Archive for the ‘1’ Category

The fallacy of ovulation calculators, calendars and circulating-hormone detectors

February 13, 2012

Don’t let them lead you by the nose with likely this and probable that! You need to know for sure.

When it comes to the crucial timing of ovulation, it is astonishing to see the fallacies and delusions propagated on the web – and that this includes even certain generally respected mainstream sources. How they declare, for example: If you’re trying to get pregnant, use this tool to find out when you likely ovulate and are most fertile.

Never mind that “most fertile” makes absolutely no sense because there is no such thing as a little fertile, more fertile and most fertile!

Ladies (and teenage young ladies included!), you either are fertile today or you are not: You either can conceive today or not.

It is either or.

You either are fertile today or you are not. It is not a little bit fertile, or more fertile, or most fertile. Like, you cannot be a little bit pregnant… you either are, or you are not.

Besides which, if you want to conceive a pregnancy, you must know with certainty that ovulation happens when you try to conceive – not merely that it is likely to happen. Unless you are reproductively ill or menopausal, it is always likely to happen at some point but the mere likelihood is not very helpful. Conception absolutely requires ovulation so that the released (ovulated) egg has a chance to be fertilized.

You must have a way of detecting ovulation at home and, based on that instrumentally recorded information, we will also help you with the Expected Date of Delivery (EDD), because that is how it works. Not the LMP (Last Menstrual Period) but the date of the conceptive ovulation — that’s the ovulation with which you became pregnant because your ovulated egg became fertilized. The date of ovulation is the date from which the EDD must be computed.

Ovulation caught on camera

Ovulation caught on camera by Dr. Donnez – impressive but not a practical method of detecting ovulation

Fast forward to the principle that’s behind the take-home message of this post and that’s systematically arrived at by the end of this post:

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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To be blunt about the language of “likely ovulate” and “most fertile”: Such language simply reflects their inability to be definitive about it – and they therefore resort to guesstimating ovulation, calling it a calculation.

Numerous websites proffer their ovulation calculators when you search online for “ovulation”. A free, printable ovulation calendar and ovulation calculator to help you…, ovulation calculator can help you find the best time to conceive (as if there was some worse time when to conceive!), a calculator to generate your ovulation calendar and determine the best time…, our free Ovulation Calendar helps you predict your most fertile time of the month (ovulation) so that you can achieve pregnancy. Etc.

Notably and significantly, they do NOT promote this for natural (behavioral) pregnancy avoidance (birth control) but only as a tool for assisting conception – as if these were not the two sides of the same coin. They do not because they would get into trouble if they did.

A common approach relies on detecting, in a woman’s urine, the luteinizing hormone (LH) that typically surges on the ovulation day. The LH surge (sharp narrow peak in LH concentration) occurs a few hours before ovulation. Because that is really too late for anticipating ovulation, a related but more sophisticated fertility monitor additionally detects also a metabolite of estrogen, i.e., another hormone, which anticipates the LH surge by about a day.

The worst flaw of systemic hormone monitoring

Fundamentally the most serious detriment is the fact that ovulation as such is not detected by said fertility device or any other such available in the marketplace. Ovulation is merely assumed to occur some hours after the LH surge – but the surge of the LH hormone is merely a trigger signal sent by the brain to the ovary. It says, “ovary, let go of the ovum in our dominant follicle”, but it does not say that the ovary in fact did (or does).

This is a fundamental flaw because ovulation is known to fail to occur in approximately 20% of the follicles. Those follicles, triggered by the LH, undergo the cyclic event of follicle rupture but, despite the rupture, the egg does not come out – there is no ovulation.

Human ovulation caught on camera

In 20% of LH-triggered cases, the egg is not released so ovulation, as photographed here by Dr. Donnez, does not occur

Ovulation also fails to occur with another type of follicles, the so-called luteinized unruptured follicles. Yet, the LH surge can be seen in either case, and is therefore a false indicator.

Furthermore, when stress causes a delay of ovulation or absence of ovulation despite the LH surge signal (signal from the brain to the ovary), this cannot be detected and handled by the urinary hormone-based approach. As you can imagine, with our stressful lifestyle and environment, this is a very serious flaw that results in many disappointments. Our technology will make a big difference in managing the situation.

George Condo - Field of Figures

George Condo – Field of Figures sold for $450,000 at Skarstedt Gallery’s booth Published: June 14, 2011

Since, unlike our Ovulona™ Smart Sensor™ technology, their method depends on biochemical reagents and since the supply of the reagents is limited, their product’s user has to estimate on which day of her menstrual cycle she should start using the hormone-monitoring device when peeing into a cup. She does the estimating based on her previous menstrual cycle(s) as though the length and the timing of the present menstrual cycle were the same as in her previous cycle(s). Alas, that’s not so. Because of the variable lengths of successive cycles in most women, this is a weak feature in their design (even though they are getting away with it).

A key practical problem of the referenced 2-hormone device (the Clearblue® Fertility Monitor) is that the monitored urinary concentration of the estrogen metabolite E3G peaks only about 12 to 24 hours prior to the LH surge. This is not early enough to serve as a marker of the beginning of the fertile phase.

Fertile day 1 not identified

Their research or marketing literature may claim that “a sustained rise in E3G can be used to identify the start of the fertile phase”, referring to the slow gradual increase that eventually becomes the peak of E3G concentration. However, the idea to use an ill-defined rise – rather than the peak in the cyclic profile of the estrogen metabolite – is not a viable solution to the fertile window problem.

Even if the ill-defined E3G rise in the urine were correlated with a clearly defined stage of the egg development towards ovulation, a serious problem is that the rate of the E3G rise differs from cycle to cycle, as do the blood concentrations of E3G. The initially slow increase of the E3G concentration in the urine proceeds at different rates in different cycles, not only at different rates in different women. The E3G rise cannot be predictably associated with the beginning of the fertile period, and it cannot serve as a marker.

Hypothalamus-Pituitary-Gonad Feedback Loop

Schematic diagram of interaction between the LH and FSH hormone-generating glands in the brain (hypothalamus and pituitary) and those of the ovary (female gonad) generating estrogen and progesterone

The reasons are as follows:

1. Estrogen is known to have both stimulatory and inhibitory effects on LH secretion and, to be effective as a stimulant, it must rise to its peak levels (> 150 to 200 pg/ml) and must remain elevated for at least 36 hours [J. Hotchkiss and E. Knobil in E.Y. Adashi, J.A. Rock and Z. Rosenwaks, editors: Reproductive Endocrinology, Surgery and Technology, Lippincott-Raven Publishers, 1996].

In fact, the E3G rise indicates something else:

2. The E3G profile does not reflect the local interplay of estrogen with progesterone because it only reflects clearance of one of at least 10 metabolites of estrogen from peripheral blood circulation into the urine, after oxidative conversion in the liver.

Whatever the rate of this clearance process in the given woman in the given menstrual cycle, there are “local mechanisms due to which the quantification of ovarian steroids in peripheral blood or in urine is rendered interesting but of little value in predicting the genital end-organ effect” [C.J. Verco, in A.M. Siegler, editor: The Fallopian Tube. Basic Studies and Clinical Contributions, Futura Publishing Company, 1986].

The decades old problem is fundamental

This makes for the same basic flaw as that suffered by other monitors of peripheral hormones whether the hormone be progesterone (BBT monitoring) or estrogen (conductivity of saliva or of vaginal fluids).

Thus, the 2-hormone approach is in the end as inaccurate as the other LH-detecting techniques (the OPKs, Ovulation Predictor Kits). Therefore, like the other hormone monitoring methods, it cannot be approved and proffered for pregnancy avoidance since the failure rate would be unacceptably high. In fact, a law suit ensued in England, when the original developer company did sell the LH-and-estrogen monitor as a “contraceptive system”, and a number of unintended pregnancies resulted to the users.

See also below, under “Smart phone apps with the BBT?” the link about Natural Cycles – the app that got regulatory approval for contraception after their clinical trial with women who purchased the app because they believed they had “regular cycles” of constant cycle length.  Not surprisingly, problems and unwanted pregnancies ensued.

The fundamental point is this: The effects of the local and acute regulatory mechanisms (referenced under 2 just above) remain undetected by the old techniques that work with the peripheral biomarker variables.

Ovarian vein-to-artery exchange of steroids, prostaglandins and other bioactive substances is a local transfer mechanism which enables local regulation of ovarian, tubal and uterine functions. The local, as opposed to peripheral, blood concentrations of the steroid hormones are also believed to work with the innervation of the female genital tract (the cervix in particular).

The effects of these local and acute regulatory mechanisms remain undetected by the old so-called prior art techniques that work with peripheral biomarker variables. In contrast, our Ovulona™ detects them – via the cervix, the natural monitor of the female reproductive system.

Gustav Klimt - Medicine mural (complete view)

Gustav Klimt – Medicine mural – Klimt’s primary subject was the female body

The flawed assumption of similar timing of menstrual cyclic events from one cycle to another has been a problem for the BBT and the BBT thermometers. Since the late sixties, the microprocessor technology has been applied by a number of people to the well-tried basal body temperature [BBT] approach to family planning that was originally hoped to work for pregnancy avoidance.

Smart phone apps with the BBT?

The BBT approach is no longer recognized as medically valid even if it may be acceptable to some of the older physicians, and to the younger buyers of an expensive microcomputerized BBT monitor offered from Europe and/or to the users of the more recent smart phone apps based on BBT monitoring.

This is because the so-called basal body temperature is a systemic variable that reflects, among other things, progesterone rise in peripheral blood after ovulation, usually one or two days later.  It is a very indirect and non-specific biomarker. Even though in some women in some cycles a little-understood dip in the temperature graph may apparently be observed one day before the temperature rise, it is clear that the BBT method is of little value due to its lack of predictive capability and due to its fundamental unreliability. The BBT-rise data is known to have a large error bar since the rise can occur from 3 days before to 3 days after ovulation.

For a more detailed critique of the BBT monitoring approach and a rebuttal of a particular European product, peruse Critique of BBT monitoring – DuoFertility rebuttal. Also read a note on 3 things that differentiate our technique from the smartphone apps and particularly the most recent, Natural Cycles .

Briefly: Tracking systemic effects (hormones in circulation) is not good enough for fertility status determination, especially if the purpose is pregnancy avoidance.

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Purveyors of the old “prior art” technologies get away with it because of the high demand for any help with the serious and growing problem of sub-fertility, more commonly called trying-to-conceive or difficult getting pregnant. When the purveyors publish anecdotal evidence of “efficacy” in the form of thank-you letters from women who did achieve pregnancy, we should keep in mind that the women received help in focusing on trying to hit the fertile period regardless of whether the given technology actually did work or not.

If any of the “prior art” did work reliably, it would be used as a pregnancy-avoidance tool, which is not the case (with the one exception noted above, a reservation included suggesting that only women with self-assessed regular cycles opted to buy the BBT-and-calendar based app with its 11 “unsafe” days offered to the user instead of the true fertile window).

Venus, Cupid, Folly, and Time (also called An Allegory of Venus and Cupid and A Triumph of Venus) is an allegorical painting by the Florentine artist Agnolo Bronzino. It is now in the National Gallery, London. Artist     Agnolo Bronzino Year     circa 1545 Type     Oil on wood Dimensions     146 cm × 116 cm (57 in × 46 in) Location     National Gallery, London Its meaning, however, remains elusive. Cupid, along with his mother (Venus) and the nude putto, to the right, are all posed in a typical Mannerist figura serpentinata form. The two central figures are easily identified by their attributes as Venus and Cupid. For example, she holds the golden apple she won in the Judgement of Paris, while he sports the characteristic wings and quiver. Both figures are nude, illuminated in a radiant white light. Cupid fondles his mother's bare breast and kisses her lips. The bearded, bald figure to the upper right of the scene is believed to be Time, in view of the hourglass behind him.[2] He sweeps his arm forcefully out to his right. Again, it is difficult to interpret his gesture with any certainty The old woman rending her hair (see detail at right) has been called Jealousy—though some believe her to represent the ravaging effects of syphilis[2] (result of unwise intercourse).

Venus, Cupid, Folly, and Time (also called An Allegory of Venus and Cupid and A Triumph of Venus) is an allegorical painting by the Florentine artist Agnolo Bronzino – circa 1545.  The bearded bald figure to the upper right is believed to be Time…

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Now go see about “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25″ at 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/

And should you be an investor and/or wish to find out more, check out  Home Page of bioZhena’s Weblog

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Seven billion people – after half a century with the Pill

November 14, 2011

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

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

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

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

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

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

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

On the issue of cervical cancer, after remembering Jan Hus – and heresy

July 10, 2011

The other day I tweeted: July 6 1415 Jan #Hus was burnt at the stake in Konstanz DE for #heresy against #doctrines of #Catholic #Church http://t.co/lM1SlwF

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

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

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  AND THINK ABOUT THE BOLD-FONT STATEMENT JUST ABOVE.

Alphonse Mucha: Madonna Of The Lillies

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.

Did not receive any, unfortunately.

Meanwhile, the government’s Centers for Disease Control and Prevention – in “Reports of Health Concerns Following HPV Vaccination” http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html – states, among other things (albeit not “in real journals”):

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

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?

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

December 8, 2010

Could high prevalence of prematurity be a consequence of motherhood not being the top job held by society in high esteem? A modern paradox.

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

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].

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

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

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

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

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

Napoleon & carabiniers_in_front_of_Moscow_1812

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 age vs. crown rump length by DJR Hutchon

Gestation vs. biparietal diameter by 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). Well, look at the scatter in the data points, it’s telling.

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 https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf (or https://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

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 https://biozhena.wordpress.com/2008/01/11/about-the-edd-andor-edc-issue-and-a-request-for-input-from-readers/ .

Tomáš Císarovský  - Kukátko

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

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.

Deliveries vs. gestational ages by ultrasound scan dates

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 graph for deliveries in India would show the spontaneous labor peak earlier (272 days by one study in tropical Manipal) while a Scandinavian graph 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). As I wrote in the conclusion of the related January 11, 2008 article: It is perfectly realistic a vision that, in future, an expectant mother’s EDD and/or EDC will be assessed based on her folliculogenesis (FIV™) data.

The EDD/EDC will be computed automatically and provided by her own Ovulona Smart Sensor™. 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

Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25

November 11, 2010

Early Pregnancy Loss is also known as #stillbirth or #miscarriage, or Early Embryonic Mortality (EEM), and the Ovulona™ is a tool of evidence-based personalized medicine.

After the optimum fertility age of the early twenties, achieving motherhood gets more difficult. It becomes even more essential than 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 detection is really important, and it should be built-in, an integral part of the conception-aiding tool.

Why? Because:

1) early in pregnancy the conceived baby would be harmed by some of the medications taken by the woman, e.g. by a psychiatric medication with teratogenic effect (harmful to the fetus, causing a congenital disorder);

and 2) because of the annual 600,000 miscarriages – per CDC statistics – out of the 6 million US births, which means that at least some 10% of pregnancies are lost to early pregnancy loss (EPL), miscarriage, 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 prospective solution for managing the problem.

The Ovulona™ detects the 3 fertile days for conception, and it will also automatically detect pregnancy immediately upon conception. Similar to 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 tweet by a @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.

Honey is Sweeter than Blood by Salavador Dali, 1941

Honey is Sweeter than Blood by Salavador Dali, 1941

For a woman in her 30s who has 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://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ .

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

November 2016 review and meta-analysis (data on more than a million women): “With an Inter Pregnancy Interval of less than 6 months, the overall risk of further miscarriage and preterm delivery  were significantly reduced.”

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.

Automatic pregnancy detection is inherent in the Folliculogenesis In Vivo™ cyclic profile (follicular waves disappear).

This is a screen shot of one of my narrated slides about “what’s going on here” – view (and hear) the slide at https://biozhena.files.wordpress.com/2015/07/single-slide-unprecedented-wealth-of-info-narrated.pps.

Note specifically that: The follicular waves, which occur after ovulation [when the body prepares for the next menstrual cycle], cannot remain in place after fertilization succeeds and conception takes place [because the post-ovulation regime change is even more profound]. That is the principle of instant detection of pregnancy. As opposed to the waiting for the HPT [Home Pregnancy Test] result.

HCG or Human Chorionic Gonadotropin laboratory signature

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.

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

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.

Comment on Female sexual dysfunction treatment options

June 20, 2010

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

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

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 (https://biozhena.wordpress.com/2007/12/11/the-ovulona™ ) will do two useful things for peri-menopausal women and their physicians (https://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.: https://biozhena.wordpress.com/2007/12/18/menopause-hrt-and-biozhena/

Regards,

@bioZhena

Michelangelo, The Last Judgment, 2

Michelangelo, The Last Judgment, 2

To this, for the purpose of 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 https://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 at https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

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

March 23, 2010

Comments on a report of two studies http://www.usccb.org/prolife/issues/nfp/cmr_winter-spring09.pdf – they report on what we will call peri-ovulation methodologies.

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

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.

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.

Wassily Kandinsky - 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

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-times 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

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 https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ and in the document attached to that post, https://biozhena.files.wordpress.com/2007/12/fetal-sex-preselection-illustrated.pdf .

We subsequently showed, in https://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 (FIV) fertile window vs. old (fuzzy ovulation estimate) methods

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 [https://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

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

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/

A few more peri-vernal equinox tweets on #conceiving, #fertility, achieving #pregnancy & #baby gender contrary to Shettles

March 21, 2010

While NFP users know that fertility awareness is a must for birth control

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

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

Adam and Eve by Tamara de Lempicka - solarized

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

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 https://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

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  https://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.

Peri-vernal equinox tweets on #conceiving, #fertility status, achieving #pregnancy in the era of #infertility – “a modern epidemic”

March 20, 2010

NFP aficionados know that fertility awareness is for birth control, too

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 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 #fertilityawareness, NFP for #pregnancy and/or #birthcontrol, we have the tool for you http://to.ly/VCF — or, rather, will have, once funded. Comments? 7:19 PM Mar 16th

About the EDD and/or EDC issue, and a request for input from readers

January 11, 2008

EDD stands for Estimated Date of Delivery, while EDC stands for Estimated Date of Confinement (the time of going to hospital for the delivery, “the lying-in of a woman in childbed“).

Seasonality of Google Searches Bears Out These Thoughts And Plans

August and July, October and/or September are the months of the season of most births in the U.S. And Mums-To-Be are rather anxious about the timing of the pregnancy-to-birthing process, gestation.

Just see how, well ahead of the upcoming birth time, the interest in the search term “gestation” peaks every year in April, give or take a month. You can see it at https://www.google.com/trends/explore?date=2004-12-31%202017-01-18&geo=US&q=gestation (search terms: United States, 12/31/04 – 1/18/17, All categories, Web Search). I’ll expand on the seasonality aspect below, after I share some thoughts and plans.

The bioZhena thinking, in one brief sentence, is this: Aim to replace stochastic with deterministic, which is the purpose of our eukairosicTM diagnostic tools. Then the E in EDD and EDC will stand for EXPECTED.

‘Expected’ based on a measured data based computation, as opposed to a subjective recall based physician’s guess. Because, as I say in the very last sentence at the end of this article: Your approaching EDD and EDC are not normalized/relative like those in the statistical graph …

The medical position on the current status of obstetrics can be characterized by the following two papers.

1) Theory of obstetrics: an epidemiologic framework for justifying medically indicated early delivery

[BMC Pregnancy Childbirth. 2007 Mar 28;7:4. Joseph KS, Perinatal Epidemiology Research Unit, Department of Obstetrics & Gynaecology, Dalhousie University, Halifax, Nova Scotia, Canada]

QUOTE: Modern obstetrics is faced with a serious paradox. Obstetric practice is becoming increasingly interventionist … Whereas … mortality declines exponentially with increasing gestational duration, temporal increases in medically indicated labour induction and cesarean delivery have resulted in rising rates of preterm birth and declining rates of post-term birth. … [This] provides a theoretical justification for medically indicated early delivery and reconciles the contemporary divide between obstetric theory and obstetric practice. END QUOTE.

And 2) A re-look at the duration of human pregnancy

[Singapore Med J. 2006 Dec;47(12):1044-8. Bhat RA and Kushtagi P, Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal, India]

QUOTE: The duration of human pregnancy is arbitrarily taken as 280 days (40 weeks). Foetuses are considered to be at high risk once pregnancy goes beyond the expected date of confinement. … Conclusion: 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. It is suggested that there is a need for determining the length of gestation and to compile gestation-wise incidence of … neonatal morbidity indicators for different populations. END QUOTE.

Related medical publications are here.

I will rely on the birthing specialist, Janelle Durham, to verbalize for you the status quo in this aspect of the homo sapiens experience – below. First,

Gestation Period, Gestational Age and OvulonaTM

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age ,

” 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 women’s healthcare and self-care device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse as a part of her record of the menstrual cyclic profile. 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 use by the woman’s physician(s). And in due course (contingent on funding) the cervical ring transformation of the Ovulona will remove the need for daily insertion…

Therefore, the routine use of the Ovulona (and of the internally worn HaloTM cervical ring) 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 this context, 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 (baby-making) intercourse.

Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

Questions

Questions such as: What evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF 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?

Has anyone looked at whether there may be an effect of geography in terms of hot vs. cold climate on gestation periods of natives? And perhaps even at whether a gestation-period difference may arise in data at a well-selected locale between winter and summer deliveries (of course only natural, not “medically indicated early deliveries”)?

The complicating effect of first versus subsequent pregnancy has already been noted, of course… That evidence exists for gestational length variability with ethnicity (or race) has been noted, too:

“122,415 nulliparous women with singleton live fetuses at the time of spontaneous labour, giving birth in the former North West Thames Health Region, London, UK. Results: The median gestational age at delivery was 39 weeks in Blacks and Asians and 40 weeks in white Europeans.” [International Journal of Epidemiology 2004, Volume 33, Number 1, pp. 107-113 ].

I am happy to observe that this outcome is not counter-intuitive (because women with ancestors in hot climates seem to tend to shorter gestational age at delivery than those who can be presumed to originate from colder climate conditions).

Conceivably, such a preliminary info, which I am after here, is not forthcoming — and we shall have to try and gather even these preliminary data in a systematic manner when the time comes, but no question asked, nothing learned… Public or private input would be appreciated. (I wrote this request here in 2008.)

Although focused on the very serious complication in pregnancy, A Balancing Act: Ideal Delivery Timing & Chronic Hypertension by Eva Martin, MD is an example of the kind of information that we will need when setting out to start the adaptation of our technology to the challenge of assessing and managing EDD/EDC. Retweeting her piece, I tweeted in April 2017: This is why when the monitoring will better assess EDD/EDC >abandon old Naegele rule.

Dr. Martin has a few videos online on the subject of due dates, and here is one of them (~2 minutes): How to Calculate Your Due Date After A.R.T. –  https://www.youtube.com/watch?v=G4OCSwxTEIg  (in a nutshell: Fertilization + 266 days [38 weeks] as we already noted above, with reference to the Encyclopedia of Childhood and Adolescence).

There in any case does seem to be some, perhaps fairly good, basis for this attempt at a preparation for an introduction of a tool for definitive assessment of EDD and EDC.

Due Dates Paper by Ms. Durham

According to the due dates paper by Janelle Durham, written for Certification with Birth Education in January, 2002 , QUOTE: “some women are aware of when they ovulate, either based on formal methods and record-keeping such as daily temperature checks, or on physical symptoms such as mild pain upon ovulation, or observation of changes in vaginal mucus. Many women know the dates when conception was possible, because they know the dates when they had intercourse during their most recent menstrual cycle.

Due dates can be calculated based on these dates, but many physicians prefer to calculate it from date of last menstrual period. They may only calculate from conception date if conception was medically managed and supervised through techniques such as artificial insemination.

Based on date of last normal menstrual period.

Due dates are typically calculated based upon the date the last menstrual period began, according to the mother’s report. Naegele’s rule assumes that ovulation occurred 14 days after LMP, which is only the case for women with 28 day cycles. Some caregivers will ask their patients for a history of menstrual cycles so that they can adjust this number, as appropriate, for cycles of different lengths or irregular cycles.

It’s also important to consider: recent use of oral contraceptives, and their possible effect on ovulation date; inaccurate memory about when the last period occurred, the possibility of interpreting post-conception ‘spotting’ as a light period, and unrecognized pregnancy losses. These issues all complicate due date prediction, and it’s estimated that nearly 25% of infants who would be classified as preterm birth on the basis of the last normal menstrual period are not preterm. (Cited in Health Canada)” END QUOTE.

At this point, let me translate the one brief sentence I wrote at the top into a less specialist language. Ms. Durham shows a statistical distribution of gestation periods applicable to any woman, and that is the approach I labeled stochastic, because of its statistical nature. I admit, the word is harking back to the days of my postgrad phys chem endeavors, which were mostly endeavours at the time. 🙂 We could also say, probabilistic – two syllables longer, though!

Gestational Age at Birth vs. Weeks since LMP

http://transitiontoparenthood.com/ttp/birthed/duedatespaper.htm

Janelle Durham, for Certification with Birth Education NW. January, 2002.

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Our Goal – Your Comments

With our eurokairosicTM diagnostic tools, we generally aim to determine the right time, and in the case at hand we propose to provide for a much less fuzzy assessment of the EDD and EDC. After all, precedent exists in the A.R.T. arena, and prerequisites, too, to some extent at least.

In a nutshell: Let’s replace the LMP/Naegele-based approach with a hard data-based technique, applied to each and by each Mom individually.

Again, your comments on and/or answers to the questions above would be useful. Public or private input would be appreciated. [Private to: vaclav@biozhena.com please.]

In any case, for more on this topic see a related post published on December 8, 2010: Saint Nicholas Day, his legend, and our modern day’s prematurity, EDD calculation, gestational age, problem with LMP. We show there data from a study of more than 24.5 thousand pregnancies demonstrating that “most (71.5%) inductions done post-term (> 294 days) according to LMP dates were not post-term if ultrasound scan dates alone are used to calculate the gestational age.”

Vision

It is perfectly reasonable a vision that, in future, an expectant mother’s EDD and/or EDC will be assessed based on her folliculogenesis in vivo (FIV™) data which will include the electronic record of every sexual intercourse. The EDD/EDC will be computed automatically and provided by her own Ovulona Smart Sensor™.

So that, for example, a woman in and native to (or perhaps with ancestry from) a hot climate region might automatically obtain her EDD of 39 weeks when she electronically registers her day of intercourse on her Ovulona. Versus 40 weeks for a white European, consistent with the knowledge base noted above and assuming its validation.

No more uncertainties as in the LMP-based estimation. The bell-shape curve of distribution (such as the Janelle Durham graph above) will be replaced by personalized specifics.

Seasonality of EDC Searches on Google

On June 1, 2015 (at about the time of the year when, statistically, most American expectant mothers are about the last trimester away from their Estimated Date of Delivery and of Confinement) I add the following illustration. It appears to suggest why in May and June each year for the last 6 years there is always a noticeable increase in the viewing statistic of this blog post that you are reading. The interest in the subject of the due dates is up.

Seasonality of Search Google Trends for search term “EDC” 2009 - 2015

See the image better as Single slide – Google Trends for EDC Search 2009 – 2015 e

Check the trend for yourself by moving from the screen shot image to the actual graph online via the link http://v.gd/c2MOyR i.e. http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2078m&cmpt=q&tz= . Once online, the Google graph shows (with cursor put on data for different months) the counts of US searches for EDC in the different months. You can change the range of the time period via the Time button, and the country of interest via the Country button. The numbers represent search interest relative to the highest point on the chart. At the time of writing this, it was the number of searches in June 2014 (assigned the maximal relative value of 100).

Move the cursor along the graph to see the values for other months within the examined period. You’ll see the EDC value of 100 in June 2014; in June 2013 the US peak was at 72 counts. The worldwide trend is much like the US trend because the statistics are driven by the overwhelming majority of American searches. E.g. the May 2015 count worldwide is only higher by 7 more searches than the US value of 48; in June 2014 the worldwide count was the same 100 as the US while in June 2013 the worldwide count was 20 counts higher than the US count of 65.

That’s as of June 3, 2015. Might this change later? Well, click http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2082m&cmpt=q&tz=Etc%2FGMT%2B6 and see the graph as of September 12, 2015, which does show the June 2015 peak indubitably.

The worldwide count can be obtained via the Country button on the Explore bar in Google Trends (USA was selected here). The data are normalized, relative numbers – you can read up on it… It’s a Google algorithm.

And here now is a January 6, 2017 update of the Google Trends EDC results, showing that the June peak (in search activity for EDC) continues to be there; in June 2016 it stood at 88 while in June 2015 it was 89, as found by placing the cursor on the peak in the online graph (only one data point can be screen-printed as in the image here) – the URL is below the image:

google-trends-edc-12-31-08-to-12-31-16

https://www.google.com/trends/explore?cat=45&date=2008-12-31%202016-12-31&geo=US&q=edc

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Dear Reader,

Your approaching EDD and EDC – if indeed their coming up is the reason why you are reading this – are not normalized or relative values like those in the statistical graph

— and good luck, all the best from bioZhena!

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