The Ovulona™

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

Now a citation:

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

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

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

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

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

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

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

The essence of bioZhena’s primary product offering

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

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

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

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

bioZhena intro in 10 mostly narrated slides https://biozhena.files.wordpress.com/2016/12/new-set-v7-narrated-slides-edec16.pps

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

This blockquote was added in August & edited in December 2016

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

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

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

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

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

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

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

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For further particulars, read on.

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

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

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

That “everything else” also includes the realization that, by interfacing with the cervix, we are monitoring folliculogenesis (the maturation of the egg in the ovarian follicle). And it includes, more importantly, the crucial capability to detect ovulation and not just predicting it.

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

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

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Three baseline cycles from Turin clinical trial

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

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

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

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

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

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

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

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

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


Post script

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

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

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

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

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

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

S… Selection on day  6 ± 1.

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

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

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

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

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

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

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

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

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

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

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

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14 Responses to “The Ovulona™”

  1. Liza Says:

    My fellow on Facebook shared this link with me and I’m not dissapointed at all that I came to your blog.

  2. Variability of menstrual cycles and of ovulation timing « bioZhena’s Weblog Says:

    […] mean the data from a small clinical trial carried out with a prototype of our core technology, the Ovulona™ for home use. This trial was performed by an independent group at Marquette University NFP clinic – with […]

  3. Saint Nicholas Day, a legend about his saving three sisters, and our modern day’s prematurity « bioZhena’s Weblog Says:

    […] idea is that routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation, which is […]

  4. The fallacy of ovulation calculators, calendars and circulating-hormone detectors « bioZhena’s Weblog Says:

    […] unlike our Ovulona™ Smart Sensor™ technology, their method depends on biochemical reagents and since the supply of […]

  5. 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 « bioZhena's Weblog Says:

    […] we were not around with the Ovulona™ to measure the fertile period, and Mrs. Sanger’s zeal took her in the direction of a “magic […]

  6. What is the mechanism of stress and how does it affect reproduction. An update. « bioZhena's Weblog Says:

    […] paper points by implication at the importance of routine Ovulona monitoring of Folliculogenesis In Vivo™ for assisting women who have difficulty to […]

  7. Pharme165 Says:

    Hello! cegeaed interesting cegeaed site! I’m really like it! Very, very cegeaed good!

  8. Fetal sex preselection – illustrated | bioZhena's Weblog Says:

    […] 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 […]

  9. The Ovulona is not another ovulation kit, my dear | bioZhena's Weblog Says:

    […] As stated: The slide indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the […]

  10. Far more than a tool for getting pregnant and for pregnancy avoidance | bioZhena's Weblog Says:

    […] electronic recording of quantified symptoms. Below we show the planned transformation of the Ovulona into a semi-permanently worn cervical ring telemetric […]

  11. M. Abadie Says:

    Your research is good but you are not also looking at the Billings Ovulation Method by Drs. John and Evelyn Billiling. Their research combined with Dr. James Brown and Dr. Erik Odebald. All three of these men and one woman have helped many women worldwide understand their reproductive health, even how to recognize when medical help is needed.

  12. The Ovulona is not another ovulation kit, my dear | bioZhena's Weblog Says:

    […] while generating revenues with the already FDA-cleared minimum-value application of the core OvulonaTM […]

  13. BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN | bioZhena's Weblog Says:

    […] « The Elevator: Swiss VC/PE deal-maker offers bioZhena to their investors The Ovulona™ […]

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