WHY FOLLICULOGENESIS IN VIVO™

In a nutshell:

Uniquely accurate fertility tracking. Detects ovulation. Records women’s 5th vital sign profile signatures for physicians.

Expanding somewhat:

The ovulographic™ cervix-monitoring of folliculogenesis in vivo captures

the fine-tuning neurological effects on folliculogenesis of the direct neural control

via ovarian and uterine innervation.

The Folliculogenesis In Vivo™-monitoring personal home-use smart sensor, the Ovulona™, is unique and superior compared to the many existing commercial products in the category of home-use fertility self-help. That’s including the urinalysis LH hormone kits or OPKs (Ovulation Prediction Kits) and their improved electronic iteration. And including other products such as the currently popular smartphone apps based on the users’ BBT (Basal Body Temperature) aka the Waking Temperature.

The Ovulona is superior on several levels, for a number of reasons.

Unprecedented user-friendly design is made possible by the unprecedented accuracy of  determination of ovulation and of the so-called fertile window, liberating the user from the consequences of the old imperfect-methods-based estimates of ovulation.

That must be the main one for the TTC (Trying-To-Conceive) people, but additional attributes are no less significant. The technique’s broad applicability includes the inherent immediate pregnancy detection and early pregnancy monitoring. The latter is to help manage and deal with the naturally high prevalence of early embryonic mortality (EEM) a.k.a. early pregnancy loss (EPL), spontaneous abortion – the chief complication of human gestation. (See https://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection .)

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

Pregnant

There is more to the superior attributes and applicability of the FIV technology [FIV = Folliculogenesis In Vivo]. Readily thought about is the non-invasive natural birth control.

The Ovulona is an electronic tool for 21st Century’s NFP and/or FAM – that is Natural Family Planning and Fertility Awareness Method. Both of which we envision under the umbrella of Scientific Family Planning™, SFP™ and/or SFA™, Scientific Fertility Assessment™.

Once you become aware of how Folliculogenesis In Vivo works, it will be less of a surprise to learn that the Ovulona tissue biosensor will also provide a built-in, hence eminently affordable and private, cervical health screen – prospectively screening not only for pre-cervical-cancer tissue aberration but also for other sexually transmitted pathologies – and offering a novel approach to the disease treatment.

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

There are numerous other applications that the male managers of investment coffers tend to view as women’s issues, which are not their manly concern. Such as the management of PMS and its debilitating form the PMDD; such as proper evaluation of EDD and EDC (Expected – not Estimated – Date of Delivery, and of Confinement for birthing); such as hormone therapy in peri-menopause, and related matters. All these are big issues of public health, notwithstanding the sentiments of said managers of other people’s money.

Now, back to the primary and initial use of the FIV-via-the-cervix-tracking Ovulona. An overview in three slides: https://biozhena.files.wordpress.com/2018/03/wealth-of-info-elucidation-silent-3-slides-animated-ed.pps. (With more in printable PDF available here.)

Only the Ovulona can determine the three days of the fertile window of opportunity to conceive, unperturbed by the talk out there (by the proponents of the mentioned imperfect ovulation measures) about six fertile days, which talk stems from a certain highly publicized but flawed study in 1995. A NEJM publication caused a sensation at the time by shortening the NFP’s prescribed period of abstinence from the previous much too long imposition to the less off-putting 6 days. See https://v.gd/fCJSGH and grasp this gist of the message: Only the Ovulona-recorded menstrual cyclic profile can tie conceptions to specific cycle days.

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

The determination of the 3-day window is absolutely necessary because only that way can conception be either enabled or avoided with the required accuracy. The existing fertility tracking home-use products cannot do that, and that is why they speak about a longer and fuzzy fertile window.

See relevant posts in bioZhena’s Weblog if you want to get a better understanding of all that which is covered by the short word fuzzy. https://v.gd/9hCBKU is one relevant post. You will get to understand why “peri-ovulation methods” is the fitting descriptor of the prior art methods in https://v.gd/az4Xys.

Neither can the existing commercial products be used for an attempt at baby gender pre-selection by timing conception with respect to ovulation. They cannot do that because they do not anticipate ovulation accurately and they do not detect ovulation – they merely guesstimate and assume its occurrence.

Toyen, Spící (1937)

Toyen, Spící (1937) http://kultura.idnes.cz/podivejte-se-jak-vypada-marne-cekani-od-toyen-ktere-se-drazi-za-20-milionu-1ak-/vytvarneum.aspx?c=A090312_102133_vytvarneum_jaz The title means Sleeping. The referenced source media article’s title says : Look what futile waiting by Toyen looks like… Incidentally, Toyen was a rebel, even more so than Margaret Sanger – or rather, Sanger would next to her probably not qualify for the rebel label… See Description of the image file for more about Toyen: https://biozhena.wordpress.com/2012/05/14/why-too-many-young-and-not-so-young-ladies-could-not-receive-flowers-on-mothers-day-why-so-many-trying-to-conceive-why-so-much-infertility/toyen-spici-1937/ It is not likely that Toyen would have had this in mind, but I present her art to highlight the predicament of unfulfilled yearning for a baby. To highlight this: The probability of becoming pregnant is critically dependent on whether the insemination (natural or artificial) occurs at the right time, within the fertile window. This is because the probability of pregnancy is a combination of four individual probabilities: 1. Probability of being in good health, 2. of successful insemination, 3. of not miscarrying the conceptus, and 4. the probability of correct timing of the conceptive intercourse. For example, a 60% success rate of correct timing brings the overall probability of pregnancy down to a mere 36%, and this goes down to a mere 30% if correct timing probability is only 50%, in healthy fertile couples assuming the probability #3 (not miscarrying the conceptus) at an optimistic 75%. Even if the probability of determining the insemination time correctly were 90%, the resulting probability of successful pregnancy from any one particular insemination event would be only 55%. Get this! Only 55% under perfect ideal conditions, which include a young healthy unstressed woman.

Consequently, those technologies cannot pinpoint the 2 days before and the day of ovulation. This detection of the 3 days is needed for trying to conceive a boy or for trying to conceive a girl, when trying to get pregnant. For more see https://v.gd/3xndsX.

And the ability is needed for avoiding conception, i.e. for avoiding pregnancy. The commercially available technologies do not detect ovulation independently of the one predictive element that they test for; or two such elements, LH and E2, in the case of the urine-analyzing gadget sold by the mighty P&G in joint venture with SPD GmbH. But for the user relying on that is not unlike groping in the dark…

Of the other electronic gadgets out there, the one offered by Zetek, is tracking indirectly the effect of the same hormone (estrogen) in two body fluids with two probes at two different times during the menstrual cycle.

And then there is your old BBT method – implemented by several costly products and utilized by many smartphone apps. The BBT tracks indirectly the effect of progesterone that you know causes the BBT to go up a bit after ovulation, albeit with a statistical uncertainty of + or – 3 days, and a poor signal to noise ratio and interference from responding to non-related things at that. (See single narrated slide overview of competition at https://v.gd/b696FF.)

All those old *Imperfect Measures* tools detect a hormone input (or two) within the hormone signaling mechanism. However, the boundaries of the fertile window are not single hormone events. Circulating hormone monitoring – direct or indirect – cannot define the fertile window. The existing ovulation prediction products do not determine the fertile window of 3 days because they monitor this or that remote parameter that only reflects some pre-ovulation  aspect of folliculogenesis, the process that culminates in ovulation.

The *Imperfect Measures* products only detect one of the hormone signals that says “ovulation can happen about now” (LH), or a signal that says “ovulation has occurred” (BBT); or some reflect estrogen (e.g., through the appearance of saliva). Estrogen elevates before LH but not far enough ahead, and certainly it does not indicate the beginning of the fertile window nor the end of the window (ovulation). The saliva property is a fuzzy indicator of estrogen, and similarly the vaginal fluid’s tactile and visual properties tracked by some NFP users. But accurate undistorted *perfect measure* of fertility must monitor the brain-ovary feedback. See: https://v.gd/j6nAoD.

Clock Explosion by Salvador Dali

Clock Explosion by Salvador Dali

Significantly, the hormones that anticipate ovulation do not mean that ovulation occurs as estimated or even at all. The hormones merely signal that the reproductive system is ready.

It is essential to detect the actual occurrence of ovulation independently of its prediction. Only our technology does that. Only our technology anticipates ovulation quantitatively in daily reference to the menstrual cycle FIV profile, and then detects ovulation separately from and independently of the predictive data.

Stress often delays or even prevents ovulation – a surprisingly frequent occurrence (https://v.gd/QLjHD6). Only the Ovulona™ detects and works with this: https://v.gd/1jCnuO and  https://v.gd/z4xCIJ.

There are bioZhena’s Weblog posts about the variability of ovulation timing from cycle to cycle in the same woman as well as across a population. The variability can be more than the width of the fertile window, more than the said 3 days. That 3 day span tends to also be the statistical uncertainty of some of the old techniques, plus or minus 3 days. This is serious because every day matters, every day makes a difference.

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

Ovulona prototype detects delayed ovulation click to enlarge

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

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

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

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

In an earlier post in this blog, I showed how the test data divides the NFP clinic patients’ results into two categories that we termed regular and irregular (challenged). To avoid confusion with the traditional usage of the term regular/irregular in the context of menstrual cycles, we shall refer to the two categories as ordinary and challenged, respectively. Cycle 2 above is an ordinary cycle (with LH and Peak mucus within 1 day of ovulation marker day) versus the other records showing challenged cycles with delayed ovulation. (See blog post at https://v.gd/Va6GMQ.)

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

Challenged menstrual cycles in 10 womenclick to enlarge

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

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

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

The Smart Ovulona™ will display for the user the interpreted result such as either NOT FERTILE or, as detected, FERTILE DAY 1, FERTILE DAY 2, or fertile day 3 = OVULATION. When appropriate, the display will indicate PREGNANCY! or SEE DOCTOR ABOUT CERVIX (the latter when a cervical tissue aberration will be detected in several consecutive cycles – to avoid and liberate women from the known anxiety-causing problems of the Pap smear test).

We can and we do envisage the Ovulona use (and later the telemetric HaloTM cervical ring) to become a friendly routine for the women of the 21st century, everywhere. The existing home-use fertility monitoring products could not aspire to play that role. Hormone detection in body fluids is only of temporary utility for the TTC women.

Against that, Folliculogenesis In Vivo is not only a superior tool for TTC but it goes beyond that first use – to be of unprecedented and unique service in personalized women’s healthcare for years to come. View 3 slides (Ovulona from startup version to cervical ring implementation): https://v.gd/paNdRr. And see how the bioZhena technology will help physicians to better help their female patients (explore the links): https://biozhena.files.wordpress.com/2019/01/Single-slide-How-the-Ovulona-will-help-physicians.pdf.

Refer to relevant posts in bioZhena’s Weblog (here is clickable table of contents with snippets) and other articles about how symptoms (such as PMS symptoms) vary depending on the phase of the menstrual cycle and on the health conditions of any woman. It is known that female patients respond to therapy differently in relation to their menstrual cycle, i.e., in relation to folliculogenesis. That relationship to the FIV profile is THE fundamental guiding principle of personalized medicine for women.

A new era of gynecology and obstetrics in the offing.

FIV for women's healthcare - the vision (from Space perspective)

Folliculogenesis in vivoTM for women’s healthcare – the vision (from Space perspective, courtesy of NASA)

Yes, dear reader, contingent upon securing capital, both financial and human…   Durer - Witches - 5%

 

 

 

 


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