Difficult to conceive – Google evidence that pregnancy complications and trying-to-conceive concerns shot up after the Pill launch in 1960s

Regardless of what contraceptive proponents tell you

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 all 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. Oh, and should this not be clear, the metaphor here pertains to the man-made OCP [Oral Contraceptive Pill] accomplishment…

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…

STOP PRESS

And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Seven billion people – after half a century with the Pill

More than a week before the numerologically so exciting (!!) date of November 11 this year of AD 2011, the population of the world officially reached the count of 7 billion – and this should not go unnoticed in a blog that is about women’s health and human reproduction management. Why, by the time the 11-11-11 day came about, more than 2.5 million more babies were born around the world.

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 most of the last half a century, world population grew in steps of one billion per 12 years.

We see that reaching the first billion of humans took more than 18 centuries (including BC). 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 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 quite 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 statistics 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 much 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 although it appears to have reduced the extent of the explosion.

But at what cost? Do 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.

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

The Ovulona is not another ovulation kit, my dear

@bioZhena‘s reply to Jennifer K. who wrote: How is this different from the other ovulation kits on the market today? It seems very similar to products I have seen before. QUOTE UNQUOTE

Actually, Jennifer, you are mistaken. There is no such thing available to you in the marketplace today.

bioZhena intro in 10 mostly narrated slides https://v.gd/nq5d2j

Cervical health screening, pregnancy monitoring and other applications will be introduced while generating revenues with the already FDA-cleared minimum-value application of the core Ovulona^TM product.

This blockquote is added in April 2017

ovulona-single-slide-3-day-fertile-window-forexs.pps

None of the ovulation kits – which the Ovulona™ is not – or any other fertility-status monitors on the market today have the required ability to determine fertile day 1, fertile day 2, and fertile day 3 (= ovulation, the last day of the fertile window).

All the existing techniques merely guesstimate the approach of ovulation, and none of them can detect ovulation separately from predicting it. They detect neither the first day nor the last day of your brief fertile window – so, they declare the fertile window to be wider than it actually is.

Let’s try to illustrate this with the following graphical comparison of the Ovulona 3-day fertile window versus the fuzzy and much wider, uncertain window indicated by one of the old techniques. (In this case depicted here it was the so-called Peak mucus method but LH kit and BBT yielded similarly wide and fuzzy fertile periods, that is the days on which intercourse resulted in pregnancy.)

Ovulona 3-day fertile window versus one of the old methods

Because in the Old Method ovulation was only guessed at, a fuzzy fertile period obtained.

Fuzzy and long. Wrong.

There is no device in the marketplace that would tell you, in plain English (or in Spanish, Chinese or maybe even in Czech!), “today is your fertile day 1” – meaning that unprotected 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. We base this expectation on the results of other people’s studies, referenced below.

The rationale, briefly, is this: The male sperm live long enough to be available for fertilization when ovulation releases the ovum (egg) from the ovulating ovarian follicle. Whereas the female X-chromosome bearing spermatozoa have a chance to produce a baby girl only if intercourse takes place on the day of ovulation, because of their short lifespan. With the Ovulona, the rationale will have a chance to be tested and/or utilized in real life…

No such powerful tool out there

There is no device that would – subsequent to determining the days of the fertile window – confirm the pregnancy within a day or two. When, after ovulation on fertile day 3 (indicated in the graph here as day 0), your Ovulona would no longer register the usual follicular waves – and the device would interpret that as pregnancy detected, because that is how it works.

In gynecological convention, days of the menstrual cycle are counted from the first day of menstrual bleeding, but the researchers involved in studying the prediction of ovulation use also another counting system. In that counting system, the day of ovulation is day 0 (zero). This is to allow for comparisons of different cycles, because cycle lengths as well as the phases of the menstrual cycle vary from month to month and also, of course, from woman to woman.

Because the sperm can remain viable for several days but the egg can be fertilized only for several hours after ovulation, there are several fertile days before ovulation. Should the egg remain viable for fertilization longer than the believed 12 to 24 hours, there would be also one fertile day after the day of ovulation. Delayed ovulation will have this effect and this is discussed below. Only our menstrual cycle tracking technology can detect delayed ovulation, a very important attribute.

We believe that published evidence from clinical studies of this problem leads to the conclusion that there are only 3 days of high probability of getting pregnant, and that the ovulation day is the last day of this narrow fertile window.

For more on the foundation of this hypothesis (i.e. for the working hypothesis of the 3-day fertile window), see https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ where we show the outcome of the France et al. study of fetal gender pre-selection superimposed on the menstrual cyclic profile generated by our device in a small clinical trial. This indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace.

This is how come that, in the illustrations above including this one, the days of the fertile window are counted back from ovulation, and hence their negative signs in the graph. Day -2 on this time scale is the first day of the fertile window. It is clearly discerned in our menstrual cyclic profile signature, as shown in the first illustration of this post.

How prior art products and methods fail

If you only detect the ovulation day with your LH kit, it is too late for the previous 2 fertile days. Similarly, if you detect an elevated BBT temperature, which rises and remains elevated after ovulation, it is also too late. The timely determination of the pre-ovulation fertile days has always been THE key problem for NFP [Natural Family Planning] and generally for the Fertility Awareness Based Methods of reproductive management.

There is no device out there that would determine the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial.

The other fertility monitors – including the more recent smart phone apps – cannot detect delayed ovulation (which happens due to stress) despite the LH hormone signaling that ovulation should go ahead. Neither can the various other monitors warn you when ovulation cannot occur because of the failure of dominant follicle maturation in the present menstrual cycle.

There is no other device that would enable you to avoid the expense and hassle of trying to become pregnant with the help of the costly Artificial Reproductive Technologies when your dominant follicle maturation is not happening – which is only detectable with our folliculogenesis-tracking little device for home use.

Your gynecologist, your family doctor – or your psychiatrist if you suffer badly with PMS (diagnosed as PMDD) – does not have the benefit of the folliculogenesis cyclic profiles stored in the Ovulona memory for better diagnosis and better treatment than you can get today. They do not as yet have the benefit of systematic longitudinal recording of your menstrual cycle vital sign signatures, to facilitate better diagnosis of a health problem such as you may have.

There is no other technology that would – automatically and without bothering you at all – keep track of whether your cervical tissues are healthy, and would issue a warning only when detecting tissue aberration several months in a row – to spare you the anxieties and expenses associated with the Pap smear cervical cancer tests’ frequent false positives. Yes, this too is a functionality planned for the Ovulona in the future.

There is no technology as yet available to all women worldwide with these empowering features at a perfectly affordable cost.

oh yeah

Read also the 2012 article https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/ – The fallacy of ovulation calculators, calendars and circulating-hormone detectors.  Don’t let them lead you by the nose with likely this and probable that! You need to know for sure. Day 1, day 2, day 3. Simple.

Should you want to look deeper into this, do check out the  Home Page of bioZhena’s Weblog

Contact me via email at vaclav@biozhena.com

Parturition means birthing (birth) and dystocia a difficult one

And what is a parturition alarm?

For these and other entries, see the Alphabet of bioZhena at

https://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena/

Parturition alarm:

This is a concept that has to do with the need to know when labor or delivery is beginning, because the birthing female may be in need of help.

At the time of writing the first Alphabet draft more than five years ago, an Internet search produced only one such technology, a pressure-sensing girth, suitable for the horse breeder only, because it utilizes the fact that the horse mare lies on her side only in the process of parturition. To illustrate, we borrow a nice picture from a more recent publication found in today’s search on parturition alarm, which search still shows a preponderance of equine innovations:

In the originally noted publication, reference was made to some other method that would detect the emergence of the amniotic sac or of the foal from the vulva (vaginal orifice) but that was not a satisfactory solution. In the horse-breeding arena, about 5-6% of births require help. Various approaches to the birth alarm solution have been attempted.

These days, there are quite a few patents etc. found in the parturition alarm search. And even 5 years ago, a patent from New Mexico University should have been found because their intra-vaginal parturition alarm patent (basically for cows) was published in 1987.

In human obstetrics, where most births take place in hospitals, determining the right time of confinement would be very beneficial. bioZhena (and/or its sister company, bioPecus) will investigate our vaginal sensor technology – suitably modified – with a view to developing a parturition alarm applicable to any mammal.

Also relevant in this context is the implication of the Ovulona making available the menstrual cycle (folliculogenesis) data over many months or cycles before conception. This will enable a more accurate anticipation of the EDD, Expected Date of Delivery. You will understand this better below, under Parturition. I highly recommend that you check out Figuring Your Due Date, too – from the Midwife Archives.

Let us put it this way: Since this is the bioZhena blog (and not bioPecus, for veterinary tools), the EDD issue must be addressed first, before any parturition alarm developments. Because we are primarily concerned with the Rerum Naturare Feminina.

And it would still be of great interest to hear from an expert Latinist about the correct way of saying this in plural, the Natural Thing of Women, the Women’s Natural Thing…

This being a reference to /2007/12/16/cervix-uteri-and-seven-or-eight-related-things/ .

Parturition:

The process of giving birth; childbirth. [From Late Latin parturitio, from Latin parturitus, past participle of parturire, to be in labor.]

Parturition is illustrated at http://www.mhhe.com/biosci/esp/2001_saladin/folder_structure/re/m2/s5/ .

The illustration’s legend indicates that physicians usually calculate the gestation period (length of the pregnancy) as 280 days: 40 weeks or 10 lunar months from the last menstrual period (LMP) to the date of confinement, which is the estimated date of delivery of the infant [EDD].

Indubitably, due dates are a little-understood concept:

“Truth is, even if you know the exact date when you ovulated, you still can only estimate the baby’s unique gestational cycle to about plus or minus two weeks” [ http://www.gentlebirth.org/archives/dueDates.html ]. Why should that be? Because of the variability of your menstrual cycle lengths? (They vary even if you do not think so).

Statistically, the gestation time for human babies has a mean of 278 days and a standard deviation of 12 days, an uncomfortably large spread. The old Naegele Rule of a 40-week pregnancy was invented by a Bible-inspired botanist Harmanni Boerhaave in 1744 and later promoted by Franz Naegele in 1812. It is still believed to work fairly well as a rule of thumb for many pregnancies. However, the rule of thumb also suggests: “If your menstrual cycles are about 28 days, quite regular, and this is not your first child, your physician’s dating is probably fine. If your cycles are longer or irregular, or if this is your first child, the due date your physician has given you may be off, setting you up for all kinds of problems” (induction, interventions, C-section among them).

This is where the bioZhena technology can be expected to provide help, making it possible to reckon the EDD with recorded menstrual cycle (folliculogenesis history) data rather than merely with the LMP + 280 days. This, once properly researched, may be expected to have a significant impact on obstetric management. — Any comments?

It is ironic that, in this age of technological medicine, American women worry about their birthing process not being allowed to take its own natural course on account of an ancient method of predicting the EDD.

Ironically, the 40 week dogma – which is the gestational counterpart of the unacceptable calendar method of birth control (the so-called “Vatican roulette”) – does not reconcile the 295+ days of the 10 lunar months; and yet, at the same time, the U.S. has an unusually high perinatal death rate, resulting from high statistics of too early (preterm) labor. Quid agitur? See also under Gestation.

Dystocia or birthing difficulty:

Dystocia is difficult delivery, difficult parturition. From Latin dys-, bad, from Greek dus-, ill, hard + Greek tokos, delivery. Calf losses at birth result in a major reduction in the net calf crop. Data show that 60% of these losses are due to dystocia (defined as delayed and difficult birth) and at least 50% of these calf deaths could be prevented by timely obstetrical assistance. The USDA web site http://larrl.ars.usda.gov/physiology_history.htm is apparently no longer there but when it was it indicated that an electronic calving monitor was being developed to determine maternal and fetal stress during calving. These studies are important since they are leading the way for developing methods to reduce the $800 million calf and cow loss that occurs each year at calving in the USA’s beef herds.

In analogy with the superiority of in vivo monitoring of folliculogenesis versus tracking behavioral estrus (heat), in vivo monitoring of the progress towards parturition must be a priori a more promising approach.

The telemetric version of the BioMeter – the animal version of the Ovulona technology – will hopefully provide a tool for these efforts. Once tested on animals, human use will be a logical extension of the endeavor. (Or endeavour, should it take place in Europe! Smiley…)

Comment about the EDD and/or EDC issue, and request for input:

Again, EDD stands for Estimated Day of Delivery, while EDC stands for Estimated Day of Confinement.

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age [ http://findarticles.com/p/articles/mi_g2602/is_0002/ai_2602000272 ], ” 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.”

The Ovulona device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse. In every cycle, whether pregnancy is planned or not. This must become a part of the routine. The information will be electronically recorded along with the daily or almost-daily measurement data inherent in the use of the Ovulona. With that menstrual cycling history data, this intercourse-timing information will be available for optional use by the woman’s physician(s).

Therefore, the routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation available to the women receiving IVF or artificial insemination.

This alone should be an improvement on the current way of EDD/EDC assessment.

In addition, an investigation should be undertaken into the question of whether any inference can be drawn from the woman’s menstrual cycle history prior to the conceptive intercourse. Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available already. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

E.g., do women with more or less regular cycles tend to exhibit a regular gestation period, and vice versa?

And, certainly, what evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF and/or artificial insemination pregnancies, i.e., about their documented gestation periods? Does the 38 weeks projection work? Always? If not always, can anything be correlated with any deviation?

Do women with distinctly irregular menstrual cycles tend to have non-regular gestation periods?

The complicating effect of first versus subsequent pregnancy has already been noted, of course…

Conceivably, there is no such preliminary info available, and we shall have to try and gather even these preliminary data in a systematic manner, but – no question asked, nothing learned… Public or private input would be appreciated.

Birthday, and how it relates to the bioZhena enterprise – eukairosic™ diagnostic tools

Today is a major anniversary related to the bioZhena enterprise. Namely, a round-number (and not small) birthday of the offspring whose begetting had much, if not everything, to do with the inception of the project.

The biologically educated member of the would-be parental team insisted that medical help would have to be the very last resort, as she did not wish to be poked in and subjected to the various medical procedures available in the country of the proud Albion (that, alas, no longer ruled the waves!), where this awakening was going on. The image of what she resented getting into is telling, and it’s not even the whole story.

Awakening on the part of said couple, who till then took steps to minimize or theoretically avoid getting in the family way, owing to circumstances. As in too many instances the world over, the “awakening” was left until somewhat too late. I do not wish to talk about age specifics, but you probably know that particularly female fertility (more accurately put, fecundity or fecundability) decreases starting around or even before the Christ’s age, and so – in retrospect – it was no great surprise to find that achieving pregnancy was not as simple as expected. At the time, actually, this was a great surprise…

At the time, yours truly was not an expert in the field that deals with certain practicalities of the most important aspect of life, by which many of us mean procreation, reproduction, and its management. I am referring to some insight into the practicalities on the female side of things procreative, which insight was not there at the time – but the better half knew the basic fundamental that I now delight in referencing as eukairosic.

In a nutshell, the word refers to the right time, opportune time – exactly what we are about – the strategic or “right time; the opportune point of time at which something should be done.” A window of opportunity is kairos time.

For more about this, the Wikipedia article can be recommended, at http://en.wikipedia.org/wiki/Kairos . Let’s cite: Kairos (καιρός) is an ancient Greek word meaning the “right or opportune moment,” or “God’s time” [sic; thus said – but this should say “gods’ time”]. The ancient Greeks had many gods, and two words for time, chronos and kairos. While the former refers to chronological or sequential time, the latter signifies “a time in between”, a moment of undetermined period of time in which “something” special happens. What the special something is depends on who is using the word. END QUOTE.

If you visit that article, you will probably understand why I would like to look at the possibility of adopting as our company logo QUOTE a monochrome fresco by Mantegna at Palazzo Ducale in Mantua (about 1510 C.E.) that shows a female Kairos (most probably Occasio)… UNQUOTE.

You will also appreciate that, since we are not theologians, and because “eu-“ is the Greek prefix meaning well or good or true or easy, my choice of the adjective that we want to trademark as descriptive of bioZhena’s wares is eukairosic™.

And so here, for the sake of accurate definition, is one other item from The Alphabet of bioZhena – /2007/11/28/the-alphabet-of-biozhena/

Fecundability and fecundity:

Fecundability is the probability of achieving pregnancy within one menstrual cycle – about 20% or maybe 25% in normal couples [sic; the probability depends on many factors, including age – vide infra, or see below].

Fecundity is the ability to achieve a live birth.

Fecundability is strongly influenced by the age of the partners, and it is maximal at about age 24. There is a slight decline at ages 24 – 30, and a rapid decline after age 30.

The words are derived from Latin fecundus, fecund, from the root of fetus, via Old French fecond. Fecund means fruitful in children, or prolific.

As for the eukairosic diagnostic tools, their utility goes beyond reproductive management. Due to folliculogenesis (menstrual cycling), even things such as administration of medications or certain diagnostic examinations must be performed at the right time within the menstrual cycle…

Scire quod sciendum

fecundoscitus!!! 🙂

Thus spoke the exegete and father of Barnaby and Petrushka, Vaclav Kirsner © 2007

 ‘To know what is to be known’.

Infertility and A.R.T. or Assisted Reproductive Technologies

For these and other entries, see the Alphabet of bioZhena at

/2007/11/28/the-alphabet-of-biozhena/

 

 

Infertility:

Clinical infertility is the inability of a couple to achieve a pregnancy or to carry a pregnancy to term after one year of unprotected intercourse. If the difficulty to conceive lasts less than a year, the condition is referred to as reduced fertility or sub-fertility (see the previous post at /2007/12/14/sub-fertility-or-reduced-fertility/ ). Clinical infertility is classified further into male infertility, female infertility, couple infertility, and unexplained infertility. Studies have shown that in the past 50 years the quality and quantity of sperm has dropped by 42% and 50% respectively. In the past 20 years the decrease in sperm counts has occurred at a rate of 2% annually. For further information refer to Xeno-estrogens (see the Alphabet of bioZhena at /2007/11/28/the-alphabet-of-biozhena/ and the web reference therein).

In the U.S. alone, of the 6.7 million women with fertility problems in 1995, 42% had received some form of infertility services. The most common services were advice and diagnostic tests, medical help to prevent miscarriage, and drugs to induce ovulation [Fam. Plann. Perspect. 2000 May-Jun;32(3):132-7].

 

 

 

A Glossary of Infertility Terms and Acronyms published by the InterNational Council on Infertility Information Dissemination is available at http://www.inciid.org/glossary.html .

 

 

ART or Assisted Reproductive Technologies:

 

Also referred to sometimes colloquially as the “heroic procedures”, they are used to treat infertility patients. ART refers to all techniques involving direct retrieval of oocytes (eggs) from the ovary. They are: artificial insemination (AI), IVF (in vitro fertilization), TET (tubal embryo transfer), ZIFT (zygote intra-fallopian transfer), GIFT (gamete intra-fallopian transfer), ICSI (intra-cytoplasmic sperm injection), blastocyst transfer and other infertility treatments, such as IUI (intra-uterine insemination), assisted hatching (AZH), and immature oocyte maturation (IOM).

Web reference: http://www.ebiztechnet.com/cgi-bin/getit/links/Health/Reproductive_Health/Infertility/Education/Assisted_Reproductive_Technologies/

 

 

Sub-fertility or Reduced Fertility

For this and other entries, see the Alphabet of bioZhena at

/2007/11/28/the-alphabet-of-biozhena/

Subfertility (THE INITIAL TARGET OF BIOZHENA):

A state of less than normal fertility but not as bad as clinical infertility. Also called reduced fertility, it refers to the inability to conceive for more than about 4 months but not more than a year (which then becomes classified as clinical infertility, the inability to conceive after a year of unprotected intercourse). It is estimated that as many as one in six couples (17%) have difficulty in conceiving the number of children they want when they want them.

Again: Research suggests that between 14 and 17 percent of couples are affected by subfertility at some time during their reproductive lives. In fact, only eight out of 10 couples trying for a baby do get pregnant within 12 months. For approximately 10 percent of couples, pregnancy will still not have occurred after two years (clinical infertility). Sometimes the label of subfertility is used for couples who have had regular unprotected sexual intercourse for all of two years without conception taking place. This is a reflection of the fact that subfertility is becoming more and more commonplace.

According to one source ( http://www.womens-health.co.uk/ ), even for a healthy fertile couple, the ‘per month’ success rate (conception rate) is only around 15-20%, “so it is not at all uncommon to take some months to conceive”. Overall, around 70% of couples will have conceived by 6 months (a 30% subfertility rate). 85% conceive within 12 months (a 15% subfertility rate, “for the less impatient”). And 95% will be pregnant after 2 years of trying (technically, this is a conservatively estimated infertility rate of 5% – c.f. the 10% referenced above; or, this statistic might be perhaps considered the subfertility rate for the angelically patient). The monthly success rate in this population is 8%, and this statistic drops progressively as time goes on.

As for possible causes of difficulty to conceive, alcohol consumption, even in small amounts, can reduce a woman’s chance of conceiving by more than 50 percent, and smoking “…drastically reduced fertility in our sample”, as wrote a team from the Baltimore-based Health Care Financing Administration, in a report published in “Fertility and Sterility” (1998; 70: 632-637).

In terms of help, many people believe that fertility drugs, even when effective, remove conception from the intimate relationship between the partners, which means that it is to some extent beyond their control. Besides this loss of control, there are drawbacks and disadvantages to all forms of medically assisted conception. Some of them have potentially serious long-term effects. Consequently, many couples prefer to avoid these risks.

Women who describe overcoming infertility with the help of alternative therapists went to them because they had been offered drugs to induce ovulation but were reluctant to take them, when they learned of the possible side effects. Disturbing reports have appeared about the long-term as well as short-term effects of assisted conception. Increased miscarriage levels and premature and multiple births are not only very distressing but have considerable cost implications, both personally and societally (i.e., this is a public health issue). Babies born prematurely, or in multiple births, are at a disadvantage from the start. There are also some reports of increased rates of ovarian cancer in women who have taken fertility drugs, and of cancer in the babies of mothers who have had ovulation induced by drugs.

Subfertile couples are naturally interested in methods and tools that can help them to overcome the difficulty to conceive. The endocrinologist professor Brown may be quoted: “Failing to conceive when wanted is stressful and therefore favours infertility. It should be remembered that, apart from a few conditions such as blocked fallopian tubes, absent sperm and continued anovulation, most couples will conceive eventually without help. However, the modern expectation is one of immediate results, and the main function of assisted reproduction techniques is therefore to shorten the waiting time for conception.” To which we would add that bioZhena aims to offer a more affordable and safer alternative.

With the mentioned statistics of the fertile-age women suffering from the subfertility problem, this is a truly large opportunity in a constantly renewing and growing market. We are talking about 9 or 10 or even 18 million women in the USA alone – or quite possibly many more, taking into account all the impatience and demand for instant gratification in people today; plus about 50% of the 10 million of clinically infertile US couples, that is those who cannot afford the very costly ART treatments. [A.R.T. = Assisted Reproductive Technologies.]

This is the initial, early-stage, mission of bioZhena Corporation: To provide a definitive timing aid to couples experiencing difficulties in conceiving a baby. See also the entry for the Ovulona, where it is explained that, in this situation of reduced fertility, the basic problem is the proper timing of the intercourse.

 

The Ovulona™

This is the putative trade name of the women’s health version of the bioZhena core product, as opposed to the animal version (see the BioMeter entry in the Alphabet of bioZhena). An earlier prototype was once referred to as the Ovulon – at the time when it received its FDA 510k clearance – but the feminine-gender form of the name is surely more appropriate (with the a at the end of the name, the Ovulona).

Now a citation:

A remarkable property of the cervix is the extreme sensitivity to the effect of estrogen and progestogens. Changes in the composition and properties of cervical secretions have been used for many years as an in vivo biologic assay for sex steroids.

How well put, on page 564 of the compendium “Human Reproduction: Conception and Contraception”, edited by E.S.E. Hafez and T.N. Evans, Harper & Row Publishers, 1973.

In the Epilogue, Professor Hafez further stated that “…the fertile period of the menstrual cycle is not more than 4 days, and probably less”.

He also said: “Unfortunately, accurate detection of this fertile period is difficult, due to individual variation in the length of the menstrual cycle and frequency of ovulation, and to the absence of clinical signs of ovulation.”

We cite him here because the books edited by Hafez were explored at the inception of this project, and because all these referenced facts of life were the premises for the beginning of the project and for the development of the intellectual property.

You may almost view the cited reference to the remarkable property of the cervix as a possible definition of the bioZhena innovation. Definition of the basic primary application of the invention. Accurate detection of the fertile period is the operative phrase, and it is what eludes the various alternative, already marketed, methods and products. I refer to them as the peri-ovulation methods. We all know that those products have not solved the fundamental diagnostic need of woman- or humankind. 

We have, which is why we can talk about a non-hormonal, non-chemical, non-barrier, non-surgical pregnancy avoidance as well as pregnancy aiding – by timing intercourse with respect to ovulation. Here is a schematic diagram of how (stripped of precision):

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For more on how this will work for you, view the slide The three-day fertile window how-to (to exit the slide, just click on it. You can also view this by clicking on the image below).

In this animation, with the “try for” indicators, we reference the outcome of a France et al. study of fetal gender pre-selection superimposed on the menstrual cyclic profile generated by our device in a small clinical trial. Morning and evening monitored data were compared to BBT temperature data of the same subject of the pilot study. You might notice how the data suggests the progress of folliculogenesis between the AM and the PM hours.

Click image to view The three-day fertile window how-to (to exit the slide, just click on it).

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And now, let me insert a fast-forward from the time this post was written in December 2007.

Here is the shortest possible summary introduction of the Ovulona device for women’s personal tracking of fertility with concurrently screening cervical health. 3 slides with some links https://biozhena.files.wordpress.com/2018/03/ovulona-from-startup-version-to-cervical-ring-implementation.pps

For further particulars, try this bioZhena intro in 10 mostly narrated slides https://biozhena.files.wordpress.com/2016/12/new-set-v7-narrated-slides-edec16.pps

How the Ovulona^TM will help women’s physicians to better help their patients is shown in this slide: https://www.linkedin.com/feed/update/urn:li:activity:6489235834502463488

Cervical health screening, pregnancy monitoring and other applications will be introduced while generating revenues with the already FDA-cleared minimum-value application of the core Ovulona^TM product.

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The Smart Ovulona™ will interpret the daily measurement data for display on the screen of the device in plain language such as FERTILE DAY 1 or PREGNANCY DETECTED or SEE DOCTOR ABOUT CERVIX.

But that is only the beginning. The fertile window determination is the basic or primary application of the Ovulona, our core product with numerous diagnostic ramifications within the bioZhena Fertility and Health Awareness System™.

The various topics for utilization of the Ovulona are discussed in the posts of this blog, reflecting the broad applicability of our technology of FOLLICULOGENESIS IN VIVO™ beyond reproductive management. See, for example, Much in women’s health revolves around folliculogenesis – from teen age to peri-menopause .

Although we do not disclose and I do not blog about all the significant uses of at-home monitoring of the cervix uteri, another example is discussed in the post “Far more than a tool for getting pregnant and for pregnancy avoidance. (On symptometric monitoring correlated with folliculogenesis: Why it is essential for effective diagnosis in women’s healthcare)”. This is a hint at how the technology can help physicians to better help their female patients.

Explore the blog’s Table of Contents. In one of the articles you will read how another Emeritus Professor (Erik Odeblad) influenced the inception and development of the bioZhena project by his work, which influence was memorably captured in his apt saying,

“The cervix is a precision organ as complex as the eye”.

There you have it, the basic tenets of bioZhena and our focus on the cervix uteri.

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For further particulars, read on.

The origination of the Ovulona (and/or BioMeter) technology was a response to a basic human need on the part of a husband and wife pair of scientists. On the one hand, we struggled with the newly experienced pain of an apparently sterile marriage. But we also realized that we were conceivably in a position to help ourselves by combining our respective professional knowledge resources.

It all goes back to the postulate, by the ever so pragmatic female of the species, that before any of the more or less bothersome medical procedures should be undertaken, the basic problem of proper timing of the conceptive intercourse (i.e. of insemination) must be conquered.

This is how the project came about, and everything else followed. (The reader will understand that the postulated principle holds for every couple.) And let’s be explicit about the fact that “everything else” includes not only the broad applicability of the ensuing tissue biosensor.

The said “everything else” also includes the realization that, by interfacing with the cervix, we are monitoring folliculogenesis (the maturation of the egg in the ovarian follicle). And it includes, most importantly, the crucial capability to detect ovulation and not just predicting it. Last but not least, “everything else” also includes the appreciation of the unprecedented impact the monitoring of fertility status via the uterine cervix has on the quality and broad applicability of the menstrual cycle profile.

Better than so many words, let me offer you a picture, a shorthand representation of what the bioZhena ectocervix monitor is involved with, how the menstrual cycle profile records come about – the neuroendocrinological mechanism. Do note well the words in lieu of the figure caption.

Here are 447 words in lieu of a caption for the composite image:

The ovulographic monitoring of folliculogenesis in vivo is believed to capture the fine-tuning effects on folliculogenesis of the direct neural control via ovarian and uterine innervation and the acute effects of local (autocrine and paracrine) modulatory actions.

Neither of those effects can be detected by the systemic peripheral variables such as the BBT or the urinary levels of hormones monitored by the commercially available home-use technologies.

See https://biozhena.files.wordpress.com/2019/01/Single-slide-How-the-Ovulona-will-help-physicians.pdf for how this will help physicians to better help their female patients. See how Ovulona anticipates failure to ovulate in a healthy woman, and how Ovulona detects delayed ovulations in asynchronous cycles that happen to many healthy women. These occurrences are where the neurological effects are suspected to play a role.

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Although we could not really be clear about this until Chiara Benedetto, M.D. sent us the results of measurements performed with our early prototypes by her carefully selected baseline subjects, the Ovulona provides not only a short-term anticipation of ovulation but also an earlier long-term prediction signal.

This was subsequently confirmed by another proof-of-concept study with non-baseline subjects at the Natural Family Planning clinic at Marquette University (Wisconsin – Dr. Richard Fehring and associates). See the Fehring and Schlaff paper with a Note about further insight into the published results.

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The cyclic profile features are discussed in the Post Script, below.

To be clear, the long-term predictive peak has no counterpart among the various other methods of fertility monitoring. Its position ahead of ovulation apparently depends on the rate of maturation of the dominant follicle in the given menstrual cycle, and it correlates with the length of the menstrual cycle.The other methods predicting ovulation all monitor hormone markers in general circulation (after clearance into other body fluids), which is too remote, indirect, hence the no counterpart statement of fact.

None of this would have been apparent from the early in-house longitudinal study, since the study involved a non-baseline subject (and then another). In non-baseline cycles, which are common in real life, even the luteal (post-ovulation) phase quite often is not the theoretical 14 days long… and various other deviations occur from the “ideal” (simplified) case descriptions found in medical textbooks.

Data to date indicate that the long-term warning of the upcoming ovulation event occurs sufficiently early for the practice of natural family planning (NFP). Consequently, we are in a position to claim progress over the 1973 statement in the Hafez Epilogue, which stated that “the long-term prediction of ovulation by at least 6 days seems to be difficult and, as yet, unsolved” (loc. cit. page 711).

The capability to anticipate ovulation well in advance, and to then detect ovulation independently of the predictive signals, is unique to the bioZhena technology.

This unique capability results from the mode of action, further discussed in the Alphabet of bioZhena under Modus operandi (MO). See also under Mysterious conceptions – or the non-existence thereof. From the MO also follows the broad applicability of the technology.

This broad applicability is another feature that distinguishes the Ovulona from any other product addressing fertility status and, as they in fact do, merely estimating (guessing at) ovulation.

For a potential impact of the technology on public health, see in the Alphabet under Sexually transmitted diseases, and also under Cervical cancer and under Smoking. You can also find articles on these topics in this blog’s Table of Contents (TOC). The TOC is clickable and provides descriptive snippets about the blog articles. As an example, see the blog post “Smoking affects the menstrual cyclic profile as captured by the Ovulona™, monitoring might help with smoking-cessation” .

It could be argued that the greatest aspect of the bioZhena project is the idea of introducing – via the affordable personal fertility monitoring method – a general, routinely usable, women’s health tracking and diagnostic tool, with the potential to impact on several important areas of public health. We have every intention to make this argument, and we plan to put it into practice – with support of a well-matched investor. That is why the plan to transform the Ovulona into the (semi) permanently worn telemetric cervical ring.

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Post script

Here is a larger, easier to read, rendition of the Figure with the data (choose either a silent graph or a narrated animation):

Three baseline cycles from Turin study and/or the same as an annotated slide narrated by yours truly

The cyclic pattern exhibits a number of well defined peaks and troughs: The first repeatable feature is the first post-menstruation minimum occurring typically on day 6, 7, or 8 (driven by the selection of the dominant follicle). The signal then rises to a maximum (the long-term predictive peak), which is driven by the maturation of the dominant follicle.

At this point I share with you the explanation of the long-term predictive peak by reference to the picture of the baseline cycles that we are now well familiar with. The picture is annotated with labels and short-hand elucidation of the features under discussion.

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For better legibility, click the image, view a slide show version.          The URL is: https://biozhena.files.wordpress.com/2016/12/wealth-of-info-elucidation-of-domin-folli-peak-3-slides.pps

 R… Recruitment on days 1 to 5 ± 1 (data captured usually only after blood flow – due to hygiene concerns).

S… Selection on day  6 ± 1.

GC+TC E2up… Dominant Follicle Maturation: Granulosa and Theca Cells produced Estradiol  (E2) rises, which drives the signal up; Dominant Follicle also initiates expression of LH Receptors.

GC P4up… After the appearance of LH Receptors, the preovulatory Granulosa Cells secrete Progesterone (P4), which drives the signal down. (That’s also why the ovulation marker is a trough, the lowest minimum in the menstrual cyclic profile.)

Ref.: Page 39 of 23rd Edition of Williams OBSTETRICS © 2010, 2005, 2001 by The McGraw-Hill Companies, Inc. (www.gums.ac.ir/Upload/Modules/Contents/asset39/williams23.pdf)

Above: Elucidation of the long-term ovulation-predictive dominant follicle peak (December 2016)

The long-term predictive dominant follicle peak is followed by the usually narrow short-term predictive peak, which falls off directly into the trough of the ovulation marker, the lowest reading of the cycle. We have found the ovulation-marker minimum to correlate with urinary LH and FSH peaks, and we view the marker to be an effect of the steroid hormone switch that occurs at ovulation (estrogen to progesterone dominance).

Note that the corresponding basal body temperature (BBT) curve rises, to the post-ovulatory higher level, after the ovulation marker. This indicates, to the extent that the BBT can be relied on, that ovulation had, indeed, occurred. The planned sonographic (ultrasound) investigations will confirm this correlation with a better accuracy.

The post-ovulation (luteal phase) peaks and valleys have only recently been interpreted as due to the follicular waves (preparing for the next menstrual cycle). The follicular waves are a relatively recent discovery in women [Baerwald AR, Adams GP, Pierson RA, Fertil. Steril. 2003 Jul;80(1):116-22, “A new model for ovarian follicular development during the human menstrual cycle”], which now adds a diagnostic usefulness to the luteal-phase part of our cyclic profile – for example re: menopause, aging, which is a use of the waves invoked by the cited authors.

Our understanding of the implication for early detection of pregnancy came in due course. Very early detection, essentially instant – no waiting for two weeks for the absent menstrual bleeding and for a detectable concentration of hCG in the urine!

See https://biozhena.wordpress.com/2010/11/11/instant-detection-of-pregnancy-and-of-early-pregnancy-loss-epl-the-adversary-of-trying-to-conceive-ttc-especially-after-age-25/ for the article “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

Early Pregnancy Loss (EPL) is also known as stillbirth or miscarriage, or early embryonic mortality, and the Ovulona™ will enable the user to try conceiving again as soon as possible, in order to avoid recurrent EPL miscarriage (since it is now known that the sooner conception occurs after the EPL, the better the chance of success).

Should you wish to talk with me on the phone or via Skype, please email me first to schedule the call. My email is: vaclav at biozhena dot com

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BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN

Far more than a tool to aid achieving and avoiding pregnancy

In the early years of the project, I published here a modestly formulated version of bioZhena’s vision statement. That was before a female OBGYN physician joined the team and together we broadened the vision and mission.

With the “Ambassador for the Vagina” it became plausible to fully explore the broad applicability of the technology, and to plan pregnancy monitoring and the transformation of the daily-inserted Ovulona™ into the semi-permanently worn telemetric cervical ring version that Kim the OBGYN named the Halo™.

The Ovulona™ and logo

For healthcare providers the Ovulograph™, and the Halo™ cervical ring for all women

Our vision is to create a product that practically every woman will want to use. The woman of the 21st century is envisaged to become accustomed to using her daily Ovulona and/or Halo self-check about as routinely as she is using her toothbrush.

It is pertinent to note that a May 2017 Human Factors in Computing Systems study found that the smartphone apps that track menstrual cycles “often disappoint users with a lack of accuracy… and an emphasis on pink and flowery form over function and customization”. Significantly, too, “teenage girls were relying on smartphone apps as their primary form of birth control”. Such evidence indicates that the market is primed for the bioZhena technology breakthrough.

The Ovulona™/Halo™ will be useful to the point of becoming an essential tool of women’s health management, both at home and, when appropriate, via the Ovulograph™, for the provider in the doctor’s office – and for the payer, too. Accordingly, the Ovulona will be supremely user-friendly and affordable for everyone.

See and listen to the slides in the link at the end of the post.

 

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Go to New mostly narrated slides 2017

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The Alphabet of bioZhena — Abeceda bioŽeny

THE ALPHABET OF BIOZHENA WITH CLICKABLE TABLE OF CONTENTS

The Alphabet of bioZhena

A glossary of biomedical terms for bioZhena Corporation

The glossary-and-primer of bioZhena is attached; click on one of the links above.

The glossary is just that! For more details with illustrations and more substantial treatment of certain topics, please go to the the blog, starting perhaps with the Table of Contents . Or try one of the two About pages – one about the blogger and the issues covered here , and the other About bioZhena – tech pitch . See if both these pages include the link to a quick pictorial summary of the bioZhena project, called Tweetroducing bioZhena in 8 slides = https://biozhena.files.wordpress.com/2020/01/tweetroducing-biozhena-in-8-slides-e19e2on011820.pps

In THE ALPHABET we expand on – and explain the meaning of – the one brief sentence: We have invented the new technology of ovulography™, fundamental to women’s health and lifestyle.

Ovulography is bioZhena’s proprietary technology for monitoring folliculogenesis in vivo. To tell the woman user, which are the three days when she can become pregnant (and the rest of the month when she cannot). And there is more, much more, which is what THE ALPHABET OF BIOZHENA is about. As is the whole of bioZhena’s Weblog .

This glossary/primer of bioZhena Corporation is no Alphabet of Ben Sira — an anonymous work, which has been dated anywhere from the seventh to the eleventh century, and which tells the story of the conception, birth, and early education of the prophet Ben Sira.

There were twenty-two stories (mimicking the twenty-two letters of the Hebrew alphabet) to answer the questions posed by the Babylonian king Nebuchadnezzar. Apart from being notable for the story of Lilith, the primordial first wife of Adam, what makes this ancient text particularly unique and fascinating is its irreverent tone …And, we get to learn of the angels who are in charge of medicine: Snvi, Snsvi, and Smnglof!

For more information on the ancient and irreverent Alphabet of Ben Sira, go to http://www.google.com/search?q=Alphabet%20of%20Ben%20Sira !

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And now, as the ancients would say, remotum joco (roughly, “joking aside”):

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A simple description and pictorial representation of the female reproductive organs is available at the American Medical Association’s web site “Atlas of the Body: Female Reproductive Organs”: http://www.medem.com/MedLb/article_detaillb.cfm?article_ID=ZZZ8QKJ56JC&sub_cat=2

A more detailed treatment of Sexual Reproduction in Humans is given in http://www.ultranet.com/~jkimball/BiologyPages/S/Sexual_Reproduction.html

For a particularly enjoyable, stimulating and informative source on the intimate geography of womanhood, reach for Natalie Angier’s Pulitzer Prize winning book “Woman – An Intimate Geography”, Houghton Mifflin Company, 1999, ISBN 0-395-69130-3. An excellent background read for the appreciation of bioZhena. But read Mysterious conceptions, under M.

For all that, go to the attached Alphabet of bioZhena file: The Alphabet of bioZhena (glossary/primer with clickable table of contents in PDF format).