-fertility and infertility are on the up and up, while contraceptive failure statistics are in the picture, too, showing that about half of all pregnancies in the U.S. are unplanned, and that mature population of America uses surgical sterilization for birth control.

Last night I re-tweeted this:

RT @FertilAidAmy What is Clomid…? http://blog.fairhavenhealth.com/ =it’s NOT recommended to take [it] for >6 cycles & [it causes] decreased fertile mucus

Then I found that there is no entry about Clomid in the Alphabet of bioZhena. Yet, Clomid is a very frequently administered medication for women with difficulty conceiving, “prescribed to women that are trying-to-conceive to induce ovulation. Clomid is often prescribed to women with irregular cycles that either experience irregular ovulation or don’t ovulate at all” (http://blog.fairhavenhealth.com/ ).

Clomid was also involved in a peculiar episode when a business-incubator director took me once to a local hospital’s young lady gynecologist thinking that, because she was written about in the local newspaper, she was just right for bioZhena Corporation’s quest for good people and/or “strategic allies”. Instead, the take of the young physician, who took several calls from upstairs during the “interview”, was something along the lines, “I don’t see what’s in it for me with your technology. When they [subfertility sufferers] come to us, we put them on Clomid, and that’s that…”.

Dali - Longlegs

Well, let’s look at what the “that’s that” is about. The referenced tweet mentioned, within the allowed 140 characters, two features. One, that Clomid should not be taken for more than 6 menstrual cycles. And two, that it is known to reduce the amount of the all-important “fertile” mucus, which is the cervical mucus form occurring only during the run up to ovulation. This essential temporary change is for the purpose of opening the cervical canal for the penetration of the sperm and, in fact, for what is called the capacitation of the sperm. At all times outside of the fertile window, the “fertile” mucus is replaced by the “protective type of cervical mucus”, which prevents the entry of microbes including sperm into the uterus and beyond.

For a concise overview of this essential mucus, read the article Cervical mucus (under C) in the Alphabet of bioZhena, at  http://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf . There we cite a noted expert on the subject, Dr. Erik Odeblad, and the gist of his message is: “Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural estrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced.”

You can imagine that this will have something to do with the reason why the patient is now prescribed the fertility drug.

One other thing about the drug is the issue of the official “10-per-cent possibility that Clomid could produce twinning”, described by a physician’s blog post at KevinMD.com about “one of the largest malpractice awards in Canadian history. At issue is how the patient understood the discussion of the risks of Clomid”: http://to.ly/5cE7 .

Sublime moment by Salvador Dali

Clomid is the brand name for the fertility drug clomiphene citrate. Clomiphene citrate may also be sold under the brand name Serophene or as the generic version called clomiphene citrate (http://to.ly/5cIc ).

Here is a bit more scientific take on how it works, cited from Wikipedia (http://en.wikipedia.org/wiki/Clomifene ):

Therapeutically, clomiphene is given at day 2 of menses [menstruation]. By that time, FSH level is rising steadily, causing development of a few follicles [in the ovary].

Let’s interject a clarification: This timing is called the recruitment stage of folliculogenesis, during which LH induces an “angiogenesis” factor from the theca cells, increasing the blood supply and estrogen synthesis by the recruited cohort of follicles.

The term “selection” indicates the reduction of the recruited group of follicles down to the species-characteristic ovulatory quota, which in women and related primates is one. Selection is the culmination of recruitment on day 6 ± 1. Typically only one of the two ovaries sponsors recruitment and selection of the single dominant follicle, which is destined for ovulation. We detect the selection stage as the first marker in our ovulographic™ (or folliculogenesis in vivo™) cyclic profile. Refer to the bioZhena tech pitch page http://to.ly/xE6 and to http://to.ly/MJU , http://to.ly/MWl .

Back to the language of the Wikipedia article: Follicles in turn produce the estrogen, which circulates in serum. Clomiphene acts by inhibiting the action of estrogen on the pituitary [gland, or hypophysis, in the brain]. [It] binds to estrogen receptors and stays bound for long periods of time.

This prevents normal receptor recycling and causes an effective reduction in hypothalamic estrogen receptor number. As a result, the body perceives a low level of estrogen… Since estrogen can no longer effectively exert negative feedback on the hypothalamus, GnRH secretion becomes more pulsatile, which results in increased pituitary gonadotropin (FSH, LH) release. Increased FSH level causes growth of more ovarian follicles, and subsequently rupture of follicles resulting in ovulation. END OF QUOTE.

Salvador Dali - Geopoliticus Child Watching the Birth of the New Man

From another Wikipedia article, about GnRH (http://en.wikipedia.org/wiki/GnRH ):

At the pituitary, GnRH [Gonadotropin Releasing Hormone (synthesized and released from neurons within the hypothalamus )] stimulates the synthesis and secretion of the gonadotropins, (that is) follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These processes are controlled by the size and frequency of GnRH pulses, as well as by feedback from androgens and estrogens. Low-frequency GnRH pulses lead to FSH release, whereas high-frequency GnRH pulses stimulate LH release. …the frequency of the pulses varies during the menstrual cycle, and there is a large surge of GnRH just before ovulation.

To reiterate, Clomiphene acts by inhibiting the natural action of estrogen on the pituitary gland in the brain, interfering with – or, shall we say, altering, manipulating – the process of folliculogenesis. Women’s health revolves around folliculogenesis and its complex control mechanism by the brain and by the ovaries.

To give you a sense of said complexity of the biology we are working with when we monitor folliculogenesis in vivo, we cite the specialist, Dr. Ernst Knobil: “The mechanism is believed to involve the circhoral* clock of the hypothalamic GnRH pulse generator, on which the circamensual** ovarian clock is obligatorily dependent”. [*Occurring cyclically about once an hour, pulses from the brain; ** about once a month.] From Knobil’s memorial lecture The Wisdom of the Body Revisited, available online at http://physiologyonline.physiology.org/cgi/content/full/14/1/1 .

During the reproductive years, pulse activity is critical for successful reproductive function as controlled by feedback loops. Cited in conclusion from the Wikipedia GnRH article referenced above. (The Wikipedia also has an article about the cervix and cervical mucus, at http://en.wikipedia.org/wiki/Cervical_mucus#Cervical_mucus .)

15- Word(le) greetings from bioZhena's follicular waves

A wordle is a toy for generating “word clouds” from text.

In this case the entire bioZhena’s Weblog as it was in November 2009 — 15 most prevalent words.

It is advisable – and safer – to go about TTC, Trying To Conceive, without the use of chemicals, especially man-made chemicals, and note that herbal preparations are chemicals too. Monitoring (measuring) the effects of anything you ingest is basically a must, if you do not play “Russian roulette” with yourself, your offspring, your family.

The above wordle, the “greetings from bioZhena’s follicular waves”, is a reminder that, before resorting to the chemical route, the innocuous “right time” approach is indicated (because it does not go against – it goes with – the natural biology of the body).

Have you noticed that the powerful Clomid is an estrogen agonist/antagonist? (Acting like estrogen or against estrogen. Tricky, yes? You bet. Or play roulette…)

Filed under: 1, biosensor, blog, diagnosis, electronic, fertility, health, home-use, in vivo, life science, medical, medical-device, obgyn, pregnancy, reproductive, technology, venture, women Tagged: baby, biosensor, bioZhena, birth, cervical, cervix, cervix uteri, Clomid, Clomifene, Clomifert, clomiphene citrate, conception, consumer, diagnosis, electronic, family, fertility, folliculogenesis, FSH, GnRH, gonadotropins, health, hormone, infertility, intercourse, Knobil, LH, medical, mucus, NFP, Odeblad, ovarian stimulation, ovulation, pregnancy, reproductive, Selective Estrogen Receptor Modulator, SERM, Serophene, subfertility, technology, timing, tissue, twinning, vaginal, venture, women's ]]> http://biozhena.wordpress.com/2010/06/23/about-clomid-serophene-or-generically-clomiphene-citrate/feed/ 0 biozhena 30% of women or couples cannot get pregnant dali - longlegs_large 10098591 sublime moment by Salvador Dali, 1938 Dali - Geopoliticus Child Watching the Birth of the New Man (1943) Sleep by Salvador Dali, 1937 15- Word(le) greetings from bioZhena's follicular waves http://biozhena.wordpress.com/2010/06/20/comment-on-female-sexual-dysfunction-treatment-options/ http://biozhena.wordpress.com/2010/06/20/comment-on-female-sexual-dysfunction-treatment-options/#comments Mon, 21 Jun 2010 05:25:48 +0000 biozhena http://biozhena.wordpress.com/?p=466 ]]> An excellent overview post appeared on the KevinMD.com blog, titled Female sexual dysfunction treatment options, written by Jill of All Trades, MD: http://www.kevinmd.com/blog/2010/05/female-sexual-dysfunction-treatment-options.html .

It is worthwhile to capture the introductory paragraphs of Jill’s post here:

Female sexual dysfunction has been reported in up to 40% of women, and described as causing actual distress in approximately 12% of women.

Michelangelo, The Last Judgment, 2 cropped

Therefore, it is an important topic to familiarize with and screen for as a primary care physician, as many patients may not report these symptoms unless they are elicited during the history taking process of the patient encounter. Female sexual dysfunction is often multifactorial and complex; it is affected by such factors as depression and anxiety disorders, life stressors, interpersonal conflict between the couple, medication side effects, age, religious concerns, personal health, privacy issues, personal body image, substance and alcohol abuse, and hormonal influences.

In order to understand the necessary treatment options, it is important to understand the normal female sexual cycle. There are four phases:

1. Libido: the desire for sexual intimacy, through images or thoughts.

2. Arousal: the increase in heart rate, blood pressure, and respiratory rate, along with increased genital blood flow.

3. Orgasm: the peak of sexual pleasure, with rhythmic contractions of the pelvic muscles.

4. Resolution: the return to baseline with pelvic muscle relaxation.

Michelangelo The Last Judgment

The author then very nicely and concisely reviews the treatment options.

I posted the following comment, which at this writing was “awaiting moderation”. -

Thank you for an excellent overview.

I envisage that our Ovulona™ personal vaginal monitor (http://biozhena.wordpress.com/2007/12/11/the-ovulona™ ) will do two useful things for peri-menopausal women and their physicians (http://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ):

#1. Detect effect of any treatment on vaginal tissues and thus allow for personalization of therapy, titration of medications); and

#2. Allow vaginal delivery of therapeutic compounds.

The Ovulona should become a friendly companion tool for all women, to be routinely used from adolescence to peri-menopause (not only for reproductive management, its primary – or certainly initial – purpose).

Ref.: http://biozhena.wordpress.com/2007/12/18/menopause-hrt-and-biozhena/

Regards,

@bioZhena

Michelangelo, The Last Judgment, 2

To this, for the purpose of the bioZhena’s Weblog, I would add a reminder about the significance of the problem of (tissue) atrophy, which the reader will find in The Alphabet of bioZhena (under A in the article titled Atrophy) at http://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

Atrophy means a wasting away, deterioration, or diminution, any weakening or degeneration (especially through lack of use). Read the article, you’ll see about genitourinary atrophy that leads to a variety of symptoms (in both sexes), affecting the quality of life.

And more, including about “estrogen therapy, which is invariably successful in reversing the atrophic problems. Relief from these problems often results in significant improvements in general well-being.”

In my comment above, #1 (detect the effect of treatment on vaginal tissues), the need for personalization of estrogen therapy is reflected, which requires the end-organ effect measuring tool that we provide. See also under E for End-organ effect in the Alphabet of bioZhena.

STOP PRESS

In case you are interested in our Ovulona Fertility Monitor, let me suggest that you look into a proposition whereby you can secure a substantial discount on your future Ovulona by promising to prepay at least a portion of the price. Since the project has set a goal period of 90 days, the proposition will not stay open longer than after the Valentine’s Day (90 days from November 26, 2011). Do check it out, and see that it is a win – win, at  http://www.fundageek.com/Project/Detail/237  .

“High-risk pregnancies are more likely in women who have difficulty getting pregnant, with or without help from hi-tech fertility treatments.”

Read more about this in the article from which this is cited, at: http://doctor.ndtv.com/storypage/ndtv/id/004480/type/news/Difficult_conception_tied_to_pregnancy_complications.html

In a nutshell, the article reports the outcome of an Australian analysis of the pregnancies of more than 2,000 subfertile women who sought A.R.T. fertility treatment between 1991 and 2001. The outcome is that these women were more likely to have pregnancy complications than a control group of twice as many women who became pregnant and “gave birth without using any assisted reproductive technique”.

The article gives as examples of complications higher incidence of pre-eclampsia (a potentially dangerous condition, marked by high blood pressure and protein in the urine) and of cesarian sections, premature births and low birth weight babies, and even higher infant mortality.

The article cites as the source an unspecified publication in the highly respected journal called Fertility and Sterility, in April 2010, which source could not be found by this writer.

However, whatever the details of the actual study, it is perfectly logical to highlight the important attributes of our Ovulona™ technology in this context. The Ovulona is uniquely well positioned to assist, including the management of the early-stage pregnancies associated with subfertility and infertility.

Our Ovulona™ addresses this, unlike any other conceptive-aid diagnostic device

The Ovulona FIV™ technology is unlike the various other conceptive-aid products (aka ovulation predictor kits and similar fertility self-help products) available in the marketplace today. This is not only because of the unprecedented accuracy of determining the 3-days of the fertile window, which no other technique but our Folliculogenesis In Vivo™ (FIV™) technology can offer. The other conceptive aids assume (but do not determine the boundaries of) a wider fertile window, and they merely assume ovulation without actually detecting it (because their techniques cannot detect it, and because detecting ovulation clinically is complicated and expensive).

That’s also why medical scientists have had difficulties with determining the fertile window. However, an otherwise very well designed 1992 study in Auckland, New Zealand showed the three days of the fertile window: 77% boys born on day 1 of the fertile window, 69% girls born on fertile day 3 (ovulation), and in between on day 2 of the fertile window, 70% boys and 30% girls. The 3-day fertile window was also evident in the data of a less well designed 1995 study that came out of the NIH. Both studies suffered from the use of inaccurate methods of estimating ovulation, resulting in data outliers that they interpreted as a fertile window wider than 3 days – with much lower pregnancy rates on the flanks of said 3 days. 6 days has been in the public mind since the 1995 study that caused a sensation at the time (because 6 is much better than the previously believed 10 or even 13 or 14) – and the problems with achieving pregnancy have continued to this day.

An earlier post in this blog summarized this as follows [ http://biozhena.wordpress.com/2010/03/23/critique-of-birth-control-efficacies-in-nfp-as-published-by-marquette-university-researchers ]:

The old approaches to detecting fertility status are to be referred to as peri-ovulation methods. Where the prefix refers not to the Peri of Persian folklore (earlier regarded as malevolent!) but to the Greek meaning of about, around, near or enclosing – in this case ovulation. Surely, peri-ovulation or peri-ovulatory is a more palatable word than fuzzy.

STOP PRESS

In case you are interested in our Ovulona Fertility Monitor, let me suggest that you look into a proposition whereby you can secure a substantial discount on your future Ovulona by promising to prepay at least a portion of the price. Since the project has set a goal period of 90 days, the proposition will not stay open longer than after the Valentine’s Day (90 days from November 26, 2011). Do check it out, and see that it is a win – win, at  http://www.fundageek.com/Project/Detail/237  .

In the context of the tie up between conception difficulties and pregnancy complications, the Ovulona FIV advantage is this threesome – if “advantage” is even the right word. It really is a must.

Bronzino - Allegory of Venus

The three things needed by a woman experiencing difficulty to conceive are:

1. Know from your underlying folliculogenesis profile in the present menstrual cycle when exactly your 3 days of the fertile window occur.

2. Know within a couple of days after the detected ovulation whether your conceptive intercourse (intended to conceive) did or did not result in conception.

3. Know whether the early stage of pregnancy progresses well or not.

While numbers 2 and 3 are yet to be elaborated by bioZhena, contingent upon funding, they are inherent in the principle of the FIV technique, discussed throughout the bioZhena’s Weblog.

Allegory of Music by Francois Boucher

The above referenced publication was nowhere to be found in Fertility and Sterility issues of the last three months. But, one of the pertinent papers we did come across there revealed, based on a survey of several hundred female undergraduates at a North American university: “Although most women were aware that fertility declines with age, they significantly overestimated the chance of pregnancy at all ages and were not conscious of the steep rate of fertility decline. Surprisingly, women overestimated the chance of pregnancy loss at all ages, but did not generally identify a woman’s age as the strongest risk factor for miscarriage.” The paper concluded: “Education regarding the rate at which reproductive capacity declines with age is necessary to avoid unintended childlessness among female academics and professionals” [Fertility and Sterility, Volume 93, Issue 7, 1 May 2010, Pages 2162-2168].

The above-reported overestimating of the chance of pregnancy – and by the same token also the predicament of people seeking to achieve pregnancy – can (perhaps!) be understood in light of the following statistical factors.  Any woman has a 90% chance to be healthy at the time the sexual intercourse is occurring; the fertilization rate could then be intuited to average also 90%.  But it does not because of inherent 25% loss to early embryonic mortality or miscarriage, abortion [EEM], so that a successfully inseminated healthy female has only a 75% chance of successful pregnancy.

As a consequence, the probability of becoming pregnant is critically dependent on whether the insemination (natural or artificial) occurs at the right time (the so-called fertile window).

Here is how critical this timing is for healthy women: Even if the probability of determining the insemination time correctly were 90%, the resulting probability of successful pregnancy from any one particular insemination event would be only 55%.  Get this! Only 55% under perfect conditions. This is because the probability of pregnancy is the combination of four individual probabilities:  90% x 90% x 75% x 90% = 55%.

That is the probabilities of being in good health, of successful insemination, of not miscarrying the conceptus, and the probability of correct timing of the conceptive intercourse. Thus:

P-health x P-fertilization x P-non-abort x P-insemination timing = P-pregnancy

For example, a 60% success rate of correct timing brings the overall rate of pregnancy down to a mere 36%, and this goes down to a mere 30% if correct timing probability is only 50%, in healthy fertile couples.

But then, even a quick search for data on EEM (Early Embryonic Mortality] suggests that human EEM is likely much higher than the above-considered 25%, possibly even as high as about 83% (“only one embryo in six survives to term”), and certainly appears likely around 50% in healthy women. Hence the probability of pregnancy is lowered from the approximate 36% or 30%, and it can be much lower if the timing is off, if the probability of correct insemination timing is low.

Examples – Probability of pregnancy as a product of four probabilities:

Pertaining to the health factor, another study published in the same specialist journal showed that women who were obese adolescents had significantly higher odds of remaining childless compared with normal weight women [ Fertility and Sterility, Volume 93, Issue 6, April 2010, Pages 2004-2011].

Childlessness is one thing, and the enormous responsibility that women carry on their shoulders is another. That is, responsibility for the health of the as yet unborn children. Like it or not, a woman’s health and lifestyle both have significant consequences for the offspring.

Alfons Mucha - Job

Cigarettes are a big huge problem, causing harm to your unborn, and that’s smoking at any time, not just in pregnancy. Premature births, a big huge problem with serious consequences. Difficult births requiring the use of forceps, the pincer-like tool they might use to pry the baby’s head out of you with – that, surely, the baby could do without, if only the birth were not difficult… These are just a few examples highlighting the major responsibility of womankind for the health of humankind.

The FIV™-monitoring Ovulona™ is superior compared to existing commercial products in the home-use fertility self-help category, such as the urinalysis hormone (LH) kits or OPKs and their improved electronic iteration, and other such products. Superior on several levels.

Unprecedented user-friendly design coupled with unprecedented accuracy, liberating the user from the vagaries of imperfect ovulation method-based probabilities.

That must be the main one for the TTC [Trying To Conceive] people, but additional attributes are no less significant. Multi-purpose applicability including but not limited to built-in early pregnancy detection and early pregnancy monitoring. That’s to help manage and deal with the inherently high prevalence of early embryonic mortality [EEM], the chief complication of human gestation. (See http://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection .)

When the TTC hurdle is successfully dealt with, the EEM is the next obstacle on the way to overcoming the sub-fertility issue. Just think about this for a moment. The EEM is Mother Nature’s design to deal with problems that quite likely lead to the TTC challenge (aka sub-fertility or even infertility) in the first place…

There is more to the superior attributes of the FIV technology [FIV = Folliculogenesis In Vivo]. Readily thought about is non-invasive natural birth control. The Ovulona is an electronic tool for 21st Century’s NFP and/or FAM. Natural Family Planning and Fertility Awareness Method, both of which we envision under the umbrella of Scientific Family Planning™, SFP™.

Furthermore, once you become aware of how Folliculogenesis In Vivo works, it will be less of a surprise to see that the Ovulona tissue biosensor will also provide a nice and easy cervical cancer screen – and prospectively screening for other pathologies, and their treatment…

Treatment (as opposed to diagnosis), you wonder what that is about? It’s about the vaginal tissues being the most efficient route for administration of medications, and very logical for a topical treatment, wouldn’t you think? Logical and potentially pretty effective for public health, once the tool has become widely used due to its affordability and mass-market acceptance. That’s the vision.

Of course, there are still other applications that the male managers of investment coffers tend to view as women’s issues that are not their concern, such as management of PMS and its debilitating form the PMDD, such as proper evaluation of EDD and EDC (Expected Date of Delivery, and of Confinement), such as hormone therapy and related matters. All these are big issues of public health, the sentiments of said managers of other people’s money notwithstanding.

Now, back to the primary and initial use of the FIV-tracking Ovulona.

Only the Ovulona can determine the three days of the fertile window of opportunity to conceive, unperturbed by the talk out there – by the proponents of the imperfect ovulation measures – about six days, which talk stems from a certain highly publicized and yet flawed study in 1995… A publication (in NEJM) that caused a sensation at the time by shortening the NFP’s prescribed period of abstinence from the previous too long imposition to the less off-putting 6 days).

Detection of the 3 fertile days is possible because the Ovulona monitors the process of folliculogenesis, and it does it by sensing the tissues in the reproductive tract where the site of action is. Where the body integrates and responds to signals from the ovary and from the brain. That is the action, as opposed to the presence of this or that hormone in blood or urine or any other body fluid.

The determination of the three days window is absolutely necessary because only that way can conception be either assisted or avoided with the required accuracy. The existing home-use fertility tracking commercial products cannot do that, and that is why they speak about a longer and fuzzy fertile window. See preceding and older posts in this blog if you want to get a better understanding of all that which is covered by the short word fuzzy. You will also get the long word (peri-ovulation methods) if you delve into the matter that way.

The existing commercial products cannot be used, either, for an attempt at baby gender pre-selection by timing conception with respect to ovulation. They cannot do that because they do not anticipate ovulation accurately and they do not detect ovulation (they merely assume its occurrence).

Joan Miro - Birth World

Consequently, those techniques cannot distinguish between 2 or 3 days before and the day of ovulation. This is to try for a boy or for a girl, respectively, or to TTC, or to avoid conception. The commercially available technologies do not detect ovulation independently of the one predictive element they test for – or two such elements, LH and E2, in the case of the urine-analyzing gadget now sold by Inverness/SPD GmbH. It is not unlike groping in the dark… The other electronic gadget out there, the one offered by Zetek, is tracking indirectly the effect of the same hormone (estrogen) in two body fluids with two probes at two different times during the menstrual cycle. And your old BBT method tracks indirectly the effect of progesterone that you know causes the BBT to go up a bit after ovulation, albeit with a statistical uncertainty of + or – 3 days (and a poor signal to noise ratio at that).

The thing that the old *Imperfect Measures* tools detect is an input in the hormone signaling mechanism they talk about but of which mechanism they monitor merely that one input hormone signal (or two). However, the boundaries of the fertile window are not single hormone events; hormone monitoring (direct or indirect) cannot define the fertile window.

The existing products do not determine the fertile window of 3 days because they monitor this or that remote parameter that only reflects some aspect of the process that culminates in ovulation. They only detect a hormone signal that says “ovulation can happen about now” (LH), or a signal that says “ovulation has occurred” (BBT); or some reflect estrogen (e.g., through saliva appearance). Estrogen elevates before LH but not far enough ahead, and certainly it does not indicate the start of the fertile window nor the end of the window, which is ovulation. A saliva property is a fuzzy detector of estrogen, much like the vaginal fluid’s tactile and visual examination practiced in some circles.

Clock Explosion by Salvador Dali

Significantly, the hormones that anticipate ovulation do not mean that ovulation occurs right away or even at all. They just signal that the body is ready. It is essential to actually detect the occurrence of ovulation independently of prediction, and only our technology does that. Stress often either delays or even prevents ovulation, and only the Ovulona™ detects this. You can again find some earlier posts with more details about this.

There are also earlier posts about the variability of ovulation times from cycle to cycle in the same woman (as well as across a population), and the variability can be more than the width of the fertile window, more than the said 3 days. That 3 day span tends to also be the statistical uncertainty of the old techniques referenced here, plus or minus 3 days.

Serious consequences ensue for the users of the old *Imperfect Measures* techniques, whether employed to achieve pregnancy or to avoid it. Look at the small example from a small test-of-concept study by an independent NFP research-and-teaching group.

In the four recorded cycles of a childless 41-years old patient, the Ovulona prototype captured 3 delayed ovulations out of the 4 recorded cycles. In only one of the four cycles did the LH agreed with our ovulation marker while Peak Mucus indication was one day late in that cycle. In the three cycles with delayed ovulation, the delays were:

In cycle 1, 4 days after LH kit positive and 3 days after Peak Mucus.

In cycle 3, 3 days after LH kit positive and 2 days after Peak Mucus.

In cycle 4, 1 day after LH kit positive and 2 days after Peak Mucus.

In another post in this blog, we showed how the test data divides the NFP clinic patients’ results into two categories that we termed regular and irregular (challenged). To avoid confusion with the traditional usage of the term regular/irregular in the context of menstrual cycles, we shall refer to the two categories as ordinary and challenged, respectively. Cycle 2 is an ordinary cycle (with LH and Peak mucus within 1 day of ovulation marker day) versus the other records showing challenged cycles with delayed ovulation.

The other challenged cycles from the study are tabulated below here, and you will note that they are quite numerous even in the small study of just 10 women with 2 cycle records each. Even in that small population of real life women, 45% cycles were challenged. You also see that the ovulation delays occur at any age (here from 19 to 41 years of age), and regardless of parity (that is, regardless of whether the woman has ever borne children or not):

In the table of ovulation days indicated by the three techniques, O stands for the ovulation marker of Ovulona prototype, LH means LH kit (OPK) positive result, and Pk means Peak Mucus result (as taught by NFP teachers).

As noted above, LH and Pk are in all these cycles lower than the O values, which relationship defines the category of challenged cycles (ovulation delayed with respect to given hormone signal). The delays in this small sample from a small pilot study are from 2 days to 4 days with respect to LH, and from 2 to 3 days with respect to Pk; two cycles are without any LH surge detection.

We also note that our self-diagnostic process – while generating the detailed folliculogenesis profile data for optional analysis by the woman’s healthcare provider – is not unpleasant as is urine sampling, and is not cumbersome, confusing or prone to subjective misinterpretation of results as the other technologies tend to be.

We can and we do envisage the Ovulona to become a friendly routine for the women of the 21st century, everywhere. The existing home-use fertility monitoring products could not aspire to play that role. Hormones in body fluids are only of temporary utility for TTC. Against that, FIV (or Folliculogenesis In Vivo) is not only a superior tool for TTC but it goes beyond that first use – to be of unprecedented and unique service in personalized women’s healthcare for years to come.

See earlier posts in this blog about how symptoms (such as PMS symptoms) vary depending on the day of cycle and on the health conditions of any woman. It is known that female patients respond to therapy differently in relation to their menstrual cycle, i.e., in relation to folliculogenesis. That relationship to the FIV profile is THE fundamental guiding principle of personalized medicine for women.

A new era of obstetrics and gynecology in the offing.

Folliculogenesis in vivo for women's healthcare - the vision (from Space perspective, courtesy of NASA)

Yes, dear, contingent upon funding…

JUST LIKE THEIR PREVIOUS REPORT IN 2003 [http://www.nccbuscc.org/prolife/issues/nfp/cmrsumfl01.htm ] OF A STUDY WITH THE PERSONA MONITOR, “LIMITATIONS” OF THE TWO STUDIES THEY REPORT ON ARE POINTED OUT BY THE AUTHORS.

Michelangelo - The Drunkenness of Noah

Excerpts from their first study:

The retrospective study involved 204 couples (i.e., women with a mean age of 28.6 and their male partners, with a mean age of 30.3) who were taught NFP (by health professionals, physicians and nurses) at four sites in the United States

Table 1. Twelve months total unintended pregnancy rate [number of unintended pregnancies out of the number of couples in given group using the indicated method of NFP]

BBT + mucus                                    5/76                     7%

Monitor + mucus                               4/69                     6%

Mucus only                                       1/29                      3%

BBT + mucus + monitor                     2/25                      8%

Monitor only                                      0/5

Second study excerpts:

The participants for this study came from the same four clinic sites as the previous study and involved 313 couples who were taught how to avoid pregnancy with the EHFM [Monitor] plus CVM [Mucus], and another 315 who used CVM only … The researchers found a total of 28 unintended pregnancies with the EFHM plus CVM group and 41 with the CVM only group… (during 12 months of use)

Monitor + mucus                          28/313                        9%

Mucus only                                  41/315                        13%

QUOTE: “both studies have limitations in that they were not randomized clinical trials”.

In their 2003 study report, they similarly noted study limitations, but there was also the following: “Of interest is the authors’ statement that only 1% of reproductive age women in the Netherlands use NFP as a means to achieve or avoid pregnancy. The respondents in this study were mostly women who previously used oral hormonal contraception. This seems to indicate that a new technological device such as Persona could attract new couples to use NFP.” QUOTE UNQUOTE.

Quite right. Their statement of what “this seems to indicate” is consistent with what we had found (without any financial backing by a large investor like Unilever) in a survey of 5,000 American women at about the time when the Persona was new to the market in Britain. Out of those who would purchase our self-diagnostic electronic device (which does NOT require any chemical reagents and daily peeing for in vitro diagnostic measurement with imperfect measures), 70% were users of artificial contraception – they would switch to our device. This outcome was separate from anecdotal evidence of numerous letters and later emails asking if they could purchase our device for their use in NFP.

With the above quote in mind, we would broaden the conclusion – about new technology attracting new couples – beyond NFP use, and we would refer instead (i.e. more broadly) to fertility awareness based methods.

Are you interested in our superior Ovulona™ monitor? For your 3-day fertile window? See STOP PRESS, below.

Now, before someone should glance at the above reported outcomes of the two studies and quickly jump to a conclusion, we must make some common sense observations about those statistics. Some little words.

Kandinsky - Little Words

Should someone want to declare that the above Marquette University reported Monitor had a zero failure rate, then it must be noted that, unfortunately, this was zero out of merely 5 cases. Not comparable with anything else in their publication – and hardly very useful for that reason (and because of the small sample size, too).

Similarly: Table 1 might be read as showing that mucus only is better than BBT + mucus + monitor. This could be “legitimately” considered a valid conclusion since the sample sizes are sort of comparable – if “sort of comparable” were considered good enough (76 and 69, respectively, a 10% difference). But the sample size of mucus only (29) is significantly lower than the sample sizes of the BBT + mucus and of the Monitor + mucus groups.

While the unintended pregnancy outcome of the BBT + mucus + monitor group (8%) is sort of comparable to the outcomes of the two groups with the much larger sample sizes where mucus is accompanied by either BBT or by monitor (7% and 6%, respectively), the only really legitimate conclusion or comment is that sample size matters. That is, if we do not want to compare 25 apples with 72.5 oranges (+/- 3.5) and thus come to questionable conclusions.

If all the groups had sample size of 5 and the percentage outcomes were the same, then the conclusion would be fairly legitimate about the superiority of the monitor – except for the equally legitimate complaint that the sample size of 5 is too small.

Michelangelo - The Battle of Cascina

Statistics are supposed to be about large numbers. At least about sufficiently large numbers. Sample size of 5 is hardly sufficiently large, although it would do for a proof of concept, which here the concept would be that Monitor alone is by far the best. I would go with that hypothesis BUT I WANT IT TESTED RIGOROUSLY IN PROPERLY DESIGNED CLINICAL TRIALS.

The outcomes of the second reported study contradict the outcomes of the first, with Mucus only now showing the highest failure rate of them all (13%), and, topping it off, Monitor + mucus is now even higher than in Table 1 (9% vs. 6%).

Since the sample size is now much larger than in Table 1 (313 vs. 69, i.e., 4.5 times larger) it is legitimately concluded that the second study carries more weight and therefore the failure rate of the Monitor + mucus methodology is more likely 9% than 6%. This is rather unsatisfactory but still better than Mucus alone at the whopping 13% unintended pregnancy rate. The 13% failure rate with 315 couples is more believable than the 3% failure rate with 29 couples in Table 1. About 10.862068965517241379310344827586 more believable – to be light-hearted about it, per jocum dixi.

Then again, remotum joco: All this makes for a kind of arithmetic that should not occur in medical research.

The following is a graphical demonstration of how numbers can distort perception and understanding. The same Michelangelo’s Battle of Cascina (since he did not do any battle of statistics or technologies!) after an effect that allows the data on the periphery to dominate or simply affect disproportionally that which was in the center of focus.

See in the picture above the man looking intently toward us from the middle of the melee? Now (below) he is tiny compared to what’s around him; much like when – in a study of birth distributions as a function of the day of cycle on which conception took place – the data point outliers are doing the same to the high birth counts, because of inaccurate means of ovulation detection (actually mere estimations) employed in said study.

Michelangelo - The Battle of Cascina - Fish Eye effect -30

While such distortions happen with all imperfect measures of ovulation, the study by John France et al. was discussed in an earlier post at http://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ and in the document attached to that post, http://biozhena.files.wordpress.com/2007/12/fetal-sex-preselection-illustrated.pdf .

We subsequently showed, in http://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit/, the effect of doing away with the outlier data points by means of the following diagram, which can be likened to removing the Fish Eye Effect -30 from the distorted Michelangelo picture just above to get back his undistorted Battle of Cascina (with all those naked Florentine soldiers surprised by the enemy while bathing).

Ovulona 3-day fertile window versus old methods' fuzzy estimation of the fertile period

Now, one more citation from the paper under discussion. QUOTE: The EHFM [Monitor] is a hand held device that reads a threshold level of urinary metabolites of estrogen (estrone 3 glucuronide) and luteinizing hormone (LH; on test strips) and provides the user with a low, high, and peak reading of fertility. The monitor is sold in the United States as a method to help couples achieve pregnancy but can be used as an aid to track fertility. QUOTE UNQUOTE

This statement reflects the thinking in those circles. But note: Because no single hormone determines the beginning and no single hormone determines the end of the fertile window (whether they know this or not) they have to speak of low, high and “peak reading of fertility”. We have previously referred to this as a fuzzy delineation of the fertile window [http://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ].

A little bit fertile, then more, and a peak? That is merely a reflection of not having the accuracy to determine the boundaries of the fertile phase.

Salvador Dali - Metamorphosis of Narcissus

Just like you cannot be only a little bit pregnant, you either can conceive today or not. No such thing as low fertility, only the uncertainty of “low reading”, and of all their readings – including their subjective self-observations. Subjective self-observations refer to the mucus appearance and feel in NFP practice – and if they used that too, the same limitation applies to palpating the cervix.

The most succinct word about all this is as follows:

The old approaches to detecting fertility status are to be referred to as peri-ovulation methods. Where the prefix refers not to the Peri of Persian folklore (earlier regarded as malevolent!) but to the Greek meaning of about, around, near or enclosing – in this case ovulation. Surely, peri-ovulation or peri-ovulatory is a more palatable word than fuzzy.

STOP PRESS

In case you are interested in our Ovulona Fertility Monitor, let me suggest that you look into a proposition whereby you can secure a substantial discount on your future Ovulona by promising to prepay at least a portion of the price. Since the project has set a goal period of 90 days, the proposition will not stay open longer than after the Valentine’s Day (90 days from December 1, 2011). Do check it out, and see that it is a win – win, at  http://www.fundageek.com/Project/Detail/237  . 

We all know that the peri in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology…”. We know that “peri” is in fact a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek, such as in the title here [http://dictionary.reference.com/browse/peri].

Peri - 1865

And now for the last few tweets; again somewhat edited, since here we do not have the 140 character limit. And again with clickable links to further information, including the #hash tags with all sorts of tweets there by anybody using a given hash tag, in the manner of the Twitter social networking mechanism.

These tweets should do it for this departure into the so-called microblogging. Do check out http://to.ly/VCF for what a reliable #fertility tool is about. Read up on it http://to.ly/vUz

Here is a birth control product that will be in the competition category when we go into the birth control market: http://twitpic.com/1971ez – This is the device used to insert the ‘Mirena’ coil into the patient’s uterus. Sent via TwitPic. Retweeted by you and 1 other. The reason why this was re-tweeted by yours truly was to highlight the invasiveness of the pictured device, which bears no comparison with ours (quite apart from our device not inserting into the uterus). But, of course, our product is not out yet, with all its user-friendly and otherwise beneficial attributes. Any comments, dear reader, would be appreciated.

RT@pregnancyorg: Read about your cycles getting #pregnant before #conceiving http://ow.ly/1l765 — and then I suggest you also read http://to.ly/VCF and http://to.ly/vUz

RT@Averyugya81: ARTs [Artificial Reproductive Technologies] for #infertility treatment may pass on genetic defects – warns ART pioneer http://to.ly/1pOJ . This is reminiscent of the development when Father of the Pill Dr. Djerassi turned against oral contraception, promoting instead what he called “the Jet-Age Rhythm Method”, by which he meant fertility awareness (aided by technology, hence the reference to jet age)

RT@Averyugya81: How often do I have to have sex to get #pregnant? http://to.ly/1pPi

How often?

- Every day for 20 days with 69% chance of success, write statisticians http://to.ly/1phs (from day x to day y of your cycle)

If this continues to be pleasuresome, carry on for months on end to overcome the odds. Else, you need focus, and see my earlier tweets. Fight statistics! (With pleasuresome determination and with the aid of a deterministic timing tool… in the offing)

Again: The odds are against us! #pregnancy #birth control #fertility #startup angel-investor-find-and-match… same difference! Odds are very low (without that focus)

@pregnancyorg‘s gender selection http://to.ly/1qkx seems to perpetuate the Shettles recipe. However, evidence http://to.ly/1nyK http://to.ly/1qmz contradicts Shettles (whose claims have the reputation of not being backed by or based on any properly designed clinical studies). Here is a summary of a solid study, which – for the lack of “Perfect” – employed three “Imperfect Measures” of ovulation as defined in the previous post. The three gave similar results. Female births at (or near) ovulation, male births 2 days earlier (or so)

Birth distribution by gender - France et al., focused NFP TTC study

The uncertainty expressed by the “or near” and “or so” is the consequence of the “Imperfect Measures”, but the trend is clear. Also rather clear is that the low birth counts flanking the high ones are data outliers due to measurement errors inherent in “Imperfect Measures”. For more on this, go to the earlier post at http://biozhena.wordpress.com/2007/12/15/fetal-sex-pre-selection-%E2%80%93-the-fundamentals

Baby gender pre-selection will require a clinical study as stringent as the France et al. study was, but performed with our Ovulona instead of the inaccurate methods (BBT, Peak mucus, LH rise as opposed to LH surge apex)

Delville - Satan Treasures, 1895

RT@BabyMed: So can you get pregnant from having sex on your period? http://bit.ly/29yLQJ — THE absolute requirement is a RELIABLE #fertility monitor. (Persistent monitoring in the interest of evidence-based medicine)

RT@BabyMed: So can you get pregnant from having sex on your period? Yes, but only if the cycle is very short, which would be due to a very short follicular phase, which you can only detect with a RELIABLE monitor. (Not to track merely one, two or even three hormones in body fluids – you need to follow FIV™, Folliculogenesis In Vivo™)

RT@bioZhena RT@BabyMed: Furthermore, you want our built-in #pregnancy detection because it will see you #pregnant right away (not only about two weeks later), and – importantly – our device will also see if the pregnancy is lost, which happens quite frequently. See  http://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection . Early embryonic mortality is very high (according to some sources significantly more than 50%), and most of the losses of the conceptus occur early on, prior to 12 weeks. Mostly they occur sub-clinically, without the knowledge of the mother (by one expert source, 52% of all women who conceive experience early miscarriage…)             

RT@bioZhena: RT@BabyMed: Can #pregnancy result from sex on period? Yes, if it’s a very short cycle (due to a very short follicular phase) – which is unlikely – as the pre #ovulation phase is rarely that short. Since teenage cycles tend to be irregular and often short, this is of particular interest to sexually-active teens.  You must MONITOR your cycles if you don’t want any such surprise

RT@bioZhena: RT@BabyMed: Can #pregnancy result from sex on period? See here how unlikely it appears http://to.ly/1k9L . Unlikely, if the shortest follicular phase is 6 days. Menstrual bleeding would have to be as close to ovulation as 4 days, to make the answer unequivocally positive; that would mean cycle length of 18 days (or 16 to 20 days). Very rapid dominant follicle maturation. Until this (shortest follicular phase question) is investigated with our Ovulona monitor of Folliculogenesis In Vivo™ [FIV™], there is probably little data to invoke. I would be interested in any evidence.

is for birth control, too

As previously noted, language aware readers and subject matter aficionados know that the “peri” in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology …” nor, for that matter, to “any lovely, graceful person” such as you are.

You already know that “peri” is a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek [http://dictionary.reference.com/browse/peri]. Just like here, whereby we take notice of the Spring Equinox – when the Sun rises exactly in the east, travels through the sky for exactly 12 hours and sets exactly in the west – this year on March 20 “, today.

And, “anyone standing on the equator at noon will not cast a shadow” [http://www.wilsonsalmanac.com/book/mar20.html]. Lovely thought [entertained in snowbound Colorado Rockies]! Then another idea, not necessarily lovely – but a key concept: The dictionary does not tell that this is one of the instances of “kairos time” of the Earth! For the meaning of “kairos time” you can check out an earlier post here, http://biozhena.wordpress.com/2007/12/28/birthday-and-how-it-relates-to-the-biozhena-enterprise-%E2%80%93-eukairosic%E2%84%A2-diagnostic-tools

Spring Equinox (aka rovnodennost)

But now for some more of the tweets (again a little edited, since here we do not have the 140 character limit. And still – in the usual manner – with clickable links to further information, including more tweets of all sorts via the #hash tags).

Do you chart your #fertility cycles? If so, would you like to include our FIV cyclic profile http://to.ly/VCF in your charts? Do let me know if interested #pregnancy #birth 7:24 PM Mar 16th

If you have not yet explored bioZhena’s Weblog http://to.ly/vUz do visit http://to.ly/1kXE Variability of menstrual cycles and ovulation timing. Read on kairos time. 8:05 PM Mar 16th

A collage that depicts our message. After disappointments, once you determine your exact “kairos time” in the cycle you want to conceive in, you’ll get the #pregnancy you wish for http://tweetphoto.com/14671191 8:38 PM Mar 16th

Collage of 3 pics with 15-WordlegreetingsfrombioZhenasf-3.jpg

Mistiming intercourse is the chief cause of apparent #infertility http://to.ly/1ppi . With a certain Fertility Monitor, they claim that 50% of users got #pregnant in the 1st cycle, and 92% in the 3rd. 196 women provided this statistic, out of 276 women asked. “The issue of early intervention with [clinical] tests and medications were highlighted, resulting in escalating costs and strain on the couple.”  2:02 AM Mar 17th

RT@bioZhena Compare the cost of the certain Fertility Monitor, which – unlike ours – requires monthly reagent sticks, from ~$250 (1cycle) to some $550 (10 cycles). Compare that to the average cost of ART medical treatment, which they report was $6,637 for the surveyed women, with a median medical evaluation cost $1,075 per cycle 2:06 AM Mar 17th

... with a median medical evaluation cost $1,075 per cycle ...

Numerous papers http://to.ly/1pq1 show improved #pregnancy rates and effective #birth control with #fertility monitors. That is with focus on determining the #fertile window 2:20 AM Mar 17th

Statisticians reported on day-specific probabilities of #pregnancy with data from 2 studies that used what they called (correctly) Imperfect Measures of ovulation http://to.ly/1pqh They did not ask: Perfect Measure of ovulation soon? 2:34 AM Mar 17th

*Perfect Measure*of ovulation resides in deterministic versus statistical approach.  *Imperfect* (fuzzy) replaced by accurate #fertility determination that indicates the first fertile day and the last fertile day, day 1, day 2, day 3, boom, boom, boom 2:49 AM Mar 17th

Fertile window as determined by the Ovulona, and how it compares with the BBT

You should understand: No in vitro diagnostics (out of body), no circulating hormones like LH and/or estrogen can ever make a RELIABLE #fertility monitoring method – because fertility is the result of a complex integration or interplay of numerous neuroendocrinological signals. This or that hormone in a body fluid does not do that. (It’s merely one of many input signals. In case of the BBT, more like an output.)

Similar caution applies to NFP observations of #fertility signs. Mucus is a measure of estrogen. It does NOT show the boundaries of the #fertile window, it only indicates ovulation is likely, but not when, and not really if

Your #cervix receives #fertility signals from the active ovary and from your brain. But understand that the cervix appearance and feel only indicates approaching #ovulation, not ovulation as such

The appearance of the cervix, like (the appearance of) ovarian ultrasound will indicate that ovulation was yesterday. Or, more accurately put, ultrasound indicates that the follicle collapsed and PERHAPS (80% probability) released the egg

Monitoring your #fertility signs is better than nothing BUT if it’s not helping you to get #pregnant, it will #stress you out and make things worse

Until you use a definitive deterministic tool, “better than nothing” is arguable if you take it from the statisticians that having intercourse about every day for 20 days is 60% likely to result in conception

Of course, you would still have ~40% probability of not achieving #pregnancy so what is new. That is the meaning of #subfertility. Need a solid tool that determines the 3-day fertile window, boom, boom, boom (but stress may prolong this – in a detectable manner).

Our deterministic tool avoids statistics and probabilities, and detects ovulation after anticipating it from what the cervix is saying electronically now, in this cycle. Most of the time not fertile, and then for a few precious days, #fertile

Songs of Innocence and of Experience

To sum up: Appearances are no real measures, they are only approximate.  Approximate is not good enough for #fertility status – to get #pregnant or, especially, to avoid getting pregnant. And, especially, if you want to try for a desired baby gender.

And language aficionados will know that the peri in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology, represented as descended from fallen angels and excluded from paradise until their penance is accomplished.” Nor, for that matter, to “any lovely, graceful person.”

Peri or Paeri of Persian folklore and mythology

Peri is a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek [http://dictionary.reference.com/browse/peri]. Just like here, whereby we invoke the Spring Equinox – when the Sun rises exactly in the east, travels through the sky for exactly 12 hours and sets exactly in the west – this year on March 20. “And anyone standing on the equator at noon will not cast a shadow” [http://www.wilsonsalmanac.com/book/mar20.html]. Lovely!

So then, now for the tweets (a little edited, since here we do not have the 140 character limit, and – in the usual manner – with clickable links to further information, including the #hash tags).

1)         2009 sales of #fertility LH kits at $272M outpaced #pregnancy tests http://to.ly/1p8Q Not exactly surprising since ~30% of US women do not get #pregnant in 6 or 12 months 12:04 PM Mar 16th

2)         #Infertility is “a modern epidemic”. In 17 studies, 56% of the relevant sub-population (range 42–76%) in developed countries sought medical help http://to.ly/1pdo but less than 1/2 of them received care 2:30 PM Mar 16th

3)         Unintended pregnancies = “global epidemic”. US family planning is “uniquely deficient” (50%) http://to.ly/1pcB Cause: high contraceptive failure rates 2:34 PM Mar 16th

4)         Leading causes of unintended pregnancy are closely related to #contraceptive failure. Failure rates: 31% the Pill, 18% condoms, 5% 3-month injectable #birth control 2:43 PM Mar 16th

5)      Medscape OBGYN: #fertility awareness can be highly satisfactory #birth control & #family planning method http://to.ly/1peK http://to.ly/1peM 3:14 PM Mar 16th

6)      RT @bioZhena #fertility awareness [FA] is a great #birth control & #family planning method especially for women 30+ years of age, and those who are able to practice FA without a teacher 3:23 PM Mar 16th

7)      Statisticians: Best frequency of sex for unfocused conception attempts is every 2 or 3 days http://bit.ly/d9tCfm to avoid exhaustion. Else, everyday 5:32 PM Mar 16th

8)      RT@bioZhena But even sex every day for 20 days from day 6 to day 25 only computes as 69% probability of conception. So what else is new in the world of sub- #fertility, wanting #pregnancy but being put into the sub- #fertile category 5:34 PM Mar 16th

9)      Trying to get #pregnant without knowing when-to frequently does not work for a long time. Yet, often all that’s needed is knowing your actual fertile window in the present cycle http://to.ly/VCF 7:18 PM Mar 16th

10)  For #fertility awareness, NFP for #pregnancy and/or #birth control, we have the tool for you http://to.ly/VCF — or, rather, will have once funded. Comments? 7:19 PM Mar 16th

Sex education at school, its quality or otherwise, is likely to have much to do with fertility problems later in life. Many women (men, too, of course) can use the  keyboard with all their fingers (as well as their thumbs!) but have poor understanding of the basic functioning of their reproductive system.

colonial-classroom.jpg

That ignorance is well known, and is underlying the fertility problems. You should see the pregnancy doctors’ tweets – replying to some incredible questions, and then the talk of various mysteries!

A shining example is this tale of “mysterious conception”. For the whole story see the Alphabet of bioZhena under M, “Mysterious conceptions (OR THE NONEXISTENCE THEREOF)” on page 34 or thereabout, from which I cite:

QUOTE:  It appears that we must dwell on this topic, because of stories and notions propagated in various pertinent circles. This writing has been prompted by page 176 in the excellent 1999 book “Woman” by Nathalie Angier, where the Pulitzer laureate relates the story of the mysterious conception of her only child. Mysterious, because it occurred, she believes and makes her readers believe, outside of ovulation and of the fertile window.

The reason for this entry in the Alphabet of bioZhena is that there is NO SUCH THING AS MYSTERIOUS CONCEPTIONS, there is only lack of information, or ignorance of the facts. We might say, intellectual misconceptions lead to “mysteries” in terms of conception, of babies conceived supposedly when conception was biologically impossible, and vice versa, some women have difficulties conceiving for the same fundamental reason. We shall use Ms. Angier’s case to make this point. UNQUOTE.

To drive the point home, here is an excerpt from John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine, Volume 31 (No.8), Supplement, 742 – 747, 1986.

Referencing particularly large studies from 1967 and 1977, these BBT experts had this to say all those years ago (and never mind their “prediction” in the cited title whereas the BBT is well known to be no predictor):

QUOTE:  Cycle regularity is often assumed by both women and their physicians. The suggestion, that the BBT graph of the previous cycle can be used to identify the day of ovulation in the current cycle, requires nearly absolute cycle regularity. [However, note this:] The data collected by 1,085 women, who provided at least 6 or more charts each, were studied for cycle length variability. … The cycle length range was more than five days for 56% of the women who submitted 6 graphs, and for 75% of those with 12 graphs. … Absolute regularity was not demonstrated in as few as six cycles. Even when the cycle length that deviated the most was eliminated, less than 1% (8 of 1,085 women) had no variation in cycle length. When the number of cycles was extended to 12, no woman had variability of less than two days in cycle length. END OF QUOTE.

In real life, you realize, no cycle can be eliminated from the experience, and every day matters. Two days are very likely to make the difference between conception and the lack of it. And/or cause an unwanted pregnancy, for that matter.

on_the_ball.jpg

The above findings are therefore the basis on which we can say quite categorically that nobody is as regular as a metronome (and nobody conceives in an anovulatory cycle), that there is no such thing as absolute regularity, whether 28 days or otherwise.

If you are in the sub-fertile category of people finding it difficult to become pregnant, you are likely to have cycle variability of more than 5 days over those months of your fruitless efforts that define your category. More likely than being one of the 0.74% of the population with no variation in cycle length, which under ideal conditions may also mean no variation in the time of ovulation. Persistent monitoring is well advised.

And yes, stress has something to do with it

In the previous post, I wrote that we would suggest that the terminology that speaks of sub-fertility or reduced fertility is misleading. If you did not stumble over it wondering why, then I am glad for you (I should say, for both of you!). Because you “got it” and will now think of taking some appropriate steps, and those will NOT be to your insurance agent and/or – more likely – to your bank!

Because you understand that, until proven otherwise, your situation should be termed one of “instant conceptive gratification cannot be had probably due to wrong timing”. Nothing reduced or sub- about that! And, the adjective “conceptive” is meant to indicate that the hope is that the other kind of gratification has obtained. The one I referred to as physio-pleasure, but that would be a topic for another time…

Let me remind you of the gist of the previous article with this picture. -

Collage of 3 pics with 15-WordlegreetingsfrombioZhenasf-3

The collage is meant to be suggestive of the message from bioZhena. After some disappointments – if no steps were to be taken to determine the right time (aka kairos time, in the terminology of ancient Greeks) – with the help of our Ovulona you will get the pregnancy that you wish for.

This happy end is represented in the third part of the composite graphic, which part is what they call a wordle. It is a wordle of this here bioZhena’s Weblog, showing the first 15 most frequently used words in the blog as of a few months ago (the font size is a measure of the respective words’ usage frequency). I called the piece “15-Word(le) Greetings from bioZhena’s Follicular Waves”, as the waves are hinted at there, are they not. Learn about the follicular waves, or rather about Folliculogenesis In Vivo™ [FIV™], and you will get what you wish for.

Since you are not likely to have reviewed the menstrual variability references given in the previous post, I will document the notion of wrong time with our data. I mean the data from a small clinical trial carried out with a prototype of our core technology, the Ovulona™ for home use. This trial was performed by an independent group at Marquette University NFP clinic – with patients attending the clinic to learn NFP for one of two reasons: either because they experienced difficulties in achieving pregnancy, or because they wanted to learn NFP [Natural Family Planning] as a means of birth control. Or, maybe, they wanted to use NFP for both, at different phases of their lives.

We can look at data of 10 women, 2 cycles each, reviewing here the ovulation data obtained with said prototype of our Ovulona device.

The data are systematically documented (along with two reference methods for comparison) in the attached 1-page document (Variability of menstrual cycles), and I am doing my utmost to boil it all down for you to as brief a briefing as possible.

Listing of two consecutively detected ovulation days (ovulation marker detected by our device), and noting whether the cycle was subsequently categorized as regular or irregular, goes like this:

Ovulation day number in 2 consecutive cycles

The list goes on, and you should know that “irregular” means “challenged”, and means something of a problem that our modern lifestyle presents to the biology of our women.

One patient provided data from her four cycles, and the variability was – not surprisingly – even more pronounced (-5 days, +5 days, -3 days):

The following table shows the wide spread of the differences between ovulation days in two consecutive menstrual cycles of 10 women attending said NFP clinic.

Summary of 10 patients, 2 consecutive cycles each

Differences from -5 to +3 days are recorded in this small sample, and the one woman with 4 cycle records showed +5 days, too, which illustrates that the more cycles are followed, the larger the spread of ovulation days becomes (this is “cycle irregularity” in the conventional, usual sense).

Our meaning of regularity is indicated and documented in the attached summary, “Variability of menstrual cycles”. Regular cycles are those where our ovulation marker is within 1 day of LH peak or of the day of Peak mucus (Pk).

Our meaning of irregularity is defined as those cycles where the ovulation marker day data is not within 1 day of said hormone-detecting parameters (LH and estrogen, respectively), and is always higher – signifying delayed ovulation (delayed with respect to the hormonal signals).

As I said above, “irregular” in our parlance means “challenged”, and it means something of a problem that our modern lifestyle presents to the biology of our women. More often than not, the challenge is stress, which I discussed in this blog earlier in at least two posts. Our FIV technology (aka the Ovulona personal monitor) detects the effects of stress, and helps to deal with the consequences in terms of its effect on fertility status.

This article is about the basic cause of most disappointed efforts at achieving pregnancy. The basic cause of the disappointment is that intercourse is had at a wrong time. That is, not during the kairos time of your menstrual cycle, the right time, during which – and only during which – fertilization can occur and result in conception (that may lead to successful pregnancy).

Note that we are not talking here about the relatively few cases of real clinical infertility that are caused by certain organic problems such as, say, blocked fallopian tubes or similar.

We are referring here to what is termed by experts (medically classified) as reduced fertility or sub-fertility. This refers to the predicament of people who cannot achieve pregnancy for too long. We would say that even this terminology is misleading but it is well established in OBGYN medicine, so let’s work with it.

Of course, “cannot achieve pregnancy for too long” is medically expressed more quantitatively by postulating the number of months during which the attempts to conceive a baby turn out to be fruitless, disappointing. (Do we need to add that, as a consequence, what is supposed to be a significant physio-pleasure then often becomes a chore, with the stress only exacerbating the painful disappointment and the actual problem?) Yes, stress enhances the problem.

For many years, the number of months during which unprotected intercourse does not result in pregnancy (and is classified as sub-fertility/reduced fertility) was defined as up to 12 months. For 12 months of fruitless attempts to get pregnant you were sub-fertile, suffering reduced fertility. Only after a year, you became a case of clinical infertility.

More recently, as the prevalence of these problems increases, some medical authorities have extended this period of “advised patience” to as long as 2 years. Only after this extended period of advised patience in trying to conceive would the woman and/or couple be put into the clinically infertile category.

The basic cause of most failed efforts to become pregnant is simply wrong timing, wrong time within the menstrual cycle when the unprotected intercourse occurs with the intent to conceive a baby. This wrong time has much to do to with the continued belief, carried over from earlier times, that most menstrual cycles are “regular”. This is one of the myths. The exact opposite is true.

In fact, there is no such thing as cycle regularity. It is therefore essential to perform persistent monitoring, as the phrase goes nowadays, to determine the right time for a conceptive intercourse.

It was found decades ago that most women experience changes of even more than five days in the length of the menstrual cycle, and therefore also changes in the day of ovulation. This fact of life is basic to the predicament of finding it difficult to achieve pregnancy.

Fact:

Less than 1% of women would be found with no variation at all, even for short sequences of only a few menstrual cycles, and absolutely no-one would be regular in more than about five cycles. [Ref.: John J. McCarthy, Jr. and H.E. Rockette, "Prediction of ovulation with basal body temperature", Journal of Reproductive Medicine 31 (No.8), Supplement, 742 - 747, 1986; also – and particularly - see refs. therein to the largest studies, i.e., to R.F. Vollman, "The menstrual cycle", 1977, and A.E. Troelar et al., "Variation of the human menstrual cycle through reproductive life", 1967.]

The research involved thousands of BBT [Basal Body Temperature] records obtained from correspondingly high number of women. The research was carried out when the hope was that the then new technology of the micro-computerized thermometer would provide the answer to the quest for a definitive tool for reproductive management. Well, it did not.

The BBT is not the answer, it cannot be. It’s not the solution because it is notoriously unreliable, whether micro-computerized or measured with an ordinary thermometer. Simply put, the BBT is affected by too many things, and it has been found to rise anywhere from 3 days before to 3 days after ovulation, despite the expected rise immediately after ovulation.

Comment:

The sympto-thermal method of NFP practice, also known as the Billings method, gets around the notorious lack of reliability of the BBT by having women perform certain anatomical observations “down there” and observations of the appearance of the fluid wiped off “down there”. Subjective as this enhancement is, in a review of a sufficient number of cycle records you would see that it is more likely the sympto- observations than the thermal measurements that, when lucky enough, are associated with recorded pregnancy-test positive. Basically, any of this helps the woman to stay focused, and the lack of accuracy is made up for by an as high frequency of intercourse as practical or desirable. Like shooting in the dark with an automatic weapon… (but then, if there is no target in the dark…)

I got off on this tangent, and should come back to the inherent variability of menstrual cycles and ovulation times in another post. To impress on you that this basic fact of life is particularly important when you are finding it difficult to get pregnant – probably because you are past the most fertile years, which are – or, rather, were – the early twenties of your life.

“Ask Medical Doctor” [http://www.askmedicaldoctor.com ] is a web site that provides numerous examples where it follows that our Ovulona™ personal fertility device will be just what the customer needs – whether the doctor orders it or not. In a manner of speaking, as a play on the phrase “just what the doctor ordered”. Naturally, we’ll want the doctor to order it, as a matter of course, but our marketing will ensure that the customers will be asking for it – or about it. No prescription should be required.

As an example, here is a posted question (courtesy of @pregnancydoc tweet) [http://www.askmedicaldoctor.com/medical/doctor/index.php?xq=63935 ]:

“I quit the nuva ring at the end of november, and had a short cycle. I was only on it for a month. My husband an I are trying to conceive. Last week I had a blood pregnancy test, which was negative. As well as the week before. Now I’m almost a week late. I’ve also experienced a little bit of breast tenderness, stomach tenderness, and lower back pain. what’s up?”

Answer by Dr.Bhumika Aggarwal (doctor) on Fri 08, Jan 2010 10:33pm:

“Hi, Yes you could be pregnant. The only way to know the confirmed cause is a clinical examination by an OBG specialist and if required an ultrasound examination. You could take a urine pregnancy test at home – that would only help a week after you have missed your periods. You should get a blood test for beta HCG levels which would confirm or rule out a pregnancy. This is confirmatory for pregnancy in cases where the urine pregnancy test kit is not helpful. It would be best to consult your doctor without any delay. Regards.”

Commenting about the Ovulona device, and the Ovulona advantage:

The above case is not unusual, including the fact that, after quitting contraception, the cycle(s) will tend to be short, out of whack. More to the point, however, is that, with the regularly used Ovulona, pregnancy will be detected immediately, by the disappearance of the follicular waves normally appearing in the luteal phase of the cycle [the days after ovulation], whether the cycle is short, long or what have you.

See a pictorial explanation of the cyclic profile in bioZhena Weblog:

http://biozhena.files.wordpress.com/2009/10/baseline-cycles-interpreted.jpg?w=600

For a narrative about the folliculogenesis cyclic profile, go to the blog post:

http://biozhena.wordpress.com/2009/10/10/what-women-know-and-what-they-want-to-know

Where the physician talks about the urine and blood pregnancy testing is where it gets interesting. When Dr. B. A. writes, “that would only help a week after you have missed your periods”, with the Ovulona the detection will be immediate and, importantly, the Ovulona will make it possible to monitor the progress of the pregnancy. Where the doctor writes, “You should get a blood test”, that will no longer be the only option for the woman in the early days of uncertainty about her pregnancy status, or in the subsequent early stage of pregnancy.

The point is this: The hCG level in the blood shows the presence of the conceptus, and the immediate disappearance of the follicular waves is expected to show the presence of the conceptus before the hCG test can. The reason is that the hCG test requires a certain minimal level of the human Chorionic Gonadotropin to be reached, and then the blood concentration peaks on the analytical instrument’s readout that the service lab will use.

This is how the pregnancy shows in the lab test for hCG:

Conceptus signature - small

Figure from Proc. Natl. Acad. Sci. U.S.A. 96 (6): 2678–81 (March 1999)

http://www.pnas.org/content/96/6/2678.figures-only or http://to.ly/OYI

See also http://en.wikipedia.org/wiki/Human_chorionic_gonadotropin, or http://www.webmd.com/baby/human-chorionic-gonadotropin-hcg .

“Once the fertilized egg implants, the developing placenta begins releasing hCG into your blood.” “HCG appears in the blood and urine of pregnant women as early as 10 days after conception” [http://www.nlm.nih.gov/medlineplus/ency/article/003510.htm ].

“In non-pregnant women, hCG levels are normally undetectable. During early pregnancy, the placenta produces hCG and its level in the blood doubles every two to four days” [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109390.htm ].

Nothing is perfect, and “hCG kits can detect a wide and varying range of different hCG-related molecules in serum or urine samples” rather than just the one molecule they want to detect [http://www.hcglab.com/index.html ].

“The primary role of hCG in the maternal organism is to serve as a signal to the ovary to maintain the corpus luteum, which would regress if it were not rescued by hCG. … It appears that exponentially increasing amounts of hCG are required to prolong the functional lifespan of the corpus luteum, which explains why the corpus luteum survives early pregnancy but regresses during unfertilized menstrual cycles…” [Parry, S, Glob. libr. women's med., (ISSN: 1756-2228) 2008 http://to.ly/P0z ]. Corpus luteum (yellow body) is defined as a yellow, progesterone-secreting, mass of cells that forms from an ovarian follicle after the release of a mature egg (i.e., ovulation), http://to.ly/P0B . It is what becomes of the follicle after ovulation.

Against that background, we bring up the following expected effect of conception on the folliculogenesis profile as it is tracked by the Ovulona and used by the woman at home. The data accumulated in the memory of the device will be available for optional use by her physician and the healthcare system.

Précis: When conception occurs, the normal folliculogenesis process changes due to the developing pregnancy (i.e., due to the conceptus). Conception can only occur upon ovulation, and when it does then the change happens. The follicular waves that normally occur after ovulation can no longer appear.

Upon conception, the maternal menstrual cycling is overruled, taken over, by the conceptus and the placenta. Conceptus is defined as the product of conception at any point between fertilization and birth. It includes the embryo or the fetus as well as the extra-embryonic membranes [http://to.ly/P0t , conceptus is from Latin, something conceived; see concept].

The disappearance of the follicular waves will be immediate, and easily detectable. Importantly, as with the monitoring of folliculogenesis for the purpose of either achieving or avoiding pregnancy, it will be presented to the woman at home in plain English as “pregnancy detected” on the display of her Ovulona device.

A very important (and unprecedented) additional advantage of our technique is that any loss of the pregnancy will also be detected in the process of continued routine monitoring for an as yet undetermined period into the early pregnancy (perhaps first trimester, <13 weeks). This is advisable because many conceptions end in natural loss, i.e., the early death of the conceptus. E. g., “absence of TLX antigen recognition due to sharing of maternal-paternal TLX antigen profiles may not allow anti-TA1 activity and may lead to subsequent fetal rejection”, http://to.ly/P1S .

Between one quarter and one third of pregnancies may fail hours or days after implantation [  http://www.hcglab.com/hyperglycosylated.htm , citing Prenat. Diagn. 1998;18:1232–40 and J. Endocrinol. 2002; 172: 497-506]. But see also Further References, below, where the incidence is put at 75%+ of all attempts to conceive – the most common complication of human gestation.

In view of the fact that “treatment of women who present with cramping and spotting in the first trimester of pregnancy would be better guided by a sensitive and specific test that would reliably categorize prognoses for pregnancies”, it is worthwhile to speculate as follows. Since “progesterone appeared to be the single most specific biomarker for distinguishing viable from nonviable pregnancies” [Obst. Gynecol. 2000, Vol. 95, Issue 2, pp. 227-231, http://to.ly/P39 ], and in view of our sensor’s mode of operation (and the expected response to conception), we might even speculate that differentiating between viable and non-viable pregnancies might be attempted with our technique, too.

As throughout the whole text in this article, speculate is the key word.

Further References:

Efficiency and Bias in Studies of Early Pregnancy Loss, Clarice R. Weinberg, Irva Hertz-Picciotto, Donna D. Baird and Allen J. Wilcox, Epidemiology, Vol. 3, No. 1 (Jan., 1992), pp. 17-22, http://to.ly/P3s

Early Pregnancy Loss,  http://emedicine.medscape.com/article/260495-overview Note: Chief Editor is Lee P. Shulman, MD – one of bioZhena Corporation’s Board of Medical Advisors.

Excerpted:

Early pregnancy loss is unfortunately the most common complication of human gestation, occurring in at least 75% of all women trying to conceive. Most of these losses are unrecognized and occur before or with the next expected menses. Of those that are recognized, 15-20% are spontaneous abortions (SABs) or ectopic pregnancies diagnosed after the pregnancy is clinically recognized.

The incidence of spontaneous miscarriage is10-15%, whereas the rate of recurrent miscarriage is 3-5%.

Approximately 5% of couples trying to conceive have 2 consecutive miscarriages, and approximately 1% of couples have 3 or more consecutive losses. Early pregnancy loss is defined as the termination of pregnancy before 20 weeks’ gestation or with a fetal weight of <500 g.

The gestational age at the time of the SAB can provide clues about the cause. For instance, nearly 70% of SABs in the first 12 weeks are due to chromosomal anomalies. However, losses due to antiphospholipid syndrome (APS) and cervical incompetence tend to occur after the first trimester. END QUOTE.

Medline ® Abstracts for References 3-5,7-9 of ‘Spontaneous abortion: Risk factors, etiology, clinical manifestations, and diagnostic evaluation’ http://to.ly/P4e

Citing from one abstract on the list: “Preterm death of the human conceptus is common.”

Conclusion of a 2003 paper from China: We demonstrated substantial EPL in the non-clinically pregnant cycles and a positive relation between EPL and subsequent fertility. EPL = Early Pregnancy Loss. The conception rate per cycle was 40% over the first 12 months.

There is no device in the marketplace today that would tell you, in plain English, “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy. And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy.

There is no such device on the market that would subsequently confirm the pregnancy within days – when, after ovulation on fertile day 3, you – or, rather, your Ovulona device for you – will no longer register the usual follicular waves. Your Ovulona device will interpret that as pregnancy detected, because that is how the biology works.

There is no device out there that would identify the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. The commercially available fertility monitors cannot detect either delayed ovulation (which happens due to stress) or when ovulation does not occur at all. In fact, they do not detect ovulation, they just guess at it.

Because the currently marketed fertility monitors (ovulation predictors) cannot detect ovulation, they merely assume its occurrence due to the particular hormonal marker-predictor of their choice (usually LH, in some cases estrogen, in one case both). But no single hormone, even if it were detected with the accuracy of laboratory methods, determines the fertile window. It’s much more involved than that.

Here: What Women Want To Know

Only scarcity of funds keeps us from marketing a device doing all those things not available today.

Our personal self-diagnostic device, the Ovulona™, will tell the woman user in plain English (or any other language) whether today is one of the three days when she can become pregnant.

http://biozhena.files.wordpress.com/2009/10/fertile-window1.jpg?w=600

Fertile window

How? We’ll have the woman monitor at home the process that causes menstrual cycles and is fundamental to women’s health. The use of the Ovulona device is very simple, just like a tampon, except that it is inserted for only a few seconds (about 20) to obtain the result, with an instant display of the result.

Primary use is for reproductive management – that is aiding the achievement of pregnancy, and also aiding fertility-awareness based non-invasive birth control. But there is much more, including an automatic screening for cervical cancer, management of PMS/PMDD and management of hormone therapy, to name just a few useful applications that will come with the core technology.

We show the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle. The graphs produce cyclic profiles descriptive of the nuances of the monitored menstrual cycles. None of the old techniques can do that.

These cyclic profiles have important characteristics:

1. The cyclic profile has numerous repeatable features.

2. The range of readings is the same in different cycles and, importantly, also in different women.

3. The profile features are interpretable, and are due to the biological process that causes the menstrual phenomena (folliculogenesis).

The significance of these profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology. (As such, not readily funded by the established financing channels, and we are seeking well matched financial partners that will not run the project to the ground.)

http://biozhena.files.wordpress.com/2009/10/fertile-window-for-birth-control.jpg?w=600

Fertile window for birth control

For a better insight, visit the other posts on this blog [ http://biozhena.wordpress.com/ ], and check out http://www.linkedin.com/in/vaclavkirsner.

Before you go, see this, to get a sense of what is going on here:

http://biozhena.files.wordpress.com/2009/10/baseline-cycles-interpreted.jpg?w=600

Baseline cycles interpreted

Not included in this illustration is the use of the follicular waves for early pregnancy detection (the waves disappear; the right term for this is “instant pregnancy detection”), and monitoring for early pregnancy loss (in that unfortunate eventuality, the waves come back; it is advisable – by certain recent findings – that the couple should not delay trying to conceive again). Refer to the following for more about said recent findings: original medical publication in BMJ http://to.ly/9WtG; BMJ editorial comment http://to.ly/9WtI; CNN.com article “Miscarriage? Try again ASAP, study suggests” http://ht.ly/2mlwb; bioZhena’s post on the subject http://to.ly/802p (“Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25″).

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Parties with an interest relevant to bioZhena Corporation will be provided with more confidential information upon request (email: vaclavkirsner@yahoo.com).

The purpose of this article is to bring to your attention the big picture. That is the fact that the potential impact of the bioZhena technology goes beyond reproductive management. We illustrate how we mean it when we invoke the vision that the Ovulona device will become a friendly routinely-used companion tool with numerous diagnostic ramifications for women everywhere.

The natural interest of the woman-user in being in charge of her reproductive life leads to the possibility of using the information gathered in the process for additional medical purposes, some not so obviously connected with the menstrual cycle signature. (The Ovulona cyclic profile is the signature.)

You will follow the discussion here better if you peruse the bioZhena weblog article, listed under Pages and titled, What is symptometric? What is the meaning of “symptometric data”? The answer in a nutshell: Symptometry means symptoms quantified and charted.

Now for a possible application. You probably do realize that there are gender differences in how patients respond to therapy, and you do not need reminding that cardiovascular disease is a big problem for women’s health, far from killing mainly male victims.

In this context we hint at an electronic interface that will function to navigate through a menu that provides for a daily registration of quantified symptoms by means of one of the standard medical symptometric inventories such as the Calendar of Premenstrual Experiences (COPE), or the Daily Record of Severity of Problems (DRSP), etc. This will replace the paper forms used today.

The DIU will facilitate electronic recording of quantified symptoms

By design, the symptometric data will be correlated with the Ovulona data on folliculogenesis – and will be far better than the old, inefficient and costly, paper-using procedures of yesteryear (those did not employ any folliculogenesis correlation, of course). No need to invoke the evolving societal developments in general healthcare policy towards cost-effectiveness, etc.

A recent health news headline declares: “More evidence that depression is hard on the heart”, and here is the synopsis: Severe depression may silently break a seemingly healthy woman’s heart. Doctors have long known that depression is common after a heart attack or stroke, and worsens those people’s outcomes. Monday, Columbia University researchers reported new evidence that depression can lead to heart disease in the first place [http://channels.isp.netscape.com/news/story.jsp?floc=ne-story-9-l9&idq=/ff/story/0001%2F20090310%2F0629929017.htm&sc=1500 03/10/09 06:29 © Copyright The Associated Press].

The issue is not the reported “big surprise: Sudden cardiac death seemed more closely linked with antidepressant use than with the depression symptoms the women reported. That might simply mean that women who used antidepressants were, appropriately, the most seriously depressed, cautioned lead researcher Dr. William Whang. But he said the finding merited more research” [loc. cit.].

The issue is that not only more research but all routine women’s health practice requires the knowledge of how symptoms relate to (correlate with) the course of the menstrual cycle or, more accurately put, the course of folliculogenesis.

For an illustration, refer to Premenstrual syndrome (PMS) and PMDD

Effective therapy requires this (differential diagnosis), and our technology will do three things for public health:

1. Enable routine quantitative recording of symptoms,
2. Correlate symptoms with the underlying folliculogenesis process, and
3. Allow for individualization of therapy (titrate medication doses for individuals).

This is one of the examples of non-reproductive applications of the bioZhena planned products; this is simply a reminder that the core product, the Ovulona™ for reproductive management, is far from the only planned product offering.

The Ovulona™ is the core product with various diagnostic ramifications within the bioZhena Fertility and Health Awareness System™.