Archive for the ‘medical-device’ Category

bioZhena venture

July 9, 2015

Transforming Female Reproductive Health Management prt scr

Explore the few slides including the links in some of them: https://biozhena.files.wordpress.com/2017/03/new-mostly-narrated-slides-2017-03e2.pps

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Perhaps – especially if you are a male reader – you may feel that a daily (or almost daily) insertion for the quick self-check is too much to expect of a woman keen on knowing her daily fertility status plus the additional benefits of the routine?

Then our next generation telemetric cervical ring iteration of the same smart sensor is the answer for you. She and her doctor will have a choice.

See the image of a slide and click it to view the slide:

Friendly Technology - with cervical ring & Ovulograph

https://biozhena.files.wordpress.com/2017/05/single-slide-friendly-tech-with-cervical-ring-ovulograph.pps

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And here is now the financial pro forma aspect of bioZhena’s breakthrough non-interventional approach to women’s healthcare.

5-year pro forma assuming $6M funding (Business Plan Summary Financial Projections)

Or

10-year projections:

Minimum Viable Product Scenario (MVS) and Full Value Scenario (FVS)

FVS compared with MVS

https://biozhena.files.wordpress.com/2016/09/comparison-mvs-cf-fvs.pps

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bioZhena’s pitch on EquityNet:

Women’s personal sex management for the Information Age.

Generating diagnostic vital-sign profiles for doctors and payers. This first app of proprietary cervical sensor has FDA clearance.

Income from it will support further breakthrough applications.

The gist of the bioZhena women’s healthcare breakthrough is this:

We monitor the brain – sex organs feedback loop.

Nobody else does.

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See the illustration below. Grasp the significance: The market offers you anything other than what’s needed, which is the monitoring of the feedback brain – ovary interactions.

“To mitigate the startup investment risk, the first app is an already FDA-cleared electronic fertility monitor for women at home…

Our electronic technology platform is bound to revolutionize women’s healthcare with diagnostic tools for women and their doctors & payers.

… will provide for non-interventional reproductive management, aiding conception and natural birth control without hormones, and automatically detecting pregnancy – planned or accidental. …

We will offer early detection of cervical cancer and other STDs as a built-in screen performed innocuously in the privacy of one’s home – automatically in the background of the primary monitoring…

Ovulona™ tracks the female reproductive cycle via the end-organ effect of the brain-ovary feedback loop on the uterine cervix. Numerous benefits ensue…”

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For a fuller description of the project, go to https://www.equitynet.com/c/biozhena-corporation

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HPG slide 4 screen shot from 5 slide show

This is a screen shot of slide 4 from a 5-slide set https://lnkd.in/ed9yXUX

– one of the materials provided in the EquityNet posting.

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Contra Nescience Contra Insouciance (SM 2015)

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And yours truly bioZhena founder seeks a well-matched management partner of either gender.

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Cervix uteri and seven or eight related things

February 7, 2012

It seems worthwhile to reblog the December 2007 post about the basics. Including “why the bioZhena technology had to be invented. One way of saying this is: The available means, methods or products, were not good enough. Another way of putting this is to quote from medical literature…”

And then see how none of the methods determined ovulation with the required accuracy to be useful either as a conception aid or especially for birth control.

3-day fertile window with gender preselection vs. inaccurate old methods

3-day fertile window with gender preselection vs. inaccurate old methods

Here is how our method (monitoring folliculogenesis in vivo) does it by generating the multi-featured cyclic profile that includes the definitive ovulation marker after the predictive signals, and here is how this compares with the older techniques. See how inaccurate is the ovulation assessment by the older means available to the users of NFP or FAM.

For more about the data in the above illustration, go see another old bioZhena post, “Regarding fetal sex preselection”, at https://biozhena.wordpress.com/2007/12/02/regarding-fetal-sex-preselection/ .

bioZhena's Weblog

For these and other terms, see the Alphabet of bioZhena at /2007/11/28/the-alphabet-of-biozhena/

Rerum Naturare Feminina. A Woman’s Natural Thing. In the lingua franca of the ancients.

The reader of this bioZhena’s Weblog article will or should be well aware that a woman’s menstrual cycle lengths are quite variable, as is the timing of her ovulation within those menstrual cycles. For evidence of this variability, see another blog post at https://biozhena.wordpress.com/2010/03/07/variability-of-menstrual-cycles-and-of-ovulation-timing/ (opens in new tab/window). Our focus on the cervix uteri is clarified below in this article.

Cervix:

The narrow lower part of the uterus (womb), with an opening that connects the uterus to the vagina. It contains special glands called the crypts that produce mucus, which helps to keep bacteria (and other microbes, including sperm for most of the cycle) out of the uterus and beyond. Sometimes called the neck of the womb, it protrudes into the vagina. The region…

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Much in women’s health revolves around folliculogenesis – from teen age to peri-menopause

November 30, 2011

In this article I sketch for you the usefulness of the Ovulona™ Smart Sensor™ throughout a woman’s life, with particular attention paid to the extremes of the reproductive lifespan.

We outline the significance of the cervical tissue biosensor for a woman’s health management from adolescence (the teen years) to peri-menopause. This schematic diagram is a pictorial synopsis of the multi-purpose utility of the Ovulona throughout most of a woman’s lifetime.

Ovulona throughout a woman's life

As you recall from prior posts on this blog, FIV™ stands for FOLLICULOGENESIS IN VIVO™, which translates as the sequence of menstrual cyclic records that will be captured and stored (automatically saved) in the Ovulona during normal use by a woman at home. The data is available for transfer to healthcare providers’ Ovulograph™ for medical uses during the reproductive years.

The reproductive age is officially defined as 14 to 44 but we’d encourage, for health reasons, to chop off a few years at both ends from the actual reproductive (high end) or sex-exploration activities (low end). When folliculogenesis – i.e. menstrual cycling – ceases in menopause, hormone therapy and cervical tissue health screening are the two components of menopause and post-menopause health management, to which the Ovulona is applicable.

In this article, I address very briefly (tweetingly!) the two “boundary conditions” of said reproductive years.

I’ll deal with the young boundary condition, i.e. adolescence or teen age, in the style popular nowadays especially at that stage of life . That is, I let speak a few tweets, mostly from http://topsy.com/biozhena.wordpress.com/2009/03/12/far-more-than-a-tool-for-reproductive-management/ .

When you look at the tweetingly referenced papers (click the short URLs below), you will see how the teen cramp sufferer needs our Ovulona. That’s because she must take the anti-inflammatory medication before the ovulation-linked pain hits, otherwise the med would not work. She – or is it you? – must be able to anticipate ovulation. You need the Ovulona. The timing is crucial, similar to the right timing for conception purposes… (Recommended reading: http://endometriosis.org/treatments/painkillers/ = http://to.ly/6ZsS in the #NSAIDs tweet below).

If it’s menstrual bleeding (not ovulation) that pains you, the Ovulona will tell you when you expect that – whether it is ovulation + 14 days or, probably more likely at this young age, ovulation + irregular. You’ll then see on the display your recorded min and max, with respective probabilities the more accurate the longer you’ve used the Ovulona. That’s this app’s meaning of Smart Sensor™ for you! (And that is because we don’t track just this or that hormone in your pee! Or your BBT, or your signs…)

As for the STD screening aspect of those young years, indicated in the pictorial synopsis above, I refer you to the recent posts in this blog; and the sex ed use of the Ovulona – or rather its recorded data and their discussions in classes – is self-explanatory.

But then there is the subject of chemical contraception, the Pill. So, here, a couple of tweets from http://topsy.com/biozhena.wordpress.com/2010/06/27/about-atrophy-reproductive-aging-and-how-it’s-really-not-nice-to-fool-mother-nature–or-with/?utm_source=topsy_module

A teenage girl has a #dilemma With the #Pill she brings on herself a significantly earlier #menopause & likely difficulty to #conceive when desired http://to.ly/5f2W

#Menstrual #cramps are bad but don’t allow them – by taking the #Pill – to cause you the much worse #pain of TTC #infertility http://to.ly/5f2W    [TTC = Trying To Conceive. That’s the phrase and acronym used by people who have difficulty getting pregnant.]

http://to.ly/5f2W Even with just 3-15 months of #contraceptive #pill use you suffer greater loss of S crypt cells than can be replaced. Then hard TTC is likely   [S crypts are part of the microscopic structure of the cervical epithelium, of the tissues.]

Here now are those few tweets referring to dysmenorrhea, the menstrual pain which causes so much suffering and so many lost hours at school and/or at work. In this day and age!

#NSAIDs against #endometriosis pain http://to.ly/6ZsS Since you must take the meds BEFORE expected #cramps you need our Ovulona tool to anticipate ovulation http://to.ly/MJS [NSAIDs = Non-Steroidal Anti-Inflammatory Drugs]

@bioZhena/fertility    http://to.ly/MJS Why most girls get cramps What goes on there Why & what’s PCOS See it with Ovulona [Obese girls tend to grow into women with PCOS = Poly Cystic Ovary Syndrome, the cause of major killer diseases, and often causing infertility.]

Folliculogenesis #InVivo for Why Do Most Girls Suffer With #dysmenorrhea #cramps http://to.ly/MJS #womenshealth #diagnostic #medicaldevice

Ovulona for etiology & management of  #dysmenorrhea Why do teen girls suffer with #crampshttp://to.ly/MJS #pharma #medtech #medicaldevice [etiology = the cause or origin of a disease]

Re: etiology of adolescent #dysmenorrhea Prostaglandin theory & treatment known since the 1980s Why are period cramps still so bad?

I leave you and this “boundary condition for Ovulona’s use” with two Google Insights graphs. Look here how the worldwide interest level in the subject of period cramps has been increasing since 2004.

Period cramps worldwide searches from 2004 by Google Insights

Period cramps worldwide searches from 2004 by Google Insights

Don’t ask me why the recorded public interest is emanating from those particular English-speaking countries and not from numerous others, and look for details at http://www.google.com/insights/search/#cat=0-45&q=period%20cramps&cmpt=q (you can change the selected parameters and observe the effect of the changes).

I merely note the periodicity developing in the data in recent years on top of the clear upward trend, the periodicity indicative of highest interest in summertime (such as in July 2011)…

This is, of course, the same in the next graph, where I added dysmenorrhea (red) for comparison. That’s a difficult word, so it is not as much searched on as the colloquial cramps – except for, if you look closely, in (Southeast)Asia.

Period cramps & dysmenorrhea worldwide searches since 2004 by Google Insights

I’ll now use one more tweet to segue into the other end of the span of reproductive years.

#estrogen can be a good medication but we need #personalizedmedicine tools We must measure & titrate #hormone uptake http://t.co/CeCsWgn

The following illustration shows that we at bioZhena have the technology with which to do that, i.e. a tool with which to adjust treatment to suit a given female patient.

The illustration is a graph of the effects of estrogen and progesterone monitored with our technology in an ovariectomized pig. Ovariectomy is the removal of the ovaries. It is the animal equivalent of surgical hysterectomy, which causes surgical menopause since the reproductive system no longer produces said sex hormones, the sex steroids estrogen and progesterone.

In the illustrated experiment, the steroids were later given to the animal (after recovery from surgery), and the result was that progesterone drove the sensor signal down versus estrogen drove it up (as seen in FIG. 5 below, excerpted from our patent portfolio). This is a useful finding, for example for monitoring the effects of hormone replacement therapy (HRT). 

Graph of estrogen and progestagen effects on porcine cervix

Graph of estrogen and progestagen effects on porcine cervix

We also have the proof of the concept generated by a menopausal woman, using a Premarin treatment in that experiment (Premarin is an estrogen medication used for treating the symptoms of menopause including hot flashes, vaginal dryness, etc.). The data was used in another patent in our portfolio.

Background on menopause, HRT and bioZhena can be found in the early blog post at https://biozhena.wordpress.com/2007/12/18/menopause-hrt-and-biozhena/ .

Experts advocate that women in their 30s and 40s should look at menopause now. Health maintenance depends on diagnostic tools. We propose that the preparation for menopause be done – in a simple quick daily routine – by systematically monitoring the Ovulona menstrual cyclic profile, and how it changes over the years. How it responds to pregnancy and birth, to things like diet, exercise, various ills, various medications, stress… in the particular woman user, not some statistical average. For evidence-based personalized health care.

That’s the broader meaning and the purpose of the folliculogenesis cyclic profile generated by the Ovulona. It’s not merely (“merely”!) for helping to get pregnant or for avoiding pregnancy without chemicals, as is illustrated and described in “Pregnancy and birth control how-to by bioZhena” at this Photobucket site. In the third graphic, on this page, see the follicular waves that relate to follicular age, i.e. how fast is menopause approaching, after pregnancies were successfully achieved and then regulated in this Ovulona-guided manner.

This is because the cervix monitors the physiological inputs after conception and after pregnancy just like it does the monitoring before fertilization and before birth. We pick up the diagnostically useful information from this key female organ. We speak of end organ effects.

For a still broader perspective, including symptometric monitoring correlated with folliculogenesis, go to “Far more than a tool for reproductive management”.

STOP PRESS

And after all that, 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/

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?

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. See  http://s755.photobucket.com/user/vaclavkirsner/library/Second%20album/Pregnancy%20and%20birth%20control%20how-to%20by%20bioZhena?sort=2&page=1 = a pictorial “Pregnancy and birth control how-to by bioZhena”.

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’s 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. Should you be new to this, https://biozhena.wordpress.com/about/ is an introduction.

Automatic pregnancy detection is inherent  in the Folliculogenesis In Vivo™ cyclic profile

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”, and you can 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 patient, that is, 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.

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, https://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection .

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,  http://emedicine.medscape.com/article/260495-overview . 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 http://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ 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 http://to.ly/VCF (http://s755.photobucket.com/user/vaclavkirsner/library/Second%20album/Pregnancy%20and%20birth%20control%20how-to%20by%20bioZhena?sort=2&page=1 ) 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, http://to.ly/1k9L, 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.

wealth-of-information-inherent-in-cyclic-profile-signature

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

https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps

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 https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

About atrophy, reproductive aging, and how it’s really not nice to fool Mother Nature – or with

June 27, 2010

I have taken it upon myself to popularize Prof. Erik Odeblad’s classic findings about the biophysics of the tissues and secretions of cervix uteri, and how they translate into reproductive physiology and hence to reproductive medicine – at home and in the doctor’s office.

Emeritus Professsor Erik Odeblad

  Emeritus Professor Erik Odeblad    “The cervix is a precision organ as complex as the eye”

My ulterior motive is that I want to be understood when harking back to the British commercial’s exclamation that warned about too arrogant an attitude towards Mother Nature. Or, maybe I aim at the wisdom of the saying (“It’s not nice to fool Mother Nature!”) to be appreciated particularly within the given field of endeavor and/or endeavour – that is, reproductive management. Even if it were only in a segment of it.

In the Alphabet of bioZhena (which is no Alphabet of Ben Sira, though we model on it somewhat), https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf , there is an entry about Atrophy and what it does to a woman as years go by, how “atrophy of mucosal surfaces takes place, accompanied by several problems.”

Jan Amos Komenský (Comenius) Says Farewell to...

Jan Amos Komenský (Comenius) Says Farewell to…

In this blog post I focus on aging – and thus atrophy – of the cervix, leaving aside the inevitable corresponding phenomena in other parts of the reproductive system.

The focus on the cervix is due to bioZhena’s focus on the cervix… which in our scheme of things is the supreme monitor of the complex reproductive goings on that Mother Nature designed in order to cope with all that complexity. After you’ve read the Alphabet article on atrophy, you might scroll down to the entry there about the cervix, which will take you also through cervical cancer and cervical mucus, besides a couple of other things cervical. That will or would be a nice preparation for, or introduction to, what follows.

Prof. Erik Odeblad's sketches from www.woombeuskadi.org...4_erik_odeblad(secrecion_cervix).pdf 13 February 2008

Two sketches by Emeritus Professor Erik Odeblad to illustrate his saying, “The cervix is a precision organ as complex as the eye”. Click (right-click) on the image to see the details. And read on about the details. The fine structure of the cervical canal wall, schematized on the right, is based on examination of mucus samples obtained with a suction syringe from the various parts of the cervical canal of human volunteers for physico-chemical examination.

When, at the inception of the project, we decided to focus on the given part of the anatomy, Erik Odeblad’s work logically and inevitably became a part of the background. He used the NMR (nuclear magnetic resonance) technique of physical chemistry to perform the complicated investigation of cervical mucus, and he produced the classical evidence for the difference between the “fertile” mucus macromolecules that allow the passage of the sperm, and the “infertile” cross-linked glycoprotein molecular network that does not. (To this day I remember his usage of “undulations”…)

In fact, this early information, which involved the thiol-disulfide (sulphydryl-disulphide) redox couples in the glycoprotein macromolecule, had much to do with our early hypothesis of the mechanism of our measurements. Never mind that his work was in the context of the subjective self-examination used in NFP, which did not work for the female member of the team! Had it worked for her, there would probably not be any Ovulona™ for monitoring folliculogenesis in vivo (FIV™ – which has utility well beyond fertility status determination)!

With atrophy being the general biological aspect of aging (and with the initially very large number of ova or eggs in the young female’s ovaries decreasing as she matures and ages), the cervix similarly “undergoes a natural process of development and aging. The surface area of the cervix that is given over to the mucus secreting glands [“crypts”] gradually diminishes with age.”

Odeblad defines three types of the (endo)cervical glands, which he (and others too e.g. Embryology.CH and Eurocytology.EU since at least the 1970s) calls the “crypts”:

  • S crypts produce S mucus, which forms string-like channels and provides transport (“swimming lanes”) for sperm cells. (“Produces a wet, lubricative sensation at the vulva.” That’s for the NFP sympto-thermal method use, the Billings method and/or the Creighton Model NaProEducation Technology method, the classical NFP or FAM – the latter, Fertility Awareness Method, publicized by Ms. Toni Weschler’s 2002 book Taking Charge of Your Fertility .)
  • L crypts produce L mucus, which eliminates low-quality sperm and provides a structure to support what he calls the S and the P mucus. P is a reference to the so-called Peak mucus of NFP or FAM.
  • G crypts produce G mucus, which is “an impenetrable gestagenic mucus formed in the lowest cervical crypts. Prevents sperm entry to the cervix and is part of the immune system which protects the woman’s reproductive system from infection.” A remark from dictionary.com: gestagen (jěs’tə-jən, -jěn’) n. A substance, such as a steroid hormone, that affects the uterus in a manner similar to progesterone. And a remark from a scientific commentator: This G mucus is characterized by the oxidized state of the mentioned redox couples, causing cross-linking in the glycoprotein mucin, which prevents microbes including sperm from entering. Visualize this as closed -S—S- gates (as opposed to the open gate form -SH   HS- of the “reduced” state of the redox couples; “reduced” meaning “electronated and hydrogenated”, the opposite of “oxidized”).
Mondrian_Evolution

Mondrian_Evolution

There are three fundamental principles at work.

1. Natural baseline aging, and this is fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts, at somewhat different rates: S the fastest, L somewhat slower, G slower still.

2. Slow-down of the aging atrophy by pregnancy.

3. Acceleration of the aging atrophy by the Pill [and/or by other endocrine-active compounds, EACs – this is a logical extrapolation, speculative, but must be assumed].

Now, then.

1. Natural baseline aging, fundamental – a more or less linear decrease in the number of all three kinds of these glands or crypts:

“The number of S crypts decreases from teen age. They are first replaced by L crypts starting at the base of the cervix. Later G crypts replace the L crypts.”

Thus, from Odeblad’s graph [rate reckoned from 15 yrs old to 40 yrs old]:

S crypt baseline decrease or diminution (or atrophy) rate:

50% / 25 years = 2% per year.

At 50 years old, S crypts are at some 10%.

Profile crypts baseline never pregnant never on the Pill

Profile of cervical crypts of a baseline woman – never pregnant & never on the Pill

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy or use of the Pill.

This is a baseline profile.

Here is Erik Odeblad’s schematic of the crypts on the surface of the cervical canal:

Cervix of a 20 year old virgin

Carefully mapped lateral wall of the cervix of a 20 year old virgin           (reported by Emeritus Professor Erik Odeblad, Department of Medical Biophysics, University of Umeå, S-90187, Umeå, Sweden)

This is Professor Odeblad’s artist’s impression of cervical mucus secretions:

Mucus secretions

Schematics of cervical mucus secretions

Key to colors:

Blue         = S mucus

Yellow     = L mucus

Red          = G mucus

Green      = P mucus of which there are several sub-types

Pink         = Z granules

Professor Odeblad’s explanatory notes:

Z granules – the enzyme in the Z granules combines with the P mucus to create a liquefying effect.

P mucus – there are a number of sub-types of this mucus, the most relevant for fertility are P2 and P6. P2 could be present as early as the beginning of the fertile phase possibly having a role in liquefying the G mucus. P6 is mostly confined to the upper part of the cervix, occurring close to the Peak of fertility, and having a role in conveying sperm. It creates a very wet and lubricative sensation at the vulva.

F mucus – comes from the cells scattered throughout the length of the cervical canal and has no known special function.

For a recent evidence of four different morphological mucus types, namely L, S, P and G, see “Morphological characterization of different human cervical mucus types using light and scanning electron microscopy” by M. Menárguez, L.M. Pastor and E. Odeblad, Human Reproduction, Vol. 18, No. 9, 1782-1789, September 2003 –  http://humrep.oxfordjournals.org/cgi/content/full/18/9/1782

Citation: “The distribution of crypt zones in the cervix depends on age, number of pregnancies and use of contraception. In a non-pregnant woman, aged 25–30years and not having used contraception, the cervix averages 22 mm in length and 6 mm in diameter at ovulation. The crypt distribution starting from below and moving upwards is as follows: the G crypts dominate in the lowest 4–5 mm; then there is a zone of L crypts occupying the next 9–10 mm; this is followed by the S zone, for 5–6 mm; and the highest 3–4 mm contains the P crypts.”

When you read the paper, you detect that he has a very special knack for sampling the respective mucus types from the said crypts. Hat off! Work with human experimental subjects is no stroll in the park, to put this mildly.

2. Slow-down of atrophy aging by pregnancy:

Profile crypts 4x pregnant

Profile of cervical crypts of a 4x pregnant woman

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life with four pregnancies and no use of the Pill.

Pregnancy – S crypt diminution rate from Odeblad’s graph

[4 pregnancies, no Pill, rate reckoned from 15 yrs old to 40 yrs old]:

30% / 25 years = 1.2% per year.

At 50 years old, S crypts are at some 20%.

3. Acceleration of atrophy aging by the Pill [and/or by other endocrine-active compounds, EACs – a logical extrapolation]

Profile of cervical crypts of a woman on the Pill

Representative profile of cervical crypts

(percentage of cervix occupied by active crypts)

for a woman who goes through life without pregnancy and uses the Pill for 10 years

Pill – S crypt diminution rate from Odeblad’s graph

[no pregnancy, Pill for 10 years (18 to 28 yrs old), rate reckoned from 15 yrs old to 40 yrs old]:

60% / 25 years = 2.4% per year.

At 50 years old, S crypts are at some 5%.

This includes the slow down of the diminution gradient during the last 12 years of no Pill.

Compare this with diminution/atrophy rate during the 10 years on the Pill:

65% – 25% = 40% / 10 years = 4% per year.

This is double the baseline rate of cervical atrophy.

It’s more than 3 times higher than the pregnancy-slowed atrophy rate.

Three concluding remarks by Prof. Odeblad:

“Regression when taking the Pill is different for estrogen-dependent crypts (L and S) and progesterone-dependent crypts (G) which may in part overdevelop.”

“The study of the effects of contraceptive pills on the cervix is a difficult task. A considerable amount of work is required for each patient and the time required spans many years, up to 10 years or more. Many women also want to change to other pills or to other methods of contraception, or perhaps now want to become pregnant. It also happens that some pills are withdrawn from the market. To these difficulties are added the normal age changes in the cervix and the dynamic processes which are of constant occurrence. After 3 and up to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced.” (“Some Notes on the Cervical Crypts”, Dr E. Odeblad, Bulletin of the Ovulation Method Research and Reference Centre of Australia, Vol 24 No 2 June 1997, p31)

Citations and graphics reproduced from http://www.billings-ovulation-method.org.au/act/cervix/ageing.shtml .

“Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural oestrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced. Treatment is difficult.” He also wrote: “After 3 to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced … A pregnancy rejuvenates the cervix by 2-3 years, but for each year the Pill is taken, the cervix ages by an extra year.” Web reference:  http://www.billings-ovulation-method.org.au/act/pill.html .

Comment on implications for treatments of certain symptoms

For example, the suggested method [Weschler, Toni (2002). Taking Charge of Your Fertility (Revised ed.). New York: HarperCollins. p. 52] of thinning cervical mucus to help achieve pregnancy by taking the OTC expectorant drug guaifenesin, which is thought to act by increasing the volume and reducing the viscosity of secretions.

The drug is also used to treat the symptoms of primary dysmenorrhea [severe uterine pain during menstruation ] where another treatment of choice is combined oral contraceptives [COCs]. Such treatments are administered to adolescents as well as to mature women because dysmenorrhea is a very common and serious problem (25% of women and up to 90% of adolescents ).

In both cases, the expectorant and the contraceptives are administered without knowledge of their mechanism of action in the given problem. Focus is on treating symptoms, not the underlying causes. The patient is the detector of any effect. How does the expectorant drug use correlate with the secretions of the different types of cervical mucus on the one hand, and with the folliculogenesis cyclic profile on the other? Is there any connection? If not, what does the drug do to the different crypts? And what the COCs do to them?

Is the expectorant so selective that it might do the right thing? Reduce type G? Enhance type S mucus? Does oxidation of the guaifenesin help reduce the cross-linked mucin type G in the cervical canal? As simple and pretty as that? (Even prettier if guaifenesin were not to be an EAC, an endocrine-active compound … which inactivity does not look likely – http://www.who.int/ipcs/publications/en/ch3.pdf .)

Would it not be nice to have a rationale for how the small guaifenesin molecule can have a good effect on both sub-fertility/infertility and dysmenorrhea?

Could it be that guaifenesin works bioelectrochemically in the same oxidation-reduction (redox) manner on the enzyme cyclooxygenase in the prostaglandin cascade, which is a cascade of redox reactions – producing an anti-inflammatory effect that translates as suppression of pain? (On a personal note, why not capitalize here at least conceptually on our ancient Wellcome Research Labs work, even before receiving – presumably – the first pension money from Glaxo Smith Kline?)

It’s easier to contemplate in general the effect of the contraceptive drug, which will presumably depend on the contents of the estrogenic and gestagenic components (modeling on Odeblad’s findings)…

Is there a connection between pain, cervix and ovaries, ovarian reserves? Maybe an abnormal depletion of, via ovarian cysts? Will the number of follicular waves and/or other features in the Ovulona cyclic profile – and correlated with ultrasound and MRI – show any such abnormality? Might the Ovulona be useful for diagnosis here, convenient, simple (inexpensive)? Wouldn’t that be nice?

Is cyclooxygenase inhibition detected by the cervix, does it show in the cyclic profile? Does said prostaglandin synthesis inhibition alter the number of follicular waves – while reducing the pain?

Answers to questions like these are needed. Keep in mind that ovulation is an inflammatory process, and since we detect it in the cyclic profile, it is reasonable to pose the above prostaglandin theory questions about the COX-2 (cyclooxygenase) inhibition.

Summarizing Odeblad’s results and the take-home message:

Baseline outcome of cervical S crypts aging: S crypts down to 20% at 40 years of age. Here you have the reason why mature age leads to sub-fertility and to infertility.

Atrophy slow-down effect of 4 pregnancies: S crypts down to 40% at 40 years of age. Here you see Mother Nature’s design in action. Pregnancy slows down the inherent rate of cervical aging (atrophy, deterioration). Naturally, this is not to argue for 4 pregnancies per lifetime – it’s merely how the effect was made measurable.

Atrophy acceleration effect of 10 years on the Pill: S crypts down to 10% at 40 years of age. Here is why it’s not nice to fool Mother Nature, why it’s not good to mess with her design. The Pill is an archetypal anthropogenic Endocrine-Active Compound [man-made EAC], and it was brought up in the previous post how there are very many of these EACs, all insulting the female body and health, some – like chemical contraceptives – by design.

While the story of Laodamia and Protesilao is touching, I merely want to ask that girls, ladies and their physicians do not moon the messenger.

Laodamia

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/

Folliculogenesis in vivo™ monitoring is far better than current home-use fertility self-help tools

March 28, 2010

And here is again why

The FIV™-monitoring Ovulona™ is superior compared to existing commercial products in the home-use fertility self-help category, such as the urinalysis hormone (LH) kits or OPKs and their improved electronic iteration, and other such products. Superior on several levels.

Unprecedented user-friendly design coupled with unprecedented accuracy, liberating the user from the vagaries of imperfect ovulation method-based probabilities.

That must be the main one for the TTC [Trying To Conceive] people, but additional attributes are no less significant. Multi-purpose applicability including but not limited to built-in early pregnancy detection and early pregnancy monitoring. That’s to help manage and deal with the inherently high prevalence of early embryonic mortality [EEM], 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. Just think about this for a moment. The EEM is Mother Nature’s design to deal with problems that quite likely lead to the TTC challenge (aka sub-fertility or even infertility) in the first place…

Pregnant

There is more to the superior attributes of the FIV technology [FIV = Folliculogenesis In Vivo]. Readily thought about is non-invasive natural birth control. The Ovulona is an electronic tool for 21st Century’s NFP and/or FAM. Natural Family Planning and Fertility Awareness Method, both of which we envision under the umbrella of Scientific Family Planning™, SFP™.

Furthermore, once you become aware of how Folliculogenesis In Vivo works, it will be less of a surprise to see that the Ovulona tissue biosensor will also provide a nice and easy cervical cancer screen – and prospectively screening for other pathologies, and their treatment…

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

Of course, there are still other applications that the male managers of investment coffers tend to view as women’s issues that are not their concern, such as management of PMS and its debilitating form the PMDD, such as proper evaluation of EDD and EDC (Expected Date of Delivery, and of Confinement), such as hormone therapy and related matters. All these are big issues of public health, the sentiments of said managers of other people’s money notwithstanding.

Book of hours - 069q

Now, back to the primary and initial use of the FIV-tracking Ovulona.

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 imperfect ovulation measures – about six days, which talk stems from a certain highly publicized and yet flawed study in 1995… A publication (in NEJM) that caused a sensation at the time by shortening the NFP’s prescribed period of abstinence from the previous too long imposition to the less off-putting 6 days).

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

The determination of the three days window is absolutely necessary because only that way can conception be either assisted or avoided with the required accuracy. The existing home-use fertility tracking commercial products cannot do that, and that is why they speak about a longer and fuzzy fertile window. See preceding and older posts in this blog if you want to get a better understanding of all that which is covered by the short word fuzzy. You will also get the long word (peri-ovulation methods) if you delve into the matter that way.

The existing commercial products cannot be used, either, 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 assume its occurrence).

Miro - Birth World

Joan Miro – Birth World

Consequently, those techniques cannot distinguish between 2 or 3 days before and the day of ovulation. This is to try for a boy or for a girl, respectively, or to TTC, or to avoid conception. The commercially available technologies do not detect ovulation independently of the one predictive element they test for – or two such elements, LH and E2, in the case of the urine-analyzing gadget now sold by Inverness/SPD GmbH. It is not unlike groping in the dark… The other electronic gadget 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 your old BBT method 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 at that).

The thing that the old *Imperfect Measures* tools detect is an input in the hormone signaling mechanism they talk about but of which mechanism they monitor merely that one input hormone signal (or two). However, the boundaries of the fertile window are not single hormone events; hormone monitoring (direct or indirect) cannot define the fertile window.

The existing products do not determine the fertile window of 3 days because they monitor this or that remote parameter that only reflects some aspect of the process that culminates in ovulation. They only detect a hormone signal that says “ovulation can happen about now” (LH), or a signal that says “ovulation has occurred” (BBT); or some reflect estrogen (e.g., through saliva appearance). Estrogen elevates before LH but not far enough ahead, and certainly it does not indicate the start of the fertile window nor the end of the window, which is ovulation. A saliva property is a fuzzy detector of estrogen, much like the vaginal fluid’s tactile and visual examination practiced in some circles.

Clock Explosion by Salvador Dali

Clock Explosion by Salvador Dali

Significantly, the hormones that anticipate ovulation do not mean that ovulation occurs right away or even at all. They just signal that the body is ready. It is essential to actually detect the occurrence of ovulation independently of prediction, and only our technology does that. Stress often either delays or even prevents ovulation, and only the Ovulona™ detects this. You can again find some earlier posts with more details about this.

There are also earlier posts about the variability of ovulation times from cycle to cycle in the same woman (as well as across a population), and 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 the old techniques referenced here, plus or minus 3 days.

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

Ovulona prototype detects delayed ovulation

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 agree 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 another post in this blog, we 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 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.

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 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 women

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 are in all these cycles lower than the O values, 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 self-diagnostic 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.

We can and we do envisage the Ovulona 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. Hormones in body fluids are only of temporary utility for TTC. Against that, FIV (or 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.

See earlier posts in this blog about how symptoms (such as PMS symptoms) vary depending on the day of 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 obstetrics and gynecology in the offing.

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

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

Yes, dear, contingent upon funding… Durer - Witches - 5%

        STOP PRESS

For more information go to 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/

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

October 10, 2009

There: What Women Know

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 such device on the market that would subsequently confirm the pregnancy within days – 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. In fact, 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.

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/2009/10/fertile-window1.jpg?w=600

Fertile window

How? We’ll have the woman monitor at home the process that causes menstrual cycles and is fundamental to women’s health. 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.

Primary use is for 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 useful applications that will come with the core technology.

We show the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle. The graphs 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 cyclic profile has numerous repeatable features.

2. The range of readings 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 phenomena (folliculogenesis).

The significance of these profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology.

https://biozhena.files.wordpress.com/2009/10/fertile-window-for-birth-control.jpg?w=600

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 a sense of what is going on here:

https://biozhena.files.wordpress.com/2009/10/baseline-cycles-interpreted.jpg?w=600

Baseline cycles interpreted

Not included in this illustration is the 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 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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Parties with an interest relevant to bioZhena Corporation will be provided with more confidential information upon request (email: vaclav@biozhena.com). Visit the company at http://www.biozhena.com/ .

The Ovulona™

December 11, 2007

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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