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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bioZhena & Women’s Fertility Watch(ing)

bioZhena & Women’s Fertility Watch(ing)

Let’s bring women’s personal management of sex life (“can I conceive today?”) into the Information Age.

And provide diagnostic vital-sign menstrual profiles to doctors & payers along the way.

https://biozhena.files.wordpress.com/2014/10/ovulona-quick-intro-4-slides1.pps

Recapping why a non-hormonal birth control option for women is a good idea because of the drug’s brain effects

How baby-making late in life evolved into subfertility and infertility, difficult conception, too long TTC

Way back, in the pre-contraceptive Pill days, the difficulty to become pregnant was not a widespread phenomenon, and mums were  younger than many are nowadays. If you want to see graphical proof of how the phenomenon came about in the previous century, review the attached paper Google evidence of increasing prevalence of subfertility. Should you not be a subfertility or infertility sufferer, and therefore not familiar with the acronym, TTC stands for Trying To Conceive.

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

In 1940, births to mothers over 29 years old (30 to 49) were apparently almost as numerous as births to mums of the optimal fertility age 20-24: The ratio of 30-49 years old to the optimal-age group was 0.91 [here referred to as ratio a) =  data for 30–34 plus 35–39 plus 40–44 plus 45–49, this sum divided by data for 20–24], and the number of births in the most fertile age group of mums represented 31% of all births in the U.S.

In case you did not check out the above-linked attachment https://biozhena.files.wordpress.com/2012/12/google-evidence-of-increasing-prevalence-of-subfertility.pdf : The high number of 1940 births to older mothers [high ratio a)] is not so surprising in view of the growing number of books on subfertility and infertility in the 1940s, as seen in the respective Google Ngrams shown here and discussed in the attached PDF paper.

Ngram 3: infertility and contraception

In the present analysis of the historical birth rates, the age group of 25-29 is considered kind of neutral (neither optimal nor too old) whereas the 30-34 years old group is included among the too old ages for optimal fertility. This inclusion could be disputed – if we did not face the subfertility/infertility phenomenon, in which age is a significant factor. In any case, excluding the 30-34 age group from the aged-motherhood definition only delays the trend reversal – observed below in 1980 – by a decade.

I interject here a citation from the post referenced and linked at the end of this post, so that you’ll be well aware of the link between conception difficulties and advancing age, and of the adverse effect of the use of the Pill.

QUOTE: People have a hard time accepting that getting pregnant is not as easy as expected, when they finally decide to want a baby – usually way too late, and after her use of the Pill. The drug makes healthy young women in their best years to postpone family- and baby-making, it damages their cervical S-crypts thus causing difficulty to conceive and, by encouraging promiscuous sex life, it has caused an enormous increase in the prevalence of sexually transmitted diseases that also lead to infertility. Not just a double whammy, a triple whammy on womankind.  Sad, sad, sad. … Advanced age of the would-be Mum works against her on account of the Mother Nature’s Probabilistic Rules and Regulations of Baby-Making… END QUOTE.

An obgyn’s article on female subfertility in the Lancet invokes “two main factors that determine subfertility: duration of childlessness and age of the woman”. It is not likely that an obgyn would be as critical of the Pill as yours truly, although there have been exceptions. No further comment on this is needed or offered in this blog post. Instead, I share that another medical article from Britain reported that “the incidence of infertility was 0.9 couples per 1000 general population. The average age of women was 31 years, and the average time attempting conception was 18 months… At 12 months, 27% of all couples in the study achieved a pregnancy spontaneously and a further 9% with treatment.”

Here are the 1940 US birth statistics data from the referenced infoplease.com source:

Year	Total	Under 15	15–19	20–24	25–29	30–34	35–39	40–44	45–49
1940	2,558,647	3,865	332,667	799,537	693,268	431,468	222,015	68,269	7,558

And this is the calculation for the present analysis of the data:

a) 729,310/799,537 = 0.912

(ratio a is the sum of births to age groups from age 30 to age 49 divided by births to age group 20 – 24)

b) 799,537/2,558,647 =  0.312

(ratio b is births to age group 20 – 24 divided by total births in 1940)

By 1950 and 1960, the trend was good because ratio a) declined from 0.91 to 0.86 and then to 0.80 while the number of optimally aged young mothers rose slightly to 32% and then to 33.5%. These pre-Pill years were good years from this perspective, and the trend continued – even after the contraceptive Pill was introduced (in the 1960s), at least initially.

In 1970, there was a drop in the total number of births from the total of 1960 (4,257,850 births) and a dramatic drop in the number of births by aged mothers [ratio a) was 0.47] – and the births by the most fertile age group were up to 38% of all births. As though the contraceptive Pill worked in this sense (but only if we do not look at the significantly increased births by underage girls, especially the under 15)… Here is the 1970 data from the above source:

Year	Total	Under 15	15–19	20–24	25–29	30–34	35–39	40–44	45–49
1970	3,731,386	11,752	644,708	1,418,874	994,904	427,806	180,244	49,952	3,146

Unfortunately, in 1980 – that’s some 20 years after the Pill was introduced – the trend started to reverse while the total births continued to drop (and underage births dropped, too): Ratio a) of the number of aged mothers’ births to the most fertile age group’s births rose to 0.58 and births by the most fertile 20-24 year old mums represented now only 34% of total US births. The bad trend toward older-age motherhood continued.

By 1990, there were even more births to aging mothers than births to the most fertile age group, with ratio a) standing at 1.15 and the number of births to mothers of the optimal age group having dropped to a mere 26%.

The bad trend continued so that in 2000 advanced-age mothers exceeded the optimal-age group with ratio a) at 1.45, and with the optimally aged mums at 25% of total births. The trend continued further so that in 2009 advanced-age mothers exceeded the optimally aged mums by a factor of 1.53 [= ratio a)] and the optimal age group’s births dropped to 24% of total births. Data for 2009 are the most recent available data.

Tamara de Lempicka Quattrocento, 1937

Is the difference between way back and now the reason for one other elevated readership statistic here on bioZhena’s Weblog? It is intriguing to see that during the months of the highest numbers of US births/deliveries (late summer and autumn, well before the year-end Holiday Season), a highly viewed post this year was the one published around the time of Mother’s Day: 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/ Say thank you to the social and medical advances of the twentieth century – primarily those of chemical birth control, the Pill.

What do you think of all this?

P. S. The Alphabet of bioZhena (glossary/primer) is at https://biozhena.files.wordpress.com/2020/01/aaee-the-alphabet-of-biozhena-011207-with-tracking.pdf

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

Say thank you to the social and medical advances of the twentieth century – primarily those of chemical birth control, the Pill.

Yes, chalk it to the great advancements! Sarcasm aside, indisputable developments in society and in medicine have resulted in the present state of affairs.

Incidentally, “Mothers’ Day (with the plural) is how it was spelled in the U.S. congressional resolution first recognizing it, 9 May 1908”. That was before all this started, before Margaret Sanger wrote “What Every Girl Should Know”, before she started a radical feminist monthly “The Woman Rebel”, and released 100,000 copies of “Family Limitation”. It was before “her confrontational style attracted even greater publicity for herself and the cause of birth control.”

Margaret Sanger
http://www.nyu.edu/projects/sanger/secure/aboutms/index.html
She wanted to liberate women.

Some years later, in the late 1920s – early 1930s, the Japanese Dr. Kyusaku Ogino (Professor at Niigata, Japan) and Dr. Hermann Knaus in Austria (University Women’s Clinic in Graz, Austria) independently discovered that women can conceive only during a brief period “in the middle of the menstrual cycle” [The Eugenics Review: Volume 28, 1936]. But – while this was the fundamental discovery of the menstrual cycle – pretty much right away there was the similarly fundamental criticism that “the so-called safe period of Knaus and Ogino offers very small protection indeed”.

That was because, for reproductive management, “the theories of Knaus and Ogino have not yet been proved sufficiently reliable for us to recommend the so-called safe period as a method of contraception…” although, “if the theory is correct, there will be more likelihood of impregnation at this time.”

Ngram 11 showing the number of English-language books with the phrase Knaus and Ogino between the years 1900 and 2008 (the latest year of available data; at smoothing 3 )
http://books.google.com/ngrams/graph?content=Knaus+and+Ogino&year_start=1900&year_end=2008&corpus=0&smoothing=3
The second, higher, peak is indicative of the relationship between the practical failure of Ogino and Knaus and the inception of the oral contraceptive pill, which provided the answer to the failure.              (For the record, the following 2008 books give good reviews of the Ogino-Knaus story in the history of reproductive management: http://books.google.com/books?id=sqwMrennRsQC&pg=PA205&dq=%22Knaus+and+Ogino%22&hl=en&sa=X&ei=39uzT5uYKeWq2QXGmrDpCA&ved=0CEgQ6AEwAg#v=onepage&q=%22Knaus%20and%20Ogino%22&f=false     AND     http://books.google.com/books?id=RmpMZ7K2L3YC&pg=PA142&dq=%22Knaus+and+Ogino%22&hl=en&sa=X&ei=JsiyT6zXCKbM2AXf3-DpCA&ved=0CEIQ6AEwAQ#v=onepage&q=%22Knaus%20and%20Ogino%22&f=false   —    found via   https://www.google.com/search?q=%22Knaus%20and%20Ogino%22&tbs=bks:1,cdr:1,cd_min:1997,cd_max:2008&lr=lang_en)

Then again, “there is a good deal of evidence to prove the existence of these fertile and sterile periods”, and an author in 1945 “gives his opinion that the period during which the mammalian egg is susceptible to fertilization may be measured”.

It was eventually – only in recent years – recognized that the extent of the fertile period should be only 3 days, and that the basic practical problem was the variability of the menstrual cycle, essentially of the follicular (“proliferative”) phase, the one before ovulation.

However, at the time we were not around with the Ovulona™ to measure the fertile period, and Mrs. Sanger’s zeal took her in the direction of a “magic pill”. In view of the failure of the first effort at natural approach to reproductive management, the so-called rhythm method, her direction is not too surprising because it was the time of great pharmaceutical advances. The chemists had the bandwagon of steroid chemistry to ride and Dr. Gregory Pincus had pioneered in vitro fertilization in the rabbit, for which he was not admired but more or less ostracized.

“In 1953, Margaret Sanger and Katharine McCormick (a heir to major millions of dollars) confronted Pincus with the idea of creating an oral contraceptive”, and the rest is history – of the Pill. History of the oral contraceptive pill and the ensuing sexual revolution. Do check out under P (Pill, the) in the Alphabet of bioZhena, and don’t miss also under M the article about “Mysterious conceptions (OR THE NONEXISTENCE THEREOF)”.

And then – now – there are the consequences of the Pill, one of which translates as the absence of the mother status in the lives of many women desiring motherhood. Those who are unsuccessfully trying to conceive, and so the bouquets of Mothers’ Day are only for their Moms.

Look how there was no infertility and no IVF before contraception. See the blue curve of infertility in the bottom graph, and the green curve of IVF in the top graph of books plotted against the years of the 20th century. See how they go up only years after the rise of contraception (bottom) and after birth control and family planning (top).

Ngrams 12 and 3 together showing the number of English-language books with the phrases birth control, family planning and IVF (Ngram 12, top) and contraception and infertility (Ngram 3, bottom)
between the years 1900 and 2008 (the latest year of available data; at smoothing 3 )
Ngram 3 data from http://books.google.com/ngrams/graph?content=birth+control&year_start=1900&year_end=2008&corpus=0&smoothing=3 , and Ngram 12 data (note: twice as high amplitude, top graph) from http://books.google.com/ngrams/graph?content=birth+control%2Cfamily+planning%2CIVF&year_start=1900&year_end=2008&corpus=0&smoothing=3

I have discussed the consequences of the steroid chemical contraception technology in several posts in this bioZhena’s Weblog. The consequences are numerous because of the far-reaching significance of tinkering with reproductive physiology – consequences for women’s health, and for public health.

Far-reaching consequences because the naturally occurring and functioning hormones, which the contraceptives tinker with, are essential for the functioning of the female organism, for the well-being of every woman.

Check out the Table of Contents = links to bioZhena posts. See, for example:

About atrophy, reproductive aging, and how it’s really not nice to fool Mother Nature – or with (For people outside of NFP [Natural Family Planning] because NFP people know this already)

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!)

Difficult to conceive – Google evidence that pregnancy complications and trying-to-conceive concerns shot up after the Pill launch in 1960s (Regardless of what contraceptive proponents tell you)

Along the way to the unfortunate consequences of the anti-ovulation, anti-conception Pill and its modifications (modified methods of delivery of the chemicals into the female organism) there has been the effort to replace the calendar or rhythm method with different means of prediction of the ovulation day. I am referring to Natural Family Planning (NFP) and/or to the somewhat more recently labeled Fertility Awareness Based Methods (FABMs), one of which is the Fertility Awareness Method (FAM) itself. Fertility awareness – as opposed to the calendar – is key.

Some proponents will include NFP within FABMs and, of course, define NFP as requiring sexual abstinence during the fertile phase (aka fertile window) of the menstrual cycle; as opposed to FAM, which is defined as the use of a barrier method of contraception (such as a condom) during the fertile phase (fertile window).

Either way, the extent of the fertile window has always been THE major issue or rather the issue has always been the need for accurate and reliable determination of the fertile days. Only our Ovulona can determine the mere 3 fertile days due to the lifetimes of the sperm and of the ovum, egg. No other technique can.

Natural Family Planning or more broadly the FABMs cannot win if they continue to rely on what I have called (politely) the peri-ovulation methods of guesstimating the fertile window.

Whether used to assist conception or to avoid it, ovulation calculators, calendars and circulating hormone detectors will not do.

Scientific Fertility Assessment™ based on Follliculogenesis In Vivo™ is the only way to stop the unhealthy chemicalization of reproductive health management.

Gil Bruvel, Relative Time (1993)
http://www.liveinternet.ru/tags/surrealism/page7.html
An interesting title. Each woman has her own biological clock, which responds to her circumstances in every individual menstrual cycle. That is why there is no such thing as cycle regularity (despite the long-held simplistic belief to the contrary).
In 1970, Dr. Hugh J. Davies of Johns Hopkins University told the US Senate in the Nelson Hearings about the contraceptive Pill: “Never before in history have so many people taken such powerful medication with so little information as to its actual and potential risks. …With the introduction of such active ingredients, we are actually setting up a massive endocrinological experiment with millions of healthy women.”

Natural family planning was a significant refinement of the fundamental discovery of Ogino and Knaus, developed as an alternative to the artificial chemical contraception. For decades the NFP proponents, along with OBGYNs and birth control advocates, erred on the (off-putting) long side of guesstimating the fertile window from various signs of the approach of ovulation.

Before it was officially – and incorrectly – decided in 1995 that there were 6 fertile days (all before and including the ovulation day), the period of abstinence required by NFP was advocated as at least 10 or 13 days long. A bit too much, to say the least – and, naturally, without monitoring the variable pre-ovulation phase to quantitatively anticipate ovulation, the failure rate was too high for birth control.

Logically, the same goes for “the other side of the coin”, for conception and pregnancy achievement. Again, please see certain other posts in this blog for more – you’ll recognize the pertinent articles in the table of contents.

One example of such a post is “Major studies decades ago revealed variability of menstrual cycles” (But people are still naïve about the basic cause of the difficulty to achieve pregnancy).

The NFP and FABM approaches to birth control have managed to avoid being nicknamed “the Vatican roulette” – unlike the rhythm/calendar method of Ogino and Knaus, the pioneers of the fertile and sterile periods who discovered the menstrual cycle.

However, without our Ovulona™ the NFP and other fertility awareness methods are not reliable and, despite the NFP popularity in numerous countries, they are not any more suitable for birth avoidance than “the Vatican roulette”. Without the definitive determination of the fertile days, they are not approved for avoiding conception, and tend to be utilized for aiding conception.

That’s because, in the proceptive use (promoting conception), the methods’ lack of reliability only translates into an extended time of trying to conceive rather than into an unwanted pregnancy. Only!

Fertility awareness tends to be utilized for aiding conception by “focused intercourse” because of the high prevalence of the difficulty to conceive. And the “focus” is about all that those methods do, which helps – even if at least half is misfocused, if you take my meaning, if you see what I mean. The probability of conception increases with focus on the fertile window of opportunity. That’s fundamental, too.

People have a hard time accepting that getting pregnant is not as easy as expected, when they finally decide to want a baby – usually way too late, and after her use of the Pill. The drug makes healthy young women in their best years to postpone family- baby-making, it damages their cervical S-crypts thus causing difficulty to conceive and, by encouraging promiscuous sex life, it has caused an enormous increase in the prevalence of sexually transmitted diseases that also lead to infertility. Not just a double whammy, a triple whammy on womankind.  Sad, sad, sad.

The underlying principle of the predicament of unfulfilled yearning for a baby is highlighted in the second half of the caption accompanying the Toyen painting just below – an image of futile waiting. (Highlight extracted as the briefest of summaries from https://biozhena.wordpress.com/2010/05/25/difficult-conception-tied-to-pregnancy-complications-addressed/.)

 

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

Advanced age of the would-be Mum works against her on account of the Mother Nature’s Probabilistic Rules and Regulations of Baby-Making: Good health and successful insemination probabilities are degraded whereupon the strict Natural Eugenicist [i.e. Mother Nature] suppresses the conceptus.

So that, most often, the hCG pregnancy marker does not even have a chance to be detected – after the nerve-wracking 2-week wait – by the not-so-young Mum-candidate’s HPT [Home Pregnancy Test].

Needless to say that, all the more the not-so-young motherhood aspirant needs to enhance the fourth element of the equation, the probability of correct timing of the hoping-for-baby sexual intercourse.

And all this because the young lady used the Pill during the years best suited for baby-making, and as a consequence she is not-so-young any more. It’s not nice to fool Mother Nature! Or with…

Therefore, I conclude this blog post by disputing the positive and admiring message in the concluding paragraph in the above-cited article “The Birth of The Pill”. They write: “Margaret Sanger dreamt of the idea of a birth control pill since she was a young woman. If she wasn’t confined to the boundaries of her time, she and McCormick could’ve researched and funded The Pill without the help of any male doctors or scientists. Unfortunately, the society that they lived in would not allow them to do so; they did go as far as they could. Many of their achievements go unnoticed, but both women were really the leading forces behind the development of The Pill.” QUOTE UNQUOTE.

Yes, indeed, Margaret Sanger and Katharine McCormick were the leading forces in the inception of chemical contraception. Driven by a social, political agenda (with “can do” in lieu of the needed biomedical insight), they imposed on women, and hence on humankind, a simple-minded solution “as simple as taking an aspirin”. But, then… the consequences … among them an enormous increase in the incidence of sexually transmitted infections, contributing to the epidemic of infertility.

And that’s only for openers, as the saying goes. Referring to https://biozhena.wordpress.com/2012/04/18/the-perils-of-ivf-of-arts-of-giving-birth-at-old-age-part-2/: Detrimental effects on the offspring and – via epigenetics – on the health of future generations. Iatrogenic medicine kicking Hippocrates where it hurts the most. Also, therefore, quite the opposite effects with respect to the eugenic vision of Mrs. Sanger. Ironic, isn’t it.