Posts Tagged ‘fetal sex preselection’

What Women Know, And What They Want To Know About Their Fertility Status

October 10, 2009

There: What Women Know

Despite the many BBT charting apps and some BBT monitors, and despite the urine analyzing (or the saliva testing) products on the market, here is a fundamental fact:

There is no device in the marketplace today that would tell you, in plain English, “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy.  And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. There is no device out there that would detect (not just guess at) ovulation, which will enable you to try to conceive a girl, if that is what you wish for.

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

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

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

For more on this, go to The post on 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/

Here: What Women Want To Know

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

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

https://biozhena.files.wordpress.com/2015/09/ovulona-single-slide-3-day-fertile-window.jpg

Ovulona - single slide 3-day fertile window

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

The Smart Ovulona will display the results electronically interpreted, presented in plain language such as FERTILE DAY 1 while the raw data is stored within the device for optional use by healthcare professionals.

Primary use is for personal reproductive management – that is aiding the achievement of pregnancy, and also aiding fertility-awareness based non-invasive birth control.

But there is much more, including an automatic screening for cervical cancer, management of PMS/PMDD and management of hormone therapy, to name just a few of the applications that will come with the core technology.

We show below the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle – and compared with the woman’s basal body temperature for reference. The graphs of the measurement data produce cyclic profiles descriptive of the nuances of the monitored menstrual cycles. None of the old techniques can do that.

These cyclic profiles have important characteristics:

1. The menstrual cyclic profile has numerous repeatable features. It is an electronic signature of the menstrual cycle, which is the female 5th vital sign.

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

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

The significance of these menstrual cycle profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology.

https://biozhena.files.wordpress.com/2018/05/biozhena-corp-single-slide-3-day-window.pps Click the link or the image for a better view – an animated slide.

Fertile window for birth control

Fertile window for birth control

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

Before you go, see this, to get some sense of what is going on here:  https://biozhena.files.wordpress.com/2018/05/wealth-of-information-in-menstrual-profile-signature.jpg The link opens a larger version of the slide snapshot image.

Better still, click the next link for the animated and narrated slide:  https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps

wealth-of-information-in-menstrual-profile-signature

Note the planned use of the follicular waves for early pregnancy detection (the waves disappear; the right term for this is “instant pregnancy detection”), and monitoring for early pregnancy loss (in that unfortunate eventuality, the waves come back; it is advisable – by certain recent medical findings – that the couple should not delay trying to conceive again).

Refer to the following for more about said recent findings: original medical publication in BMJ http://to.ly/9WtG; BMJ editorial comment http://to.ly/9WtI; CNN.com article “Miscarriage? Try again ASAP, study suggests” http://ht.ly/2mlwb; bioZhena’s post http://to.ly/802p “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

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A party with an interest relevant to bioZhena Corporation can be provided with more confidential information upon request (email: vaclav@biozhena.com).

Visit https://www.linkedin.com/in/vaclavkirsner/ .

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Fetal sex preselection – illustrated

December 3, 2007

Ovulona and logo

In the document attached to this post (below), we say:

The following illustration is adapted from one of our slides. The slide indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace. The data were generated in a clinical study performed with our early prototype by an independent OBGYN academic. The data show the morning and evening cyclic profiles from one of the baseline subjects studied by the gynecologist Dr. Benedetto of the University of Turin, Italy.

This is a record of one menstrual cycle of a 30-years old woman participating in the Italian clinical test. The record shows the typical features of the Ovulona cyclic profile. In these early tests, the measurements were taken twice daily (morning and evening) in order to see if a time-of-day effect could be observed, and the BBT (Basal Body Temperature) was taken in the usual manner as a reference parameter.

Here is the slide:

The three-day fertile window how-to

The record shows that the features of the cyclic pattern – reproducible because the same features were also obtained by other women – make it possible to determine the boundaries of the fertile window. The precision is such that it allows for correlation of fertile day 1 with trying to conceive a boy, and correlating fertile day 3 (the ovulation day) with trying to conceive a girl. Correlating each of the 3 fertile days with the indicated likely gender of the baby conceived on the given day is based on the results of certain studies by other investigators (John France et al.), as referenced below.

The outcome of their clinical work is consistent with the finding a decade later – by other investigators in 2001 – that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing). The France et al. results from timed-conception birth-giving patients stand by themselves but it is nice to have available the separately produced physiological rationale that explains those results; read on.

And here is in a nutshell the clinical trial evidence for the 3-day fertile window:

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3-day window data from a study by John France et al.
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This is a re-plot of their data (from 55 births) of birth counts as a function of the cycle day, whereby the outlier data points were considered to belong, in fact, to the counts of the three days of high birth counts, the outliers having been due to their inaccurate and unreliable methods of estimating the time of ovulation. The problem will be resolved when, instead of the old imperfect methods of guesstimating ovulation, people will use our Ovulona monitor.

More details are in the attached file: Fetal sex preselection – illustrated

The file is a description of the origin (including the best clinical trial evidence available to date) of the 3-day fertile window.

The 3-day window of high conception probability is unequivocal (there is no doubt that the data show that window). The low birth counts on the flanks of this 3-day group are data point outliers due to errors in the investigators’ estimating the ovulation day.

The 3-day group of high birth counts is in the data whether we simply ignore the outliers or add them to this group. This is no unreasonable massaging of the data because the investigators’ methods of estimating ovulation timing are well known to have high error bars associated with their ovulation-day estimation.

The 3-day fertile window is also supported by evidence published in the NIH paper referenced below. The 3 days of unequivocally high probability of conception are clear in their data, which is all based on analysis of first morning urine samples for metabolites of estrogen and progesterone that they considered “highly concordant with the peak urinary concentration of luteinizing hormone (which corresponds approximately with the day of ovulation)”.

The NIH researchers (Wilcox et al.) did not consider the inaccuracy of their estimated ovulation despite their having acknowledged that their method only “approximately” assessed the timing of ovulation. Unlike France et al., they did not use more than the one method of estimating ovulation. They simply accepted that, in addition to the three days of high conception probability, their data also contained three early days of low probability of conception – as though 3 to 5 days old spermatozoa made a woman a little bit fertile, despite the 3-day maximum lifespan of the sperm.

We account for their days of low conception probabilities in the same way as above, in terms of data point outliers. A probable cause of their low conception probabilities in the early pre-ovulation days (days -5 to -3), additional to their merely approximately estimating ovulation timing, was the possible delay between the indirectly monitored systemic hormone signals and the actual ovulation. Ovulation (day 0) in their study was not detected but only assumed based on urine hormone metabolite measurements. Despite this and other flaws in their study design, the evidence of the 3 days of high conception probability is there, similar to the data of France et al.

The Wilcox et al. technique of tracking certain ovarian hormones in the urine does not monitor the complex mechanism of folliculogenesis. Any mismatch between the ovarian and the brain hormone signals goes therefore undetected, and their estimate of ovulation timing is indeed very approximate. Of the other study design flaws, let’s mention the artifice that any “intercourse recorded on a given morning was assumed to have occurred the previous day”. This incongruous assumption artificially produced the day 1 conception probability of zero.

As for their low probability data for days -5 to -3, we can consider them to be data point outliers because a pilot study with our prototypes produced evidence of ovulation delays of up to 3 days after urinary LH detection (even 4 days in one of the 21 cycle records, monitoring urinary LH, Peak mucus, and Ovulona prototype). Ref.: https://biozhena.wordpress.com/2010/03/28/folliculogenesis-in-vivo%E2%84%A2-monitoring-is-far-better-than-current-home-use-fertility-self-help-tools/

Further, in support of the fetal gender preselection based on fertilization timing, a “statistically significant lower proportion of male births among conceptions that occur during the most fertile time of the cycle”, meaning at or near estimated ovulation, was found in a 1991 Johns Hopkins University meta-analysis of six NFP studies, cited below in the References.

Similar conclusion came out of an assessment of medical literature in 1989: “More females are conceived when coitus occurs relatively close to ovulation…”. The view of the cited group at University of Washington School of Medicine, Seattle was that the “influence of coital timing on the sex ratio is overall quite subtle and is not a practical method to alter the sex ratio for individual couples” (for citation see References). We would say that our purpose is to offer a means with which to make it practical…

Besides the referenced reviews of clinical outcomes, there is the above-mentioned evidence from a premier infertility treatment institute (G. Hodgen et al., see References) that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing).

Therefore, intercourse two days before ovulation favors the conception of a boy because only the male Y-chromosome bearing spermatozoa live that long. The male sperm live long enough to be available for fertilization when ovulation releases the ovum (egg) from the ovulating ovarian follicle.

Whereas the female X-chromosome bearing spermatozoa have a chance to produce a baby girl only if intercourse takes place on the day of ovulation, because of their short lifespan.

Note that these are probabilistic indications, hence the labeling “try for a boy” and “try for a girl”. Certainly, we would not say that on the given day you will definitely conceive as indicated.

That should be no surprise because you know that conception is a matter of chance, a probabilistic matter, in the first place. More on this topic of conception probability is in the post Difficult conception tied to pregnancy complications – addressed.

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References

France et al. paper with data on fetal sex pre-selection, 3-day fertile window:

J.T. France, F.M. Graham, L. Gosling, P. Hair and B.S. Knox, “Characteristics of natural conception cycles occurring in a prospective study of sex preselection: fertility awareness symptoms, hormone levels, sperm survival, and pregnancy outcome”, International Journal of Fertility 37 (4), 224 – 255, 1992.

Wilcox et al. NIH paper:

A.J. Wilcox, C.R. Weinberg and D.D. Berg, “Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby”, New England Journal of Medicine 333, 1517 – 1521, 1995.

Hodgen et al. paper on different survival times of X and Y sperm:

Q. Van Dyk, M. C. Mahony and G. D. Hodgen, “Differential binding of X- and Y-chromosome-bearing human spermatozoa to zona pellucida in vitro”, Andrologia, Volume 33, Issue 4, Page 199, July 2001.

Johns Hopkins University meta-analysis of six NFP studies:

R. H. Gray, “Natural family planning and sex selection: fact or fiction?”, American  Journal of Obstetrics and Gynecology 1991 Dec; 165(6 Pt 2):1982-4.

University of Washington School of Medicine review and assessment:

P. W. Zarutskie, C. H. Muller, M. Magone and M. R. Soules, “The clinical relevance of sex selection techniques”, Fertility and Sterility 1989 Dec; 52(6):891-905.


Regarding fetal sex preselection

December 2, 2007

Ovulona(TM) and bioZhena Corporation logo

A new friend, interested in the bioZhena technology and venture proposition, has written to me:

“One question that I’ve gotten is around the accuracy of sex selection. I know this is (or can be) a controversial subject. My wife and I (parents of 3 boys) tried using one of the methods in a book to have a girl on our second try. It didn’t work, obviously, and our son decided to come on his own. Could you please tell me more about that part of the test. I understand it in theory but probably it will need to go into clinicals to validate the claim – right?”

I responded fairly promptly, but without details such as the references and especially some graphics, and without expressing serious doubt about my friend’s book and the advice they had drawn from it. This was my response:

Of course, sex preselection is a controversial subject. Most important, though, is that you understand that this is not our initial product offering; it is merely a well justified expectation (speculation), which requires a study and investment, just like the early cervical cancer diagnosis as well as the birth control uses of the Ovulona technology.

What we have for immediate market introduction is the Ovulona as a tool for aiding conception, as previously passed by the FDA, and that did not include any fetal sexing claims.

[NFP = Natural Family Planning; FAM = Fertility Awareness Method]

We will introduce SFP, Scientific Family Planning. SFA, Scientific Fertility Awareness. All four ™-designated.

For your immediate understanding of this particular fetal sexing implications of the bioZhena technology, you presumably are aware of slide 4. Now I summarize for you where this comes from. Namely, I paraphrase from a detailed white paper, which is available for study upon request, if interested:

…a 1992 publication by John T. France et al., reporting data from 55 pregnancies (and births). The study was based on data whereby only one coitus per fertile period occurred, and three different markers were used to estimate the time of ovulation.

The stringency of the study design by France et al. went so far as to exclude 29% of pregnancies from the birth sex ratio evaluation in terms of timing of conception with respect to ovulation, because of more than one act of intercourse during the fertile period. Significantly, the birth sex ratio was 0.50 for this excluded group but far from 0.50 for the good study population.

The results of the France et al. study were as follows: Of the 34 male infants born, 65% were conceived 2 to 5 days before ovulation, and 71% of the born girls were conceived from intercourse timed between 1 day before to 1 day after the estimated time of ovulation. However, there was a great uncertainty about the actual ovulation day because in only 9% of the cases did the three ovulation markers agree with each other. In 68% of the cycles, agreement was within +/-1 day. The peak cervical mucus marker was one while the other two markers were the onset of the LH surge, and the basal body temperature rise.

Hoping that this mildly specialist language is not just mumbo jumbo to you, the key to this is your understanding that until the emergence of our device there has not been a definitive tool for this; that is, not only predicting but also detecting ovulation – and everything else follows from this simple fact.

The France et al. study was the best, better than some others, but even France et al. did not do everything right. For example, John France was not able to share those 9% of cases where the three methods, which they wisely used (to make up for the absence of a definitive tool), coincided in terms of the day of ovulation. Those 9% could have given us a better, almost definitive baseline. (5 definitive cases, if coincidence of three unreliable methods amounts to definitiveness. 5 = 9% of 55.)

K., this slip into details has been due to your scientific education and the personal level of your prior involvement with the subject, which presumably makes for an appreciation not necessarily to be found elsewhere, in other people.

Having quoted the question and answer verbatim, my next post will attempt to improve the answer (the answer to what may well be a burning question in numerous minds) with the illustrations and explanations. That is: Fetal sex preselection – illustrated . Check it out!

References

France et al. paper with data on fetal sex pre-selection, 3-day fertile window:

J.T. France, F.M. Graham, L. Gosling, P. Hair and B.S. Knox, “Characteristics of natural conception cycles occurring in a prospective study of sex preselection: fertility awareness symptoms, hormone levels, sperm survival, and pregnancy outcome”, International Journal of Fertility 37 (4), 224 – 255, 1992.

NIH paper:

A.J. Wilcox, C.R. Weinberg and D.D. Berg, “Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby”, New England Journal of Medicine 333, 1517 – 1521, 1995.

Hodgen et al. paper on different survival times of X and Y sperm:

Q. Van Dyk, M. C. Mahony and G. D. Hodgen, “Differential binding of X- and Y-chromosome-bearing human spermatozoa to zona pellucida in vitro”, Andrologia, Volume 33, Issue 4, Page 199, July 2001


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