Posts Tagged ‘early-pregnancy-loss’

How follicular waves will be used for early detection of pregnancy, and for early detection of miscarriage, EPL – to TTC again asap

August 25, 2010

In this post we talk again about the feature introduced in an earlier post, .

This time we focus on the importance of the utilization of the follicular waves not only for practically instant pregnancy detection, but also for a similarly early detection of miscarriage or early pregnancy loss (EPL, also known as spontaneous abortion, SAB). Refer to Early Pregnancy Loss, . Note: Chief Editor is Professor Lee P. Shulman, MD, FACOG – one of bioZhena Corporation’s Board of Medical Advisors.

Sonography scene. Some contrast vis-à-vis the Ovulona™!

Sonography scene.   Some contrast vis-à-vis the home-use Ovulona™!

Excerpted from said Medscape overview: Early pregnancy loss is unfortunately the most common complication of human gestation, occurring in at least 75% of all women trying to conceive. Most of these losses are unrecognized and occur before or with the next expected menses. Of those that are recognized, 15-20% are spontaneous abortions (SABs) or ectopic pregnancies diagnosed after the pregnancy is clinically recognized.

The incidence of spontaneous miscarriage is 10-15%, whereas the rate of recurrent miscarriage is 3-5%. Approximately 5% of couples trying to conceive have 2 consecutive miscarriages, and approximately 1% of couples have 3 or more consecutive losses.

Early pregnancy loss is defined as the termination of pregnancy before 20 weeks’ gestation or with a fetal weight of below 500 g. An article in summarized the conclusion that “any delay in attempting conception could further decrease the chances of a healthy baby”.

This is a fundamental concept. Further they write, with reference to the original BMJ publication, “Study: Women who conceive within six months of miscarriage reduce risk of another… The women who conceived within six months also had better overall outcomes. They were about 10 percent less likely to have a C-section or a preterm delivery, and about 15 percent less likely to have a baby of low birth weight than the women who waited up to a year.”

This is a highly suggestive conclusion, implying the need to know as soon as possible. The sooner the better for attaining happiness.

Angelo Bronzino - Allegory_of_Happiness, 1564

Angelo Bronzino – Allegory_of_Happiness, 1564

Another fundamental principle, not brought up by CNN or by the study itself, is that a tool for automatic monitoring of the early stage of pregnancy to watch out for EEM [Early Embryonic Mortality] is desirable, to put it mildly. Our Ovulona™ device is perfect for that. The Ovulona monitors folliculogenesis in vivo, which includes the follicular waves occurring after ovulation. The waves disappear upon conception (the pregnant system does not go preparing for another menstrual cycle, which the follicular waves signify).

The follicular waves disappear as soon as conception takes place and the woman is in early stages of pregnancy. In case of miscarriage, the waves will come back. The point made here is that the woman’s and her obgyn’s decisions about trying for pregnancy again should be guided by diagnostic data. The data on which any decision should be based must be personal to the given patient – not based on statistical outcomes of studies such as the one referenced above.

That’s what the Ovulona™ from bioZhena is for, the tested and the putative uses of which are discussed throughout the bioZhena’s Weblog.

For a pictorial overview with a written narrative, you can go to ( ) and peruse the 6 pictures with brief written explanations of the basics of FIV™, the ovulographic™ monitoring of folliculogenesis in vivo™.

This one of the 6 illustrations,, is about “what’s going on here”.  In other words, what is FOLLICULOGENESIS IN VIVO™, the mechanism of the cyclic profiles, the mechanism of menstrual cycles as detected (and passed on to the Ovulona sensor) by the cervix uteri. Should you want to listen to my spoken narrative, click on the image or on the link below.


The unprecedented wealth of information inherent in the FIV™ cyclic profile

The bottom line is this: The multitude of repeatable features of the cyclic pattern makes it possible to determine the boundaries of the fertile window for every individual menstrual cycle.

A key distinction of our technique is that the “dynamic range” of the cyclic profile data (the vertical span) is the same in all cycles and in all women. This – in addition to the repeatable features of the pattern – facilitates electronic interpretation of the data. Only the timing of the various features varies from cycle to cycle, and we work with that.

The cyclic pattern exhibits a number of well-defined peaks and troughs, with the first post-menstruation minimum (or trough, nadir) occurring typically already on cycle day 6, 7 or 8. That’s the selection stage of folliculogenesis (which follows on the stage of recruitment, days 1 – 5). The signal then rises to a maximum (long-term predictive peak, driven by the maturation of the dominant follicle), the highest reading level of the cycle. Over the next several days, the readings fall toward the minimum before the short-term predictive peak. We have found the ovulation-marker minimum after this short-term predictive peak to correlate with urinary LH and FSH peaks (hormones).

Based on data, we interpret the ovulation marker to be an instantly detected effect of the steroid hormone switch that occurs at ovulation (estrogen to progesterone dominance). The follicular waves, which occur after ovulation [when the non-pregnant system prepares for the next menstrual cycle], cannot remain in place after conception takes place [the regime change is even more profound].

That is the principle of instant detection of pregnancy. Should the conceptus be lost to EEM, Early Embryonic Mortality (miscarriage), the follicular waves come back. That’s the principle of early detection of miscarriage also known as spontaneous abortion [SAB], and of detecting and monitoring the return of the non-pregnant condition.

059q Book of hours

059q Book of hours

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

STOP PRESS And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at


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

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.

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. 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 [ ], and check out

Before you go, see this, to get some sense of what is going on here: The link opens a larger version of the slide snapshot image.

Better still, click the next link for the animated and narrated slide:


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; BMJ editorial comment; article “Miscarriage? Try again ASAP, study suggests”; bioZhena’s post “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.


A party with an interest relevant to bioZhena Corporation can be provided with more confidential information upon request (email:

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