MedTech Investor: Check Out the Assumptions of Our Minimum Viable Product Scenario

In the present post, we present the bioZhena Business Assumptions. This is to draw attention to the big picture that emerges even in the Minimum Viable Scenario (MVS), the detailed assumptions of which have been worked from bottom up (with due attention to the TAM, SAM and the SOM). bioZhena Corporation’s goal is to implement the Full Value Scenario that was constructed based on the MVS. More on this in the closing paragraph of this post.

Now it’s the latter I am reaching out to. And I refer to Home Page of bioZhena’s Weblog to be reviewed in connection with the business assumptions. (Or Reproductive Health IQ Does Matter, a LinkedIn post.)

Here is a summary of the MVS, the Minimum Viable Product Scenario:

SUMMARY OF MINIMUM VIABLE SCENARIO’S SERVICEABLE AVAILABLE MARKET IN THE U.S. ALONE

US Trying-To-Conceive (TTC) Serviceable Available Market $$ at the TTC mean cost of $2,600 p.a. is $21,320,000,000

US Trying-To-Conceive Serviceable Available Market $$ at the TTC minimum cost of $200 p.a. is $1,640,000,000

US Initial Off-Label Birth Control Serviceable Available Market (SAM) $$ is $82,492,000

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Projection: FIRST PRODUCT SALES IN MONTH 16 POST FUNDING (first product application already FDA-cleared)

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Summary Comparison of Minimum Viable Scenario (MVS) with Full Value Scenario (FVS)

Click on the image for better legibility

(the URL is: https://biozhena.files.wordpress.com/2016/09/comparison-mvs-cf-fvs.pps )

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And now for the assumptions – with pictorial embellishments for dividers between the market segments.

Listing sources of market data (with some comments) followed by the resulting numerical USD market size assumptions.

‘Satyre et Bacchante’ by Jean-Jacques Pradier, marble, Palais des Beaux-Arts, Lille.

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Birth Control (BC) Market

CDC 2014 survey: 61.7% of the 60.9 million US women ages 15-49 practice contraception (= 37.6 million contraceptors), and of these 48.1% use the most common methods (the pill, sterilization, condoms, and long-acting reversible contraceptives). That leaves 38.3% or 23.32 million non-contracepting women.

un.org Trends in Contraceptive Use Worldwide 2015 Report, Annex Table II: Number of US married or in-union women using contraception = 28,600,000. Number of US women who have an unmet need for family planning = 2,560,000. Worldwide number of women using contraception is 758,000,000 and the number of women who have an unmet need for family planning is 142,000,000 (these are median data as of 2015). Couples often desire to control not just the number of children, but also the timing. We address this desire or need by design.

Next, per Guttmacher Institute 2016 fact sheet, nearly half (45% or 2.8 million) of the 6.1 million pregnancies in the U.S. were unintended in 2011 (and 42% of those ended in abortion). Contraceptive failure rate plays a big role in this. Meaning that, for 2.8 million of the 37.6 million contracepting women, their method fails (and they seek a solution). 43 million US women were at risk of unintended pregnancy in 2008. (Public expenditures on unintended pregnancies nationwide were estimated to be $21.0 billion in 2010.)

For this Minimum Value Scenario, the conservative assessment of the number of US women in the birth control market is to choose between the 43 million at risk in 2008 and the 2.8 million of unintended pregnancies in 2011 plus the 2,560,000 who have an unmet need for family planning. We choose the latter, which is much smaller, i.e. 2,800,000 plus 2,560,000 = 5,360,000 as the number of US women in the family planning (BC) market segment for our Serviceable Available Market. This is an indisputably conservative assessment of our Serviceable Obtainable Market in the birth control (BC) market segment in the U.S.

US costs of personal birth control average $1,006/year (Health Aff (Millwood) 2015 and americanprogress.org 2012). Since average ACA saving was 20%, then 100% = $ 251.5 times 5 = $ 1,257.50.  So, $ 1,257.5 – $ 251.50 = $1,006. (ACA = Affordable Care Act.) Double-check the reasonableness via this tweet.

Hence Our Birth Control (BC) Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Women in the family planning (BC) market is 5,360,000

US Serviceable Available Market (SAM) $$ is $5,392,160,000

Worldwide Number of Women in the family planning (BC) market is 758,000,000

Worldwide Total Available Market $$ is very large even with only the unmet-need number of 142,000,000 women

E.g. if the estimate is based on the above US cost average, TAM is $142,852,000,000

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Initial Off-Label BC Market Upon the Ovulona Launch Assumed At 1%

Commercial market research compendium reports: The Trying-To-Conceive (TTC) tests are utilized for the unauthorized off-label use of aiding women’s natural birth control practice.

Quote: “About Half Who Use Tests Do Not Want Pregnancy”.

(http://www.marketresearch.com/Packaged-Facts-v768/Home-Medical-Tests-143386/).

Here we assume only 1% of the 8,200,000 US Fertility-Impaired Women Ages 15-44 (see below the CDC data on the TTC market), which is 82,000 women, translating at the assumed mean annual BC cost of $1,006 into an off-label $82,492,000 SAM upon the Ovulona launch into the TTC Market. To reiterate, we assume that 1% of those in the market for a tech tool aiding conception are in fact in the market to help themselves to avoid pregnancy by fertility awareness and will be off-label Ovulona users as soon as the Ovulona becomes available in the marketplace.

This is a reasonable conservative assumption in view of the 69.5 million US Catholics (the largest religious body in the United States) comprising 22% of the population^[1] as of 2015. The assumed 82,000 women represent a mere 0.1% of the Catholic population. See an example of unsolicited expression of interest in the Ovulona from a US Catholic. Ovulona market research with 5,000 US women revealed that 70% of those who would buy the Ovulona would switch from their present contraception method.

The assumed SAM [Serviceable Available Market] number of $82,492,000  represents 30.5% (but read on) of the annual retail sales of ovulation prediction kits (OPKs or LH kits) in the U.S. as they were reported in 2008/2009 when OPKs outpaced the annual sales of home pregnancy tests. The NYT article at http://www.nytimes.com/2009/04/02/business/media/02adco.html?_r=2 cited the annual OPK sales data of $270 million from IRI (Information Resources, Inc.). They derived it from in-store scanners at the retailer level for all of their major CPG clients (Consumer Packaged Goods companies) except for Wal-Mart. This info courtesy of Edward Saettone (via Linkedin Answers).

At annual growth rate of over 10% for personalized diagnostic tools (per PricewaterhouseCoopers), this suggests a SAM over $560,000,000 in 2016, and the assumed off-label SAM of $82,492,000 then represents ~15% of this documented and extrapolated figure for annual sales of OPKs in 2016. The SAM percentage (~15%) will be further reduced by the sales of the electronic ovulation predictor tests that have entered the market in the last decade or so.

For the worldwide assumption we take as base 6% of the worldwide number (758,000,000) minus the number in least developed countries (60,800,000) because: 1.  Only 6 per cent of married or in-union women worldwide used rhythm or withdrawal in 2015 (per un.org …/trendsContraceptiveUse2015Report.pdf), and 2. it is well known that especially this sub-population of women (and men) keep looking for a better tool to help them practice fertility awareness/natural family planning.  6% of 697,200,000 = 41,832,000.

Hence Our Numerical Assumptions For Off-Label Use In the Minimum Value Scenario Are:

Number of US Women off-label users upon device launch into the TTC Market segment (below) is 82,000

US Off-Label Serviceable Available Market $$ is $82,492,000

Worldwide Number of Women off-label users upon device launch is 41,832,000

Worldwide Total Available Market $$ is very large

E.g. if the estimate were based on the above US cost average, TAM is $42,082,992,000

 

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Trying-To-Conceive (TTC) Market

CDC PUBLIC HEALTH GRAND ROUNDS 2015, slide 36 titled “Impact of Lack of Insurance on Decision-Making”: Non-ART: $200 – $5,000 (and IVF: $10,000 – $15,000). Out-of-pocket costs can be substantial and impact patient decision-making and risk-taking – referring particularly to the IVF. (ART stands for Artificial Reproductive Technologies such as IVF, In Vitro Fertilization). We take $2,600 as the mean annual cost of TTC (Trying-To-Conceive, non-ART).

CDC Reproductive Health data last updated 2015: Number of US women ages 15-44 with impaired ability to get pregnant or carry a baby to term: 6.7 million or 10.9%. Number of US married women ages 15-44 who are infertile (unable to get pregnant after at least 12 consecutive months of unprotected sex): 1.5 million or 6.0%. The sum of the primary and secondary infertility sufferers in the U.S. is 8.2 million women. (Secondary infertility means that the mother has one child but cannot conceive for another.)

NIH Analysis of 277 Surveys 2012: Worldwide in 2010, 48.5 million couples were unable to have a child, of which 19.2 million couples were unable to have a first child (primary infertility), and 29.3 million couples were unable to have an additional child (secondary infertility, and the figure excludes China). Due to population growth, the number of couples suffering from infertility has increased since 1990, when 42.0 million couples were unable to have a child. Also, from WHO Evaluation Of Surveys 2004: More than 186 million ever-married women of reproductive age in developing countries were maintaining a “child wish”, translating into one in every four couples or 25%. We note this but opt for the NIH data, above.

Hence Our TTC Numerical Assumptions For the Minimum Value Scenario Are:

Number of US Fertility-Impaired Women Ages 15-44 is 8,200,000

US Serviceable Available Market $$ (at the TTC mean cost of $2,600 p.a.) is $21,320,000,000

US Serviceable Available Market $$ (at the TTC minimum cost of $200 p.a.) is $1,640,000,000

Worldwide Number of Women Who Are Unable to Have a Child is 48,500,000

Worldwide Total Available Market $$ is very large

E.g. if the estimate were based on the US non-ART cost average of $2,600 (see above), TAM is $126,100,000,000

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In closing, the reader is reminded that the above are the Assumptions for the bioZhena Minimum Value Scenario (Minimum Viable Product Scenario), which scenario represents the proverbial “low hanging fruit”. This is because our core product’s first application has FDA 510k clearance for aiding conception and for generating diagnostic menstrual profiles for physicians.

Our goal is to pursue the Full Value Scenario of the bioZhena Business Plan because of the potential of the bioZhena technology – summarized in the single slide here (the URL is:

https://biozhena.files.wordpress.com/2016/08/single-slide-biozhena-technology-potential-on-white-background1.pps ).

We aim to go well beyond personal reproductive management (which is, admittedly, where it all started, as evident from the whole bioZhena’s Weblog and our other web presence).

And for Investors – About PPM with business plan see https://biozhena.wordpress.com/and-for-investors-ppm/

And for more, you might check out  Home Page of bioZhena’s Weblog

bioZhena venture

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

Empower women with clear menstrual cycle data vs. drugging healthy women & the iatrogenic consequences.

This is the first (sex-life management) application providing a superior (definitive) tool with which to tackle the ever-growing difficulty of getting pregnant when planned. And using the same tool for hormone-free, non-interventional, pregnancy avoidance. And, making available the 5th vital sign menstrual cycle profile signature to physicians when needed, for better diagnosis and management of health issues.

Also unprecedented and important for public health is our way of monitoring inconspicuously at the same self-check time the woman’s cervical health – at home. This will work in the background of the primary process, not bothering the user unless a tissue aberration is detected consistently several months in a row. This way of innocuous screening, and its affordability, should significantly improve on the Pap smear screening test.

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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But 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, grasp the significance:

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

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But then my gynecology colleague would argue that the other major healthcare front is even more important. Namely, our way of providing to the women’s healthcare professionals access to the menstrual cycle vital sign longitudinal records, which Dr. Kim likened to the cardiologists’ ECG recordings – but with the important advantage of being affordably and routinely generated by patients at home (and saved in the sensor).

This other major front is providing to the healthcare system the means of obtaining a handle on the management of gynecologic and obstetric medical issues that require better diagnostic evidence for more effective and preventative therapies. In brief, we are answering the call and challenge to “Improve the methods and criteria to assess ovulatory dysfunction” (per R.S. Legro MD, 2013), and more.

Current modalities to diagnose preterm labor cannot detect the early biochemical changes of the cervix which result in dilation that leads to preterm births. Once the advanced signs of preterm labor are found, remedies to stop it are often futile and always costly for the healthcare system ($26B annually in USA alone), and frequently have adverse long-term consequences for the prematurely-born child and the family.

https://biozhena.files.wordpress.com/2014/11/impedence-beyond-cervical-length.pdf

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The bioZhena technology will alert the women-users and their healthcare providers on a timely basis to the onset of pregnancy-related conditions such as normal and preterm labor. And the immediate detection of pregnancy, whether intended or unintended, is automatic with the primary routine use of the home-use smart sensor. That is a notable advantage over the current home pregnancy tests!

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Summing up, read an overview Feasibility of the Planned Range of Ovulona™ Applications

https://biozhena.files.wordpress.com/2014/11/feasibility-of-the-planned-range-of-ovulona-applications1.pdf

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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 (5-year Business Plan Summary Financial Projections)

Or, better,

10-year projections:

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

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

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From bioZhena’s pitch on EquityNet:

Women’s personal sex-life management tool 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.

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

(slides take a few moments to open).

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Contra Nescience Contra Insouciance (SM 2015)

The Home Page of bioZhena’s Weblog offers further particulars (click the link, which translates as “Against Ignorance Against Indifference”)

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

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women’s health, reproductive management | Scoop.it

chagall_nativite_nesign.jpg

For a scoop of my 2015 blog posts on LinkedIn and a couple of other social media, click here: women’s health, reproductive management | Scoop.it.

If my Good Friday philippic denouncing the Pill and its consequences https://lnkd.in/bPZVWKV makes you wonder how all this could be possible, think of the history of the Pill development and use.

History: The Great Bluff That Led To A ‘Magical’ Pill And A Sexual Revolution http://www.npr.org/blogs/health/2014/10/07/354103536/the-great-bluff-that-lead-to-a-magical-pill-and-a-sexual-revolution.

Development & use: Why too many young and not so young ladies could NOT receive flowers on Mothers’ Day: Why so many trying-to-conceive, why so much infertility https://biozhena.wordpress.com/2012/05/14/why-too-many-young-and-not-so-young-ladies-could-not-receive-flowers-on-mothers-day-why-so-many-trying-to-conceive-why-so-much-infertility/

The short URL above, https://lnkd.in/bPZVWKV, stands for http://biozhena.tumblr.com/post/113125522418/recap-2-reason-why-a-non-hormonal-birth-control  Recap #2 reason why a non-hormonal birth control option is a good idea: It’s not all in the head – the bad effects of the Pill.

And the motto in my profile is Contra Nescience Contra Insouciance. It stands for Against Ignorance Against Indifference.

End of the year, and trying to get pregnant

Now, at the end of the year, …

“…Josef Lada did far more than illustrate the Hasek’s Good Soldier Svejk novel, and his idealized paintings of carol singers and family gatherings are, for many in this country, an enduring symbol of Czech Christmas.” http://www.radio.cz/en/section/curraffrs/josef-ladas-paintings-an-enduring-symbol-of-czech-christmas/pictures/obrazy/lada-josef/vanoce.jpg

…the stat counters monitoring the visits to the posts of bioZhena’s Weblog show something that I want to share with you. Namely: The most visited blog posts at this time of the year are those addressing the issues involved in trying to conceive (the flip side of natural birth control). Those blog articles exhibit distinctly higher viewing statistics than the stats of the posts on other topics of reproductive health – whereby some of those topics exhibit a different seasonality of increased interest.

If you wish to put this in context and review the situation out there, outside of bioZhena’s Weblog, read the attached paper Google evidence of increasing prevalence of subfertility.

A couple of examples of the bioZhena’s Weblog titles most visited at this time of the year:

The fallacy of ovulation calculators, calendars and circulating-hormone detectors = https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/ Don’t let them lead you by the nose with likely this and probable that! You need to know for sure.

Critique of birth control efficacies in NFP as published by Marquette University researchers = https://biozhena.wordpress.com/2010/03/23/critique-of-birth-control-efficacies-in-nfp-as-published-by-marquette-university-researchers/ Comments on a report of two studies http://www.usccb.org/prolife/issues/nfp/cmr_winter-spring09.pdf – they report on what we will call peri-ovulation methodologies.

Some women email me, while some “like” certain Ovulona pages or bioZhena’s Weblog posts.

Citing from one such email: “I am a 41 year old nulliparous woman in good health (with a few minor issues). I have been TTC for 1 year without success and came across Ovulona by accident during a Google search for how to optimise my fertility.”  TTC stands for Trying To Conceive, a standard acronym in the community of sub-fertility sufferers. Or even infertility sufferers – those who have not conceived while trying for longer than a year. (Re: Medical definitions of sub-fertility and infertility.) Nulliparous means no children, medical adjective for women having no previous births.

You know, my dear reader, that the optimal age for conception and motherhood is 20 to 24 years, after which fertility starts declining, and it drops a lot after 35 years of age. Should this be news to you, read The perils of IVF, of ARTs, of giving birth at old maternal age . “About epigenetic evidence that should make you think twice+ before you contemplate In Vitro Fertilization and think that having a baby can wait. The bottom line? Be a young mother!”

And from another reader’s email: “Please let me know if there is any way to buy an Ovulona or to use one for trial purposes.”

In response, I can only explain – apologetically, suppressing frustration – that we do not have any Ovulona units available because we have not yet manufactured the marketable product, due to lack of capital. Then, attempting a little more positive note, I remind the would-be Mums about what some experts call “focused intercourse” – that is focusing on trying to hit the fertile window. In the absence of the Ovulona, this must be done preferably with more than one of the several available methods (several, because they are unreliable, inaccurate – don’t rely on any one of them alone). And I urge you to also avoid stress…

Although the old imperfect methods (including instrumental monitoring of urine samples and/or of the BBT) give only inaccurate estimates, they should help to focus on the right time when the probability of conception exists. Outside of the fertile window you don’t have a chance to conceive.

Here is to illustrate two such imperfect methods in comparison with ours (where our Ovulona not only anticipates but also detects ovulation, which detection is all important): https://biozhena.wordpress.com/2007/12/16/cervix-uteri-and-seven-or-eight-related-things/marquette-comparison-with-lh-kit-and-peak-mucus-2/ .

In this record of a 42-years old woman, our device detected delayed ovulation on cycle day 17, while two other methods estimated ovulation from day 16 to day 18. This lack of precision and accuracy is not at all good for natural birth control and/or for trying to achieve fetal gender pre-selection (= trying to conceive specifically a boy or specifically a girl). But, with such inaccurate methods, which are available now before we bring the Ovulona into the market, you can see here that you might be fortunate and hit on at least a part of the fertile window. In this example (because of the ovulation delay), the LH-indicated days 16 and 17 were fertile days because the sperm are viable for about 3 days. Perhaps even day 18 may have been a fertile day, if the ovum (egg) lived long enough, and depending on when exactly on day 17 the detected ovulation occurred (morning or evening?). Such uncertainties will be removed by properly designed experiments with the properly designed Ovulona.

This record from a comparative study shows how the old ovulation prediction methods are unreliable, because the two used here predicted ovulation for 3 different days – but the record may also serve to illustrate for you that (and how) you may be lucky and hit at least one of the fertile days. Here, in this record, ovulation was detected – not merely anticipated – by the Ovulona prototype. It was detected on the day of the second urinary LH indication, which is here one day before the esoteric Peak mucus of NFP aficionados; they did not use the BBT in this study. None of the old techniques detects ovulation: they predict it or, in the case of the BBT, indicate that ovulation has occurred.

There are only 3 days in each menstrual cycle during which pregnancy can occur, and it will if you are fortunate. The 3 fertile days are the day of ovulation plus the two days immediately before ovulation.

I’ll now write a long sentence full of the word “trying”, with several connotations. Repeat after me (and grasp what follows): Trying to determine the 3 days of the fertile window without the Ovulona is pretty much impossible, but trying for it – or at least some of it – is better than trying completely in the dark.

That’s because the 3-day fertile window varies, it does not stay put on certain days of the menstrual cycle from one cycle to the next. Check out this earlier bioZhena post for evidence that this is so. See evidence generated by other experts years or rather decades ago – when they hoped that microcomputer-assisted basal body temperature [BBT] monitoring would solve the problem.

From a graph such as the one above, it is evident that to determine the fertile days before ovulation is more difficult than estimating the last fertile day, which is the day of ovulation. This difficulty is a well recognized fact, and it’s not a matter of whether ovulation is or is not delayed by stress of one kind or another. The stress-caused delay (or even complete suppression) of ovulation is one of the things that complicate management of reproductive life.

Now for the encouragement: Maybe, the idea of not being completely at the mercy of chance when trying to conceive a baby, might even help you to be less stressed out about it at a time when celebrating the end of the year (and looking back and looking forward – along with all that Christmas rush) leads to an increased level of stress anyway.

Josef Lada’s idyllic take on Christmas activities in the countryside and in the city, that is to say, in Czechoslovak towns of his day. There, a fish meal on Christmas Eve was and still is one of the traditions, although the country is now two (and good friends). The fishy thing was apparently based on the belief that fish scales symbolize the prospect of money next year to the eater. Maybe some of us should not have turned our nose up about this fish thing… Then the capital for the Ovulona might not have been so slow coming! Mea culpa, mea maxima culpa!

Perhaps the focus idea may help you not to be stressed out about the thing which is supposed to be pleasurable and not a chore. Suppose that between now and some time in January/February (in the course of the long winter evenings, “za dlouhych zimnich veceru”) you’ll get your focusing organized. You surely will get over the holidays, too… Then, with a bit of happiness, relaxation and luck, come next October you will have the kind of happiness you wish for! And you’ll thus contribute to the birth/delivery statistics for October…

Josef Lada’s calendar illustration for October (c. 1940s)

In this picture, Josef Lada illustrated, long time ago, the characteristics of the month of October. Among them is the rut of the elk, which had given the month its name in the artist’s language. Way back, in those days – the pre-contraceptive Pill days, years and centuries – the difficulty to become pregnant was not a widespread phenomenon, and Mums were  younger than many are nowadays.

The evolution of subfertility and infertility (as a big-time societal phenomenon) in the U.S. is summarized based on data from http://www.infoplease.com/ipa/A0005074.html#ixzz2GBMSkUKy  [Information Please® Database, © 2007 Pearson Education, Inc.] in the next post.

Smoking affects the menstrual cyclic profile as captured by the Ovulona™, monitoring might help with smoking-cessation

80 percent of the 201,773 women who die prematurely from tobacco-related illnesses each year began smoking while they were adolescents. Evidence shows that those young people, who begin to use tobacco, do not understand the nature of the addiction. They believe they will be able to avoid the harmful consequences of tobacco use. They don’t know that “some researchers feel nicotine is as addictive as heroin. In fact, nicotine has actions similar to heroin and cocaine, and the chemical affects the same area of the brain.”

As someone has written, when most girls begin smoking, they are usually caught up in the immediate experience of what appears to be a “cool”, “adult”, or even “glamorous” behavior. They are naive about the powerful addictive nature of nicotine, which, for some adolescents, takes hold after only a few cigarettes.  Among those who had tried to quit smoking, 82 percent were unable to do so.

Alfons Mucha – Job, 1896      Previously shown in https://biozhena.wordpress.com/2010/05/25/difficult-conception-tied-to-pregnancy-complications-addressed/

The tobacco industry spends vast sums of money on persuading people to take up or continue smoking. In its own words, the industry is “a monster which has to be fed”. The industry sees women as a territory to be conquered, and a large portion of the total marketing expenditure is aimed in their direction.

Women appear to be more susceptible to the addictive properties of nicotine and have a slower metabolic clearance of nicotine from their bodies than do men. Women also appear to be more susceptible to the effects of tobacco carcinogens than men, including higher rates of lung cancer.

Girls and women are significantly more likely than boys and men to feel dependent on cigarettes, and more likely to report being unable to cut down on smoking. While various smoking-cessation treatments and strategies appear to work similarly for both sexes, women may face different stressors and barriers to quitting smoking, such as greater likelihood of depression, weight control concerns, and child-care and family issues.

It is estimated that about 30% of deaths from cervical cancer are caused by smoking. Smoking and taking the Pill in combination can increase the risk of heart disease by up to ten times.

Jiří Anderle, Láska za lásku / Love for Love lept, pastel / etching, pastel, 1996, opus 535, 13 x 17 cm 7.400,- Kč / CZK

Smoking is damaging to women’s reproductive health. It is associated with infertility, complications during pregnancy, and an earlier onset of menopause.

The estimated 20 percent of pregnant women who smoke during their pregnancies subject themselves and their fetuses and newborns to significant health risks, including miscarriage, stillbirth, pre-term delivery, low birth weight infants, and higher rates of infant mortality.

Smoking while pregnant has serious effects on the health of the baby. Untold adverse consequences affect the lives of those children and the people around them. A study from the Centers for Disease Control and Prevention (CDC) reports that smoking during pregnancy also increases the risk by 50 percent of having a child with mental retardation; this increased risk rises up to 85 percent among those who smoke a pack or more of cigarettes each day. The risk for Sudden Infant Death Syndrome (SIDS) increases among infants who are exposed to intra-uterine smoke and to second-hand smoke after pregnancy.

The younger an adolescent is when she begins to smoke, the more severe her nicotine addiction is likely to be. Additional health effects of smoking are: respiratory problems (and decreased physical fitness), dental problems (including periodontal degeneration), coronary artery disease, mental health effects (including nervousness, depression, more high-risk behavior, etc.), health-damaging behaviors, and other negative effects on quality of life (bad breath, wrinkled skin, stained teeth, and other negative effects that influence how she looks and feels).

We have preliminary evidence on how the smoker’s lifestyle affects the FIV™ menstrual cyclic profile captured by the Ovulona™.

Baseline cyclic profile of a healthy 30-years old non-smoker woman (who, as a baseline subject, is not taking any medication or contraception) shown here between two cyclic profiles of a smoking mother. The baseline profile was taken twice a day, morning and evening, and the AM and PM records show not only the reproducibility but also how the post-ovulation follicular waves develop between the morning and evening hours. The smoker’s consecutive profiles are similar to the baseline but exhibit significant differences. Cycle 4 record captured a delayed ovulation and short luteal phase. Cycle 5 shows also a short luteal phase, an abnormality (the luteal phase should be about 14 days long, give or take a day or two).

Image file URL: https://biozhena.wordpress.com/2012/02/21/smoking-affects-the-menstrual-cyclic-profile-as-captured-by-the-ovulona-which-might-help-with-smoking-cessation/non-baseline-profiles-flanking-baseline-subjects-ampm-profile-t/

We can imagine that a young woman trying to quit smoking may be helped in her effort by the Ovulona device. The Ovulona could be prospectively proffered for that purpose as a kind of biofeedback tool.

It is envisaged that tobacco interference with the fertility cycle will be recognized and accepted as a powerful motivator in the hard battle with the extremely strong addiction. “Is appearing ‘cool’ worth the resulting difficulty in getting pregnant, having a healthy baby?”

With public health education, the healthcare providers will be able to use the FIV cyclic profiles of the addicted patients to point out the affected features, and to monitor effects of treatment. “We really want to see this part of your cyclic profile to look more like this…”

Seven billion people – after half a century with the Pill

More than a week before the numerologically so exciting (!!) date of November 11 this year of AD 2011, the population of the world officially reached the count of 7 billion – and this should not go unnoticed in a blog that is about women’s health and human reproduction management. Why, by the time the 11-11-11 day came about, more than 2.5 million more babies were born around the world.

Eyeball the “infographic” data below here, accepting that the image contains one of the small European languages. You can handle this because it is a graphic representation of the world and its population. The data is based on a United Nations Report about the State of the World Population. I did not find anything like this infographic when I googled for said UN report, and the bigger languages of Europe were presumably preoccupied by other concerns (like the economy, and the associated politics, stupid…).

So, we refer to this source with all those un-English letters with diacritical marks [RB, Lidové noviny. From: http://www.lidovky.cz/je-nas-7-miliard-lidstvo-v-budoucnu-uzivi-jen-zemedelska-revoluce-phq-/ln_zahranici.asp?c=A111031_085513_firmy-trhy_mev ]. It’s the numbers and symbols that matter, including the relative sizes of the circles. And note also that the blue circles represent the size of the respective continents’ populations in 2010 versus the red projected population sizes in the year 2050.

By 2050, only Europe’s population will have decreased (projected by 19 million), while all the other continents’ populations will have continued to grow. North America’s population, by the way, is projected to grow only due to immigration, otherwise it would be dropping, too. At least the USA’s would.

World population

http://www.lidovky.cz/foto.asp?foto1=MEV3ed992_2poulaceTTTa.png

12 years times 365 days/year = 4,380 days

Population growth = 1,000,000,000 people / 4,380 days =  228,310.5 people born per day  (2,511,415.5 babies in 11 days = 1 billion divided by 4,380 days in 12 years times 11 days)

Check out the arithmetic of the global population growth in recent days, if you like. It is based on the birth rate of 1 billion births per 12 years. That is indicated in the bottom part of the infographic, showing the worldwide number of people in increasing billions against the years at which the given billion count was reached up to now, and is projected to be reached in the future [rok means year and pocet obyvatel means number of people]. It’s noticeable that the UN-projected future growth rate slows down: see how 16, 29, 27 years between additional billion increments are projected for the next 3 one-billion increments.

I won’t go into the (serious) economic and political consequences of these numbers. Rather, I ask you to note that the current birth rate (1 billion per 12 years) has held steady for the last 3 or 4 one-billion increases in world population. Over most of the last half a century, world population grew in steps of one billion per 12 years.

We see that reaching the first billion of humans took more than 18 centuries (including BC). The second billion then took 123 years and the third 33 years, both these surely influenced by the two world wars. After that, the Pill notwithstanding, almost quarter of a million new people have been and are born globally every day (1B / 4,380 days of 12 years = 228,310.5 births per day).

Evidently, the introduction of the oral contraceptive pills and related contraceptives has NOT quite stopped the global population explosion. But then, what about the United Nations-projected drop in the population of Europe (which is a continent where the Pill is surely available)?

Well, I propose to share with you some data from Google Ngram Viewer, about the statistics on the recent historical occurrence of certain topics (such as contraception) in all books published in English, the data obtained via http://books.google.com/ngrams/info .

Briefly, when you enter phrases into the Google Books Ngram Viewer, it displays a graph showing how much those phrases have occurred in a corpus of books (here English-language books) over the selected years (here 1900 to 2008).

And an important point, also cited from there.

Question: Many more books are published in modern years. Doesn’t this skew the results?

Answer: It would if we didn’t normalize by the number of books published in each year.

Here is an example of the occurrence of three phrases (topics) in English-language books over the century from 1900 till 2008, the latest year available. The topics are: pregnancy complications, difficult birth, and birth complications.

Ngram 1: pregnancy complications, difficult birth, birth complications

http://books.google.com/ngrams/graph?content=pregnancy+complications%2Cdifficult+birth%2Cbirth+complications&year_start=1900&year_end=2008&corpus=0&smoothing=5

The N numbers (or the number of phrase occurrences relative to all books) for the three topics are on the same scale as indicated on the vertical axis, and the graph shows that the number of books on difficult birth (red curve) rose steadily over the century – but the books on pregnancy complications (blue curve) and birth complications (green curve) shot up after 1960. These N numbers eventually level off and/or begin to decline after the year 2000. (As though everything has been written up, nothing new to publish?)

There were many more books written about birth control over the same period of 108 years. We can detect this in the N count on the vertical axis, which here has only 3 leading zeros as opposed to the 5 leading zeros at the maximum level in the previous graph (a hundred times as many books, even in 2008, after the decline from the mid-1970s). The initial rise from 1910 to 1930 must have been not on chemical contraception but (mostly) on the then happening calendar method of Ogino and Knaus, i.e. the later discarded so-called “Vatican Roulette”. That approach to birth control did not work – it could not work – so Margaret Sanger took it on herself (and on her wealthy-widow friend, Katharine McCormick) to cause the “magic bullet” of a pill to be developed. Some magic!

Ngram 2: birth control

http://books.google.com/ngrams/graph?content=birth+control&year_start=1900&year_end=2008&corpus=0&smoothing=3

One more Ngram Viewer graph, since they say that three is a charm! The following graph compares the number of books on infertility (blue) with the number of books on contraception (red), and it is on the same scale as the birth control graph above (with only slightly lower maximum level, 0.00035% here vs. 0.00045% above).

Ngram 3: infertility and contraception

http://books.google.com/ngrams/graph?content=infertility%2Ccontraception&year_start=1900&year_end=2008&corpus=0&smoothing=3

Three may be a charm, but I will show you one more, so that you (or your friendly gynecologist) will not accuse me of trying to show that chemical contraception has caused infertility (the infertility epidemic). I have merely shared Google’s Ngram Viewer statistics on books written on given topics. Discourses written on contraception preceded those on infertility by at least 10 years, and the number of infertility books was still rising when contraceptive books were already declining in numbers in the 1980s.

Here then is one more Ngram comparing N numbers of books on behavior problems (blue), mental problems (red), and books on birthing (green curve).

Ngram 4: behavior problems, mental problems, birthing

http://books.google.com/ngrams/graph?content=behavior+problems%2Cmental+problems%2C+birthing&year_start=1900&year_end=2008&corpus=0&smoothing=3

You see that there are four leading zeros in the scale on the vertical axis, so the order of magnitude of the graphed N numbers is between the two orders of magnitude discussed above (it’s an order of magnitude below infertility and contraception). All three of the numbers in this Ngram rise around 1970, behavior problems books before, birthing books after.

Why did the numbers of books on birthing rise so sharply some 15 years after 1960? I don’t know that there is such a thing as invalid questions. The curves for mental health and birth are correlated, rising around 1970, too (not shown here).

Chemical contraception has not worked to reverse the global population explosive growth although it appears to have reduced the extent of the explosion.

But at what cost? Do look at the last Ngram, below, which compares the number of books on birth control (blue), sexually transmitted diseases (red), STD (green), VD (yellow), and STDs (dark blue). It is on the same scale as the birth control graph above (the second in the series). The green spike after 1960 is STD in singular, as opposed to sexually transmitted diseases (red) and STDs (dark blue), which you see rising slowly after 1980, paralleled by the higher green curve in those years, which starts going up even earlier.

This can be rationalized by the fact that earlier on there was merely one STD (or two), called VD in Britain and in Europe (yellow curve), where the rise occurred somewhat later than in the U.S., along with the slight delay in the “sexual revolution” and its consequences or rather the concerns about those consequences. The broad green, red and dark blue hills of elevated N readings before year 2000 reflect the multitude of STDs today, which numbers did not exist before the sexual revolution. The singular VD has morphed into the plural STDs and sexually transmitted diseases.

Ngram 5: birth control, sexually transmitted diseases, STD, VD, STDs

http://books.google.com/ngrams/graph?content=birth+control%2Csexually+transmitted+diseases%2CSTD%2CVD%2CSTDs&year_start=1900&year_end=2008&corpus=0&smoothing=3

I leave the “now what” maybe for another time, but a follower of this blog will have an idea.

As of this writing, to cite the three bioZhena’s Weblog Top Posts (the past week):

Trying to conceive, #ttc, or the frustration of sub-fertility & infertility in 2010/2011          40 views

Saint Nicholas Day, his legend, and our modern day’s prematurity, EDD calculation, gestational age, problem with LMP          33 views

Critique of birth control efficacies in NFP as published by Marquette University researchers          21 views

On the issue of cervical cancer, after remembering Jan Hus – and heresy

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

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 --- 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 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

@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

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.

Honey is Sweeter than Blood by Salavador Dali, 1941

For a woman in her 30s who has 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.

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” – 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 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 woman trying to have a baby. This is a principle of evidence-based medicine. Personalized medicine.

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

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 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

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.

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

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/

More About Clomid, Serophene, Clomiphene citrate or Clomifene

Why popping pills is not the best. This chemicalization of life is a form of enslavement.

Expanding on the previous post, I reiterate what I left off with. It is advisable – and safer – to go about TTC, Trying To Conceive, without the use of chemicals, especially man-made chemicals – and note that herbal preparations are chemicals too. Monitoring (measuring) the effects of anything [any drug] you ingest is basically a must, if you do not play “Russian roulette” with yourself, your offspring, your family.

There is no such thing as a “magic bullet”, and every drug has side effects. It is advisable – and safer – to go about TTC by mastering the natural “right time” approach. The medical establishment has approved of it for birth control, even if not all medical schools teach it. (Go figure.)

Of course, this is the era of popping pills, but it might also be the tail of the era, if web 2 social networking and all that is really here to stay… (Please don’t say, “you wish” about the tail!) The pressure of big pharma advertizing is what makes for said era. In the Middle Ages, they who were accessible to the then lobbying pressures, had things like the Crusades, witch-hunts, and stuff like that. Now, there are different pressures and more customers accessible to them…

An Angel Leading the Crusaders to Jerusalem - Gustave Doré (1832 - 1883)

But, back to Clomid, clomiphene, now spelled clomifene. This http://www.early-pregnancy-tests.com/clomid.html is one of the many websites about the drug. It warns that “…in the case of clomid and FertilityBlend/FertilAid, the product makers do state that clomid should not be taken with herbal products…”.

Looking at the chemistry of the non-steroidal ovulatory stimulant Clomid (or clomifene), http://to.ly/5dn2, and keeping in mind the inevitable occurrence of metabolic biochemistry (drug transformation in the body of the patient), one finds this title:

Stilbenoids: Resveratrol, Tamoxifen, Diethylstilbestrol, Combretastatin, Pterostilbene, Clomifene, Stilbenoid, Combretastatin A-4, Kobophenol A – at http://to.ly/5dm1.

Simply put, these medicinal compounds are differently substituted stilbenes (http://to.ly/5dQa = chemically modified stilbenes [stilbene being an ethene double bond with phenyl groups on both carbon atoms of the double bond]). Here is the pharma business in a nutshell: The different substituents (or modifiers attached to the stilbene molecule) impart different electronic, electrochemical, biochemical and physiological activities. That’s what the pharmaceutical industry explores in or with their products.

Albrecht Durer - Christ among the Doctors. AD 1506.

Then, we have a search for triphenyl ethylene stilbene http://to.ly/5dkt . Some of the search results are as follows – with particular reference to the fourth one below the recumbent woman (where anthropogenic means “caused or produced by humans”, and endocrine, of course, pertains to an endocrine gland or its secretion into blood or lymph):

OESTROGENS AND PRO-OESTROGENS RELATED TO STILBENE AND TRIPHENYLETHYLENE http://joe.endocrinology-journals.org/cgi/content/abstract/3/1/168 . “It has recently been shown [Emmens, 1941, 1942] that oestrogensmay be divided into two classes—those which act directlyor with changes that can be effected locally…” (Yes, shown in the forties.)

Estrogens and antiestrogens I: physiology and mechanisms of action …, Volume 1 (1999) http://to.ly/5dkx . “The most prominent drug amongst these compounds is tamoxifen…”

1993: RU 486—A Decade on Today and Tomorrow http://www.nap.edu/openbook.php?record_id=2203&page=71 . “The development of RU 486¹ (Figure B1.1), the first efficient antiprogestin, may be seen as a result…this meeting, which merged science (hormone research) and the cause des femmes… it became clear that the available contraceptive methods did not completely meet the needs of women and their families; nor would they alone have a sufficient demographic impact… Mifepristone (RU 38486)…”

Albrecht Durer - Draughtsman Drawing a Recumbent Woman. 1525. Woodcut.

Chemistry of Natural and Anthropogenic Endocrine-Active Compounds http://to.ly/5dkG . “…endocrine active compounds comprise both naturally occurring substances and man-made chemicals, and their chemical structures are surprisingly diverse… Phytoestrogens, Industrial Chemicals… The stilbene-type agents diethylstilbestrol (DES), E,E-dienestrol and meso-hexestrol were synthesized in the late 1930s and are among the first man-made estrogens used for human treatment… banned today…  The phenolic A ring of steroidal estrogens has long been considered a prerequisite for estrogenicity… also of paramount importance for the high estrogenic activity of DES and other stilbene-type compounds… it has been observed that numerous other phenols exhibit hormonal activity… potential endocrine disruptors, viz., alkylphenols and bisphenols… prototype of bisphenols is bisphenol A (BPA, Fig. 12), used in large amounts for the production of polycarbonate plastics and epoxy resins… Polychlorinated biphenyls (PCBs) are among the most persistent and ubiquitous environmental pollutants. Whereas the PCBs themselves have no or at best marginal estrogenicity, significant hormonal activity may be entailed to these molecules by hydroxylation [22].”

Albrecht Durer - The Martyrdom of the Ten Thousand. AD 1508

To help make some sense of the above, let the editor of Annals of Internal Medicine (http://to.ly/5dnr ) say this: “…in the field of synthetic substitutes for the female sex hormones, the essential point is the establishment of the fact that estrogenic activity is not exclusively a property of compounds structurally similar to the natural hormones [that is, possessing the phenanthrene nucleus]… a number of simpler substances having estrogenic properties…”

So, again, there is no “magic bullet”, there are inevitable side effects, associated with lack of specificity (the scientific term for “no magic bullet”).

Specific Clomid warnings are, for example, at emedzone site (.com/clomid-brand-tabs-aventis-pharma-p-149.html). To cite: The regimen in which Clomid should be used depends on the individual condition… and if HCG was used mid-cycle or not.

Albrecht Durer - The Dresden Altar. AD 1496

Clomid Warnings

Clomid can cause disturbed vision and blurred vision and therefore should be used with caution…

For those women who are planning to get pregnant, be warned that taking Clomid may result [in] multiple births and this may be harmful to the mother and to the fetus as well. (Note: Multiple births are also a very big problem for public health.)

Clomid may also be not advised for patients with the following medical conditions (note: these are conditions that may have caused the difficulty to conceive in the first place):

• Endocrinal disorders

• Thyroid problems

• Live[r] diseases

• Ovarian cysts and enlargement

• Polycystic ovarian syndrome

• Uterine fibroids

• Any other chronic illnesses

• Endometrial carcinoma

• Vaginal bleeding

If you have any of the above-mentioned diseases, your doctor may advise you not to take Clomid or will significantly alter your dosage.

Clomid is also not advised for pregnant women as it is a drug in the pregnancy category X and may cause birth defects when taken by pregnant women.

Clomid is also not advisable for nursing mothers as it passes into the breast milk and may cause harm to the nursing infant. END QUOTE.

Albrecht Durer - Durer's Wife Agnes

In addition, the use of fertility drugs may be associated with an increased chance of developing ovarian cancer, although there is an ongoing controversy over this: http://to.ly/5dmf , http://www.wordiq.com/definition/Ovarian_cancer .

Such are the reasons why popping pills is not the best. Not to attack big pharma, but all this chemicalization of life is a form of enslavement. More insidious than the slavery that was abolished centuries ago, more subtle. First, make them buy a drug that causes such and such side effects including the least spoken of, the premature aging of the cervix http://to.ly/5dMb ; the ensuing problems are then tackled with other drugs (like clomifene), and on and on it goes.

Let’s contemplate with Albrecht’s wife Agnes why it should be that too many pregnancies were the problem before chemical contraception, whereas today… Today, sub-fertility and infertility are on the up and up, while contraceptive failure statistics are in the picture, too, showing that about half of all pregnancies in the U.S. are unplanned, and that mature population of America uses surgical sterilization for birth control.

This is a man-made problem. See the next post about accelerated atrophy of vital cervical tissues (crypts) due to the man-made problem called the Pill (About atrophy, reproductive aging, and how it’s really not nice to fool Mother Nature – or with). And see the December 2011 post about Difficult to conceive – Google evidence that pregnancy complications and trying-to-conceive concerns shot up after the Pill launch in 1960s (this article reiterates and simplifies the take-home message put forward in the atrophy – aging – Mother Nature post; and two paintings of the Rape of Europa are showed there, too…).