Archive for the ‘electronic’ Category

bioZhena venture

July 9, 2015

A 2017 update.

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. That is the first (reproductive management) front, opened along with providing a superior (meaning: 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.

Also unprecedented and important for public health is our way of monitoring 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 screening, and its affordability, should significantly improve on the Pap smear screening test.

Transforming Female Reproductive Health Management prt scr

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

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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:

Friendly Technology - with cervical ring & Ovulograph

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

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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 she likened to the cardiologists’ ECG recordings but with the important advantage of being affordably and routinely generated by patients at home.

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 short, we are answering the call and challenge to “Improve the methods and criteria to assess ovulatory dysfunction” (per R.S. Legro MD, 2013).

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.

Abstract of Am J Obstet Gynecol 2012, 207(5), 345–354

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 detection of pregnancy, whether intended or unintended, is automatic with the primary routine use of the home-use smart sensor.

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

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

Or

10-year projections:

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

FVS compared with MVS

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

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bioZhena’s pitch on EquityNet:

Women’s personal sex management for the Information Age.

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

Income from it will support further breakthrough applications.

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

We monitor the brain – sex organs feedback loop.

Nobody else does.

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

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

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

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

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

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

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

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HPG slide 4 screen shot from 5 slide show

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

– one of the materials provided in the EquityNet posting.

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Contra Nescience Contra Insouciance (SM 2015)

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

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Cervix uteri and seven or eight related things

February 7, 2012

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

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

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

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

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

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

bioZhena's Weblog

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

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

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

Cervix:

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

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

July 10, 2011

The other day I tweeted: July 6 1415 Jan #Hus was burnt at the stake in Konstanz DE for #heresy against #doctrines of #Catholic #Church http://t.co/lM1SlwF

So what, you think to yourself? Okay, sure, you and many others have other things to be concerned about – and who cares about a 15th century heretic? Well, maybe some of us do, and I might on this occasion talk some heresy myself. How ’bout that?

But first, let’s be clear about what heresy is, and what Jan Hus’ heretic speech was about, very briefly. This, in case you don’t read the Wikipedia article http://t.co/lM1SlwF about the medieval thinker, a Czech priest, philosopher, reformer, master and rector at Charles University in Prague, chaplain to the royal court, confessor to the queen,  a key predecessor to Luther and the Protestant movement of the 16th century. It was only some 150 years later that “in 1567 Pope Pius V canceled all grants of indulgences involving any fees or other financial transactions” [indulgence = remission before God of the temporal punishment due for a sin after its guilt has been forgiven].

Master Jan Hus Preaching At the Bethlehem Chapel by Alphonse Mucha, 1916

Master Jan Hus Preaching At the Bethlehem Chapel by Alphonse Mucha, 1916

The Czech king (“Good King Wenceslas” of the English Christmas carol fame) supported Hus preaching against indulgences and other such corruption of “the substance and spirit of the gospel“, but the church’s hierarchy, having declared war on Naples, needed vast revenues to fund the war effort… When the sales of indulgences continued, riots broke out in Prague. Three pro-Hus students were beheaded, and then buried to public acclaim in the Bethlehem Chapel. The hierarchy countered by excommunicating Hus (for the second time). The archbishop “interdicted” the city; that is, he deprived the people of al the spiritual resources of the church, a terrifying development in the middle ages.

This is citing from http://www.victorshepherd.on.ca/Heritage/Jan Hus.htm ; there too you can get the rest of the story about the General Council in Constance, which city was then in Switzerland, with Hus guaranteed a “safe conduct”.

You could see at http://dictionary.reference.com/browse/heresy that the dictionary defines heresy as (1) an opinion or doctrine at variance with the orthodox or accepted doctrine, especially of a church or religious system, and (2) as the maintaining of such an opinion or doctrine. In our time, reference could also be to other types of system or establishment.

More to the point of the Master Jan Hus anniversary, and for a scholarly treatise on the punishment that the medieval intellectual received from the then establishment, treat yourself to http://en.wikipedia.org/wiki/Death_by_burning .

Preparing the execution of Jan Hus

Preparing_the_execution_of_Jan_Hus --- Müller-Baden, Emanuel (Hrsg.): Bibliothek des allgemeinen und praktischen Wissens, Bd. 2. - Berlin, Leipzig, Wien, Stuttgart: Deutsche Verlaghaus Bong & Co, 1904.

For, now that I gave you a preamble, I’ll go into a bit of potentially or mildly heretical talk myself, in relation to cervical cancer (and other STDs, sexually transmitted diseases). It is not heresy to remind ourselves that the HPV vaccines do not cure cervical cancer nor do they prevent infection by all strains of HPV – but it could be heretical to discuss that there has been a grave concern among the public about adverse effects, injuries and even deaths in some young recipients of the vaccines.

And even more so to point out that behavior control (the personal health practices referred to below) is advisable in view of the fact that the cancer is associated with early start of sexual activity and with promiscuity. “It is well known that more than 90% of cases of anogenital warts are caused by HPV. HPV has been implicated in cancers of the cervix, vulva, vagina, penis, anus, and oropharynx. The virus is a necessary cause of cervical cancer. [Note that] as many as 24 million American adults–that is, 1 in 5–may be infected with HPV.”

Sadly, and dangerously for the health of all of us, the above-cited phrase about “It is well known” is misleading because it pertains only to medical people (not even to all of them) as opposed to the general population. “Knowledge about the relationship of HPV to cervical cancer is low even in the United States and the United Kingdom.” One of the sources, on which this assessment is based, concludes: Cervical cancer risk factor knowledge, especially knowledge about HPV is low, even among women with the history of cervical cancer. Younger and more educated women are more likely to have HPV and cervical cancer knowledge accuracy. The importance of personal health practices and the focus on health education should be equally emphasized to achieve successful cancer prevention through vaccination. [Emphasis mine.]

In May, @bioZhena tweeted some on this subject. –

@bioZhena:                                                                                               Can #cervicalcancer #screening be done #simply at home as part of a precise determination of #fertile days? http://to.ly/xEO #womenshealth

@bioZhena:                                                                                               Why is it important to do regular #cervicalcancer #screening – besides the fact that #Merck says so? #Gardasil Why the Ovulona? http://to.ly/xEO

RT @BelievnTomorrow Julie Hewett by @bioZhena:                        The Pope, Condoms and HPV: What Pope Benedict May Not Know #PreventCC #HPV http://ow.ly/4Vo4W

@bioZhena:                                                                                            #fem http://bit.ly/k7As90 GARDASIL does NOT prevent all of #cervical #cancer Merck says: It’s important to continue regular #cervicalcancer #screening

@bioZhena:                                                                                     #Gynecology experts divided http://to.ly/awuh whether deaths & blood clots serious but rare side effects of the #HPV #vaccine #Gardasil #fem

@bioZhena:                                                                                       #Gardasil unexplained death http://to.ly/aB9A Coroner raises questions about #HPV #vaccination ¬es 78 US deaths related to Gardasil (51 by CDC)

@bioZhena:                                                                                               The Truth About #Gardasil http://to.ly/awu9 by @mariangreene04 No known treatment to help these girls as they suffer in silence #womenshealth

@bioZhena:                                                                                                             http://to.ly/awun reports of injury, death related to #Gardasil #HPV #vaccine It prevents positive #Pap – not CC [Cervical Cancer] Think Ovulona http://to.ly/xEO  AND THINK ABOUT THE BOLD-FONT STATEMENT JUST ABOVE.

Alphonse Mucha: Madonna Of The Lillies

Alphonse Mucha: Madonna Of The Lilies

There then appeared a physician’s tweet “in defense of” the HPV vaccines, dismissive of the public concerns:

@DrJenGunter tweeted:                                                                              @bioZhena don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals

@DrJenGunter tweeted:                                                            @bioZhena all the US deaths post Gardisil have been investigated and no causal relationship identified. Several good publications.

@bioZhena responded with a request for the source of the info, i.e., for those “several good publications”.

@bioZhena:                                                                                              Thanx @DrJenGunter for your msg on #Gardasil #Cervarix safety. Would you share references? I got CDC http://to.ly/aB3v                8% VAERS were serious (defined) = 1,468.

@bioZhena:                                                                                @DrJenGunter #Gardasil http://to.ly/aB4c ~half the adverse reactions required a trip to the ER & about 20% of those girls “Did Not Recover”

@bioZhena:                                                                                                 RT @DrJenGunter: @bioZhena 2011 meta analysis in peer reviewed journal > 44,000 girls no increase in adverse events with Gardasil vs. control #vaxfax — Any chance that you’d share the 2011 meta analysis reference, please?

@bioZhena:                                                                                             #Gardasil Gardisil Silgard Re: @DrJenGunter 2 @bioZhena “don’t use media sources as references, there are excellent reviews of VAERS and Gardisil in real journals”. Please cite them disproving deaths, harm. Email:  vaclavkirsner@yahoo.com . I look forward to hearing from you. Hard data is indeed necessary.

Did not receive any, unfortunately.

Meanwhile, the government’s Centers for Disease Control and Prevention – in “Reports of Health Concerns Following HPV Vaccination” http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html – states, among other things (albeit not “in real journals”):

Blood Clots
There have been some reports of blood clots in females after receiving Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.
Deaths
As of February 14, 2011, there have been 51 VAERS reports of death among females who have received Gardasil. Thirty two of these reports have been confirmed and 19 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 32 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination. END QUOTE.

Whereupon @bioZhena suggests: The anti-Hippocrates harm does not go away, and cervical cancer screening is no less needed post-vaccination than without it. That’s why @bioZhena’s interest in the topic, as we propose to introduce a better screen than the Pap – but this requires some funding. With our screen done automatically by women at home (in the background of the primary use of the Ovulona™ monitor), the concern that the Pap frequency would suffer in the West is or can be answered, and providing the screen to the population in the non-West countries is a big plus.
Posted by: http://twitter.com/bioZhena   5/26/2011 12:48:52 AM from Twitzer

@bioZhena:                                                                                                  India halts #HPV #vaccine trial after 6 girls die, US does nothing – 67 deaths http://to.ly/aALf #Gardasil & #Cervarix #cervical #cancer

@bioZhena:                                                                                       #vaxfax #womenshealth Worth repeating: Vaccination does NOT replace routine #cervicalcancer screening – does NOT protect against all #HPV types http://to.ly/aB3v And: Vaccines do NOT cure cervical cancer

@bioZhena:                                                                                              #HPV #PreventCC even vaccinated must screen4CC [must screen for cervical cancer]: 20-30 yrs old screen every 2 yrs, 30-65 yrs every 3 yrs if Pap is normal http://to.ly/aGu3

RT @MedscapeOBGYN by @bioZhena:                                             Cervical Cancer Screening Every 3 Years for Most Women http://bit.ly/mhop42

@bioZhena:                                                                                              #Vaccination does not replace routine #cervicalcancer screening! Vaccines don’t protect against all #HPV types http://to.ly/aB3v & they don’t cure it

Alfons Mucha, Malířství

Alfons Mucha, Malířství

@bioZhena:                                                                                     Comment from http://to.ly/aCD3 #Cervical #cancer “smear tests are invasive uncomfortable embarrassing & often are badly diagnosed”. Hear hear!

@bioZhena:                                                                                                  Comment from http://to.ly/aCD3 “De-stigmatize #cervical #cancer and do some work to make test less unpleasant – more #women will go”. Hear hear!

@bioZhena:                                                                                       #womenshealth RT @BelievnTomorrow #HPV and #cervical #cancer – (We can do better!) http://ow.ly/506ha ->Easy home screening http://to.ly/weK

@bioZhena:                                                                                                e-tech #medtech 4 getting #women everywhere screened 4 early signs of #cervical #cancer http://to.ly/aGtS  Innocuous, affordable.

That’s it – we can do better than the Pap.

But does anyone hear this?

@bioZhena:                                                                                             What is the significance of the #HPV epidemic? http://to.ly/aB44 Already in 1842 a Verona #doctor observed: #cervicalcancer is due to sexual activity http://to.ly/aB46

#Women who get #STD screening can avoid #infertility caused by #STDs http://to.ly/aIyq  Future home screen http://to.ly/xEO http://yfrog.com/kfgl0dfj

@bioZhena:                                                                                              Here is a thought. Daughters of @BarackObama too will benefit from our #medtech #fertility #cervical #cancer screen. See about the Ovulona at http://to.ly/xEO

Is this a heresy?

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

December 8, 2010

Could high prevalence of prematurity be a consequence of motherhood not being the top job held by society in high esteem? A modern paradox.

December 5 is the eve of St. Nicholas Day, the patron Saint of many people, cities and countries – including the largest one [ http://en.wikipedia.org/wiki/Saint_Nicholas#Deeds_and_miracles_attributed_to_Saint_Nicholas ]. St. Nicholas is remembered and celebrated in similar ways in some countries, rewarding well-behaved children but not the misbehaving ones… Which is why St. Nicholas, known as Svaty Mikulas, visits the children at home, in certain parts of Central Europe, in the evening along with an Angel and a Devil (Cert). The Saint asks the parents about the kids’ conduct…

Josef Lada_Mikulas, andel a cert

Josef Lada - Mikulas doma

Josef Lada – Mikulas doma

I share with you a depiction of the tradition drawn by Josef Lada in the troubled 1930s, an idyllic tradition of an industrial people, which they keep to this day…

Besides numerous miracles, this most popular of Saints was and is reputed for gift-giving (hence the commercialized Santa Claus transformation morphing St. Nicholas  with a Western or Northern European Father Christmas later on in the month of December).

There are numerous legends about Saint Nicholas’ miracles and his deeds of help. Perhaps the most famous one is about the three daughters of an impoverished man who could not afford a proper dowry for them, dowry being an ancient habit, the original purpose of which “was to provide ‘seed money’ or property for the establishment of a new household” – and we are now talking about the 300s CE [Christian Era].

The saint Bishop of Myrna saved the girls from the fate of slavery and prostitution by secretly dropping “three purses (one for each daughter) filled with gold coins through the window opening into the man’s house”, which gift made the young girls “eligible” again. It is also said that he dropped the gift down the chimney where stockings were hanging “over the embers to dry, and that the bag of gold fell into the stocking”. That’s beside the point because we are not discussing Santa of Christmas, but rather we are remembering St. Nicolas of December 6.

Jan_Steen_Het_Sint_Nicolaasfeest, The Feast of St. Nicholas

Jan_Steen_Het_Sint_Nicolaasfeest,                               The Feast of St. Nicholas

In those times many, many centuries ago, the chief purpose of young women’s life was motherhood, naturally within a marriage, hence the said dowry habit. In our times, many things have changed, including, unfortunately, young women’s attitude towards motherhood. Well, not just young women’s attitude…

Motherhood must be held in high esteem to reverse the trend reflected by an outcry in tweeter-sphere that’s a part of life nowadays: “I never felt marginalized as a woman until I became a mother”. Now this is very sad. Sad for society since the opposite should be the case.

Motherhood is the most important “job” in the world, and this is not some cute old-fashioned thought. Women bear enormous responsibility for the health of the nation, of humankind. Society should pamper them. Meaning: Society should be organized based on the recognition of Mother Nature’s design, which design – with the optimal years for motherhood in the early twenties – does not go away only because nowadays we can do all kinds of things – including octuplet pregnancies at grandmotherly age.

One consequence of the referenced changes is the currently common delays in getting married, and especially delays in bringing children into the world, starting a family. In other words, the unfortunate consequence is motherhood in later years of life than Nature intended. And then there are other consequences. Among them, prematurity.

Lou Beach, Preggers

Lou Beach, Preggers

@DrJenGunter not too long ago tweeted on prematurity, the most common cause of infant morbidity and mortality in the U.S.: “I just wrote a book on prematurity. Personal and professional experience”. See The Preemie Primer: A Complete Guide for Parents of Premature Babies–from Birth through the Toddler Years and Beyond [Paperback], Jennifer Gunter MD (Author) at http://www.amazon.com/Preemie-Primer-Complete-Premature-Babies/dp/0738213934/

Here is a citation [from http://www.preemieprimer.com/ ]:

My son Victor has dystonic cerebral palsy. He weighed 843 g at birth and had a grade 2 IVH. The bleed resolved in the NICU without hydrocephalus.

He is seven years old now. He is very stiff and is so shaky on a bicycle that we have given up trying for now. He couldn’t stand on one foot until he was 5. It took a very long time for him to get the hang of swimming and at the age of seven he is by no means a fish, but I feel if he were to fall in a pool he could keep his head above water. His digestive tract is very affected, but we have figured out ways to minimize these issues. It took countless hours of OT and thousands of hours of him practicing, but his writing is beautiful and God know where he gets his spelling ability from. He hopscotches like a pro. He is reading a grade level ahead. All without a CT scan or an MRI.

Based on his exam and his problem areas I am sure his cerebellum is a mess. In fact, I wonder if I would have pushed him so hard if I had seen a brain scan before we left the NICU?

“What we know about prematurity” is reviewed by the March of Dimes Campaign at http://www.marchofdimes.com/Mission/prematurity_indepth.html .

Today more than 1,400 babies in the United States (1 in 8 [= 12.5%]) will be born prematurely. Many will be too small and too sick to go home. Instead, they face weeks or even months in the newborn intensive care unit (NICU). These babies face an increased risk of serious medical complications and death; however, most, eventually, will go home. … In fact, the rate of premature birth increased by more than 20 percent between 1990 and 2006. … The rate fell to 12.3 percent in 2008 from 12.7 in 2007, a small but statistically significant decrease.

Why women deliver early? In nearly 40 percent of premature births, the cause is unknown. However, researchers have made some progress in learning the causes of prematurity. Studies suggest that there may be four main routes leading to spontaneous premature labor.”

Štyrský, Marriage

Štyrský, Marriage

Do refer to the referenced article for more about the four main causes:

  1. Infections and/or inflammation.
  2. Maternal or fetal stress.
  3. Bleeding.
  4. Stretching.

And then there is this: These four routes are not the only things to consider. Other factors, such as multiple pregnancy, inductions and cesarean sections, can also play a role. (Mostly man-made factors, we note. I say “mostly” because some multiple pregnancies happen also to women who did not get pregnant through the Artificial Reproductive Technologies… )

Prematurity is bad for infant, parents, and public health. We at bioZhena propose to contribute to the reduction of its prevalence, by making the FOLLICULOGENESIS IN VIVO™ [FIV™] technology available for routine use by women and their physicians. As a particular example, in relation to the referenced other factors, we propose to make it possible to compute the Expected Date of Delivery (EDD) based on the expectant mothers’ folliculogenesis data.

The idea is to get away from the gestation calculation popularized about 200 years ago in 1812 by a Dr. Naegele, for whom the 40 weeks or 10 lunar months rule of obstetrics is named. This rule of 280-day gestation assumes that the mother ovulates on day 14 of a 28 day menstrual cycle, which the readers of bioZhena’s Weblog know that it is an unrealistic assumption.

America in 1812, the time of Dr. Naegele’s 200 years of fame

America in 1812, the time of Dr. Naegele’s 200 years of fame

Napoleon & carabiniers_in_front_of_Moscow_1812

Napoleon & carabiniers_in_front_of_Moscow_1812

Allegedly*, it was Dr. Hermanni Boerhaave, in his time a highly respected academic physician, botanist and chemist, who read in the Bible that pregnancy should last 10 lunar months. He is said to have formulated – in the 1700s – a way of calculating the expected date of delivery (EDD).

Thus, expectant mothers get EDD today based on the myth of the baroque-era Boerhaave … Yet, already Aristotle taught that “the human fetus is expelled … at any period of pregnancy …; moreover, when the birth takes place in the eighth month, it is possible for the infant to live.”

The gist of the bioZhena hypothesis is this: The EDD can be projected quite well from ultrasonic measurements of the unborn baby’s head and body size, but for a more convenient, affordable and consequently more practical solution, we propose to seek a correlation between the Ovulona FIV™ attributes such as cycle length and the EDD/EDC. Importantly, this will be done by using the date of insemination, which will be easily – electronically – recorded by the user of the Ovulona™ as an integral part of the routine.

Trying to be fair or considerate to the women’s healthcare classics, I report an obgyn.net paper at http://www.obgyn.net/fetal-monitoring/fetal-monitoring.asp?page=cotm/9807/cotm_9807 . It is titled “’Back to the Future’ for Hermaani Boerhaave, or, ‘A rational way to generate ultrasound scan charts for estimating the date of delivery’” by Dr David J R Hutchon, Consultant Obstetrician, Memorial Hospital, Darlington, England. This is about the ultrasound approach, and he comments that: QUOTE “the approach mimics, in modern terms, the method originally formulated by Boerhaave. … If Boerhaave had had an ultrasound scanner, his paper might have read something like, ‘It is proved by numerous observations that 99 out of 100 births occur 22 weeks (at 18 weeks gestation) after the biparietal diameter of the fetus is 40mm’ (Fig 1).”

Besides his Figure 1, I also share Mr Hutchon’s (a British medical doctor, when Consultant, becomes Mr again) Fig. 2, “Regression analysis showing line fit plot. The number of days between scan and delivery has been converted to conventional gestation by subtracting from 280. The lower and upper dotted lines represent delivery at 42 and 37 weeks respectively.” QUOTE UNQUOTE.

Gestation age vs. crown rump length by DJR Hutchon

Gestation age vs. crown rump length by DJR Hutchon

Gestation vs. biparietal diameter by Hutchon

Gestation vs. biparietal diameter by Hutchon

Biparietal diameter is the (outer – inner) measurement of the fetal skull echo. Crown-rump length (CRL) is the measurement of the length of human embryos and fetuses from the top of the head (crown) to the bottom of the buttocks (rump). In humans, the fetal stage of prenatal development starts at the beginning of the 11th week in gestational age, which is the 9th week after fertilization. These are the Wikipedia reported definitions. The two weeks between 9 and 11 assume the “regular” length of the menstrual cycle, which is a theoretical assumption that could very likely be incorrect in practice, in the given woman and in the given last cycle of hers (because regularity is a myth, too). Well, look at the scatter in the data points, it’s telling.

In addition to the convenience, affordability and practicality of the bioZhena approach, do not overlook the feature that the data will be personal to the given woman, and the measurement will not refer to LMP. It will not rely on the woman’s recollection of her last menstrual period (instead, it will refer to the last electronically recorded intercourse); and it will not subject the baby to unnecessary ultrasound radiation.

For more on the topic, try under Gestation in the Alphabet of bioZhena https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf (or https://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena/ ). See also the discussion under Parturition, where we express the expectation that parturition management will be revolutionized by the introduction of the Ovulona into obstetric and gynecological practice.

Anderle - Pasek 06

Anderle – Pasek 06

Summary Definitions [quoted from http://www.righthealth.com/topic/Fetal_Age ]:

Gestation is the period of time between conception and birth, during which the fetus grows and develops inside the mother’s womb.

Gestational age is the time measured from the first day of the woman’s last menstrual cycle [LMP] to the current date. It is measured in weeks. A normal pregnancy can range from 38 to 42 weeks.

Infants born before 37 weeks are considered premature. Infants born after 42 weeks are considered postmature. (Note: 42 x 7 = 294).

Especially with the challenged menstrual cycles that are particularly irregular in length, referencing the LMP in the reckoning can easily introduce a significant error. Perhaps that is why the above summary definition of normalcy is 38 to 42 weeks but prematurity is “before 37 weeks”? (A week here, a week there…) Read also the earlier post https://biozhena.wordpress.com/2008/01/11/about-the-edd-andor-edc-issue-and-a-request-for-input-from-readers/ .

Tomáš Císarovský  - Kukátko

Tomáš Císarovský – Kukátko

280 may have been in the Bible, but it ain’t necessarily right. We’ll see whether 266 is, and whether it is a worldwide constant, which is doubtful. If for no other reason, global constancy is doubtful because it was reported from India that “Mean gestational age at the onset of labour for women native to the area of study was 272 days (standard deviation 9 days). Pregnancies beyond a duration of 280 days showed significantly increased perinatal morbidity.” (Referencing the above righthealth.com definitions, we see 294 – 280 = 14. A week here, a couple of weeks there…)

Well, 272 – 14 = 258. Not 266, and that number is of interest because per Encyclopedia of Childhood and Adolescence, ”a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception” (article Gestation Period and Gestational Age).

And then you have the oprah.com article, which asks, “Will the labor start naturally on time, or will the baby be so late that induction or Caesarean section is necessary?”: http://www.oprah.com/relationships/Is-Pregnancy-Really-40-Weeks-Long . While debating the validity of the word “necessary” is not the point here, the author there refers to data from studies that concluded greater than 280 days due dates (288 days in one study), of which one study was in Sweden.

A hypothesis can be that hot climates may lead to lower gestation periods than cold climates. This would be a hypothesis based on two data points and a common sense for “the babies taking longer when it’s cold outside”… We’ll want to compare, say, data from Inuits and Lapps on the one hand with data from equatorial Africa and Philippines and/or Indonesia on the other. Logically, we’ll control for factors known or suspected as being involved, such as those four main causes listed above – and age, parity and other factors already explored by people such as Mittendorf in the 1980s.

Kupka - Creation de l homme

Kupka – Creation de l homme

The idea is that routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation, which is available to the women receiving IVF or artificial insemination. The data will be personal and the geography of the birth will be noted (as well as ethnicity), with data sooner or later coming from all corners of the world.

Capturing and working with the fertilization date should, by and of itself, be an improvement over the current way of EDD/EDC assessment. An improvement over the paradox of modern obstetrics and gynecology handling the most important aspect of reproduction by means of some biblical myth, and having become more and more interventionist probably at least in part because of that myth. Reference a recent tweet: Maternity Care In America Rife With Systematic Failures l Being #Pregnant http://su.pr/2j91wY “most people don’t know normal birth”. This refers to the medical staff.

That these thoughts are sensible, and that the chief problem is the LMP, is supported by ultrasound studies such as “Gestational age and induction of labour for prolonged pregnancy” by Jason Gardosi, Tracey Vanner, and Andy Francis (Perinatal Research, Audit and Monitoring, Department of Obstetrics and Gynaecology, Queen’s Medical Centre, Nottingham, UK) in British Journal of Obstetrics and Gynaecology, July 1997, Vol. 104, pp. 792-797 – [http://onlinelibrary.wiley.com/doi/10.1111/j.1471-0528.1997.tb12022.x/pdf].

Citing from this study of more than 24.5 thousand pregnancies: Menstrual dates [LMP data] systematically overestimated gestational age at term when compared with scan dates… suggesting that most pregnancies which are considered ‘prolonged’ according to menstrual dates are in fact mis-dated. The median gestational age for induced labours was 286 days by last menstrual period but only 280 days by scan, and most (71.5%) inductions done post-term (> 294 days) according to menstrual dates were not post-term if scan dates alone are used to calculate the gestational age.“

This study was a retrospective analysis of computer files of 24,675 pregnancies delivered in a teaching hospital between 1988 and 1995.

Here is their graphical summary of distribution of deliveries as a function of gestational ages by ultrasound scan dates.

Deliveries vs. gestational ages by ultrasound scan dates

Deliveries vs. gestational ages by ultrasound scan dates

Their most explicit statement in support of our conviction and plan is this citation: “Even if the date of the last menstrual period is recalled with accuracy, delay in ovulation can result in over-estimation of the true gestational age, which results in an apparent prolongation of pregnancy.” The authors also cite a 1972 paper in American Journal of Obstetric and Gynecology in support of the just cited statement.

The Gardosi et al. paper concluded: Regardless of obstetric and maternal views of the advantages and disadvantages of routine induction policies, our results suggest that most post-date inductions are unwarranted on the basis of gestational age. The incidence of prolonged pregnancies can be considerably reduced by establishing dates by ultrasound alone.

Needless to say, a similar graph for deliveries in India would show the spontaneous labor peak earlier (272 days by one study in tropical Manipal) while a Scandinavian graph would be shifted in the opposite direction; both were referenced above.

I’ll be darned if the introduction of the Ovulona into the gestation arena should not bring some order and peace (as opposed to the mess and anxieties of today). As I wrote in the conclusion of the related January 11, 2008 article: It is perfectly realistic a vision that, in future, an expectant mother’s EDD and/or EDC will be assessed based on her folliculogenesis (FIV™) data.

The EDD/EDC will be computed automatically and provided by her own Ovulona Smart Sensor™. And no Saint Nicholas miraculous assistance will be required by the future users – although we will not write here the same for bioZhena.

———

* I write “allegedly” because I spent many an hour looking for evidence of truth in this allegation, only to find the Dutch man an impressive medico-scientific mind and an impressive likeable character – but no evidence of the biblical dogma ascribed to him. As I write this note, I am going once more through the tedious but interesting Dr. Boerhaave’s “Academical lectures on the theory of physic” of AD 1744. The man’s fame and authority was such that “a Chinese mandarin, seeking advice, addressed his letter to ‘Boerhaave – Europe’, and it was delivered”. See http://books.google.com/books?id=QTUVAAAAQAAJ&printsec=frontcover&dq=Hermanni+Boerhaave+1744&source=bl&ots=NCeCN4gLdd&sig=SoUA_WS6iSkh2A8WpBX7S4o54Uw&hl=en&ei=ebP-TP2WBIX2tgO12-mvCw&sa=X&oi=book_result&ct=result&resnum=4&ved=0CB8Q6AEwAw#v=onepage&q&f=false

Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25

November 11, 2010

Early Pregnancy Loss is also known as #stillbirth or #miscarriage, or Early Embryonic Mortality (EEM), and the Ovulona™ is a tool of evidence-based personalized medicine.

After the optimum fertility age of the early twenties, achieving motherhood gets more difficult. It becomes even more essential than before to know your three fertile days, during which – and only during which – conception can occur.

The simple basic principle is: Fertility status detection must be easy and reliable. PLUS early pregnancy detection is really important, and it should be built-in, an integral part of the conception-aiding tool.

Why? Because:

1) early in pregnancy the conceived baby would be harmed by some of the medications taken by the woman, e.g. by a psychiatric medication with teratogenic effect (harmful to the fetus, causing a congenital disorder);

and 2) because of the annual 600,000 miscarriages – per CDC statistics – out of the 6 million US births, which means that at least some 10% of pregnancies are lost to early pregnancy loss (EPL), miscarriage, stillbirth.

Many EPLs go unnoticed. The EPL is a part of the TTC [Trying To Conceive] or subfertility/infertility problem. Our Ovulona monitor of FOLLICULOGENESIS IN VIVO™ is the prospective solution for managing the problem.

The Ovulona™ detects the 3 fertile days for conception, and it will also automatically detect pregnancy immediately upon conception. Similar to early pregnancy loss — its detection is the inverse of pregnancy detection, which both involve the follicular waves. Like this:

Follicular waves disappear = pregnancy detected

versus

waves reappear in early pregnancy =  early pregnancy loss detected.

Furthermore, the cyclic profile data captured by the Ovulona can be used by your healthcare provider to assess what is going on, and provide more effective help.

DIFFICULT USE OF EXISTING OPKs [Ovulation Prediction Kits] is shown in the following tweet by a @WannaBeMom: “1st month using opk. Do the lines usually start light and then get darker day by day or do they ever go back & forth b4 ovulation?”

Our electronic device will take the WannaBeMoms into a different world of baby-making. See  http://s755.photobucket.com/user/vaclavkirsner/library/Second%20album/Pregnancy%20and%20birth%20control%20how-to%20by%20bioZhena?sort=2&page=1 = a pictorial “Pregnancy and birth control how-to by bioZhena”.

Honey is Sweeter than Blood by Salavador Dali, 1941

Honey is Sweeter than Blood by Salavador Dali, 1941

For a woman in her 30s who’s had a miscarriage or even two or three, “any delay in attempting conception could further decrease the chances of a healthy baby”, says CNN reporting on a medical study, http://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ .

Study: Women who conceive within six months of miscarriage reduce risk of another.”

November 2016 review and meta-analysis (data on more than a million women): “With an Inter Pregnancy Interval of less than 6 months, the overall risk of further miscarriage and preterm delivery  were significantly reduced.”

These are fundamental principles.

And another principle, not brought up by the CNN or by the study itself, is that a tool for monitoring the early stage of pregnancy for EPL is most desirable. We’d say, mandatory. The Ovulona device monitors (or tracks the process of) folliculogenesis in vivo, which includes the follicular waves that occur after ovulation. The waves disappear upon conception because the reproductive system does not go into another menstrual cycle – it’s pregnant.

In case of EPL, Early Pregnancy Loss (miscarriage), the waves will come back. Early Pregnancy Loss, or Early Embryonic Mortality, is quite a common sad experience of many of us.

The essential point made here is that the woman’s and her physician’s decisions should be guided by the folliculogenesis cyclic profile (and/or its distortion due to distress of any kind). The woman and her doctor should not make decisions or pass recommendations working in the dark, and the data, on which any decision should be based, must be personal to the given patient.

That’s what the Ovulona from bioZhena is for. Personalized medicine. Evidence based medicine. Should you be new to this, https://biozhena.wordpress.com/about/ is an introduction.

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

Automatic pregnancy detection is inherent in the Folliculogenesis In Vivo™ cyclic profile (follicular waves disappear).

This is a screen shot of one of my narrated slides about “what’s going on here”, and you can view (and hear) the slide at https://biozhena.files.wordpress.com/2015/07/single-slide-unprecedented-wealth-of-info-narrated.pps.

Note specifically that: The follicular waves, which occur after ovulation [when the body prepares for the next menstrual cycle], cannot remain in place after fertilization succeeds and conception takes place [because the post-ovulation regime change is even more profound]. That is the principle of instant detection of pregnancy. As opposed to the waiting for the HPT [Home Pregnancy Test] result.

HCG or Human Chorionic Gonadotropin laboratory signature

HCG or Human Chorionic Gonadotropin laboratory signature of the biomarker – detected in a pregnant woman’s urine about 2 weeks into her pregnancy by a HPT home-use urine test – as a color change (into which color the HPT reduces the illustrated complex lab signature)

Should the conceptus [product of conception, early embryo] be lost to EEM, Early Embryonic Mortality (miscarriage), the follicular waves come back to be seen by the Ovulona. That’s the principle of early detection of the miscarriage, and of detecting the return of the non-pregnant condition.

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

Entre Les Trous De La Memoire by Appia

The Ovulona is intended to help people such as those writing in a forum as follows:

My partner and i started trying for a baby in jan And Concieved in the first month. Unfortunately in march at 8 weeks I had a miscarriage. We have been trying since with no luck. Could something be wrong. Please help this is really getting me down. http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=57881&f=5

We got pregnant the first cycle with both my ds and dd. I am most likely moving to cycle #11 with this baby. We did conceive on the second cycle of trying with baby #3 but we miscarried a week later. Nothing since then. I’m not sure why this time is taking so much longer. http://www.mothering.com/discussions/showthread.php?p=16029816

Can anyone advise? My daughter has been trying to get pregnant for several years. Her husband is fine. My daughter has now been asked to go for a scan which scared the life out of me (you automatically think something is horribly wrong). Can someone tell me what the scan is about – what sort of scan is it? http://www.netdoctor.co.uk/interactive/discussion/viewtopic.php?t=31528&f=5

The information contained in the folliculogenesis cyclic profile, as illustrated in the slide captured above, is meaningful and can help the healthcare provider to answer questions such as these.

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

March 28, 2010

And here is again why

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

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

That must be the main one for the TTC [Trying To Conceive] people, but additional attributes are no less significant. Multi-purpose applicability including but not limited to built-in early pregnancy detection and early pregnancy monitoring. That’s to help manage and deal with the inherently high prevalence of early embryonic mortality [EEM], the chief complication of human gestation. (See https://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection .)

When the TTC hurdle is successfully dealt with, the EEM is the next obstacle on the way to overcoming the sub-fertility issue. Just think about this for a moment. The EEM is Mother Nature’s design to deal with problems that quite likely lead to the TTC challenge (aka sub-fertility or even infertility) in the first place…

Pregnant

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

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

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

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

Book of hours - 069q

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

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

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

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

The existing commercial products cannot be used, either, for an attempt at baby gender pre-selection by timing conception with respect to ovulation. They cannot do that because they do not anticipate ovulation accurately and they do not detect ovulation (they merely assume its occurrence).

Miro - Birth World

Joan Miro – Birth World

Consequently, those techniques cannot distinguish between 2 or 3 days before and the day of ovulation. This is to try for a boy or for a girl, respectively, or to TTC, or to avoid conception. The commercially available technologies do not detect ovulation independently of the one predictive element they test for – or two such elements, LH and E2, in the case of the urine-analyzing gadget now sold by Inverness/SPD GmbH. It is not unlike groping in the dark… The other electronic gadget out there, the one offered by Zetek, is tracking indirectly the effect of the same hormone (estrogen) in two body fluids with two probes at two different times during the menstrual cycle. And your old BBT method tracks indirectly the effect of progesterone that you know causes the BBT to go up a bit after ovulation, albeit with a statistical uncertainty of + or – 3 days (and a poor signal to noise ratio at that).

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

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

Clock Explosion by Salvador Dali

Clock Explosion by Salvador Dali

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

There are also earlier posts about the variability of ovulation times from cycle to cycle in the same woman (as well as across a population), and the variability can be more than the width of the fertile window, more than the said 3 days. That 3 day span tends to also be the statistical uncertainty of the old techniques referenced here, plus or minus 3 days.

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

Ovulona prototype detects delayed ovulation

In the four recorded cycles of a childless 41-years old patient, the Ovulona prototype captured 3 delayed ovulations out of the 4 recorded cycles. In only one of the four cycles did the LH agree with our ovulation marker while Peak Mucus indication was one day late in that cycle. In the three cycles with delayed ovulation, the delays were:

In cycle 1:  4 days after LH kit positive and 3 days after Peak Mucus.

In cycle 3:  3 days after LH kit positive and 2 days after Peak Mucus.

In cycle 4:  1 day after LH kit positive and 2 days after Peak Mucus.

In another post in this blog, we showed how the test data divides the NFP clinic patients’ results into two categories that we termed regular and irregular (challenged). To avoid confusion with the traditional usage of the term regular/irregular in the context of menstrual cycles, we shall refer to the two categories as ordinary and challenged, respectively. Cycle 2 is an ordinary cycle (with LH and Peak mucus within 1 day of ovulation marker day) versus the other records showing challenged cycles with delayed ovulation.

The other challenged cycles from the study are tabulated below here, and you will note that they are quite numerous even in the small study of just 10 women with 2 cycle records each. Even in that small population of real life women, 45% cycles were challenged. You also see that the ovulation delays occur at any age (here from 19 to 41 years of age), and regardless of parity (that is, regardless of whether the woman has ever borne children or not):

Challenged menstrual cycles in 10 women

In the table of ovulation days indicated by the three techniques, O stands for the ovulation marker of Ovulona prototype, LH means LH kit (OPK) positive result, and Pk means Peak Mucus result (as taught by NFP teachers).

As noted above, LH and Pk are in all these cycles lower than the O values, which relationship defines the category of challenged cycles (ovulation delayed with respect to given hormone signal). The delays in this small sample from a small pilot study are from 2 days to 4 days with respect to LH, and from 2 to 3 days with respect to Pk; two cycles are without any LH surge detection.

We also note that our self-diagnostic process – while generating the detailed folliculogenesis profile data for optional analysis by the woman’s healthcare provider – is not unpleasant as is urine sampling, and is not cumbersome, confusing or prone to subjective misinterpretation of results as the other technologies tend to be.

We can and we do envisage the Ovulona to become a friendly routine for the women of the 21st century, everywhere. The existing home-use fertility monitoring products could not aspire to play that role. Hormones in body fluids are only of temporary utility for TTC. Against that, FIV (or Folliculogenesis In Vivo) is not only a superior tool for TTC but it goes beyond that first use – to be of unprecedented and unique service in personalized women’s healthcare for years to come.

See earlier posts in this blog about how symptoms (such as PMS symptoms) vary depending on the day of cycle and on the health conditions of any woman. It is known that female patients respond to therapy differently in relation to their menstrual cycle, i.e., in relation to folliculogenesis. That relationship to the FIV profile is THE fundamental guiding principle of personalized medicine for women.

A new era of obstetrics and gynecology in the offing.

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

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

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

        STOP PRESS

For more information go to the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Why people cannot achieve pregnancy

March 6, 2010

In many cases – if not most – it is NOT because of clinical infertility.

Basic cause of “apparent” infertility

This article is about the basic cause of most disappointed efforts at achieving pregnancy. The basic cause of the disappointment is that intercourse is had at a wrong time. That is, not during the kairos time of your menstrual cycle, the right time, during which – and only during which – fertilization can occur and result in conception (that may lead to successful pregnancy).

Note that we are not talking here about the relatively few cases of real clinical infertility that are caused by certain organic problems such as, say, blocked fallopian tubes or similar.

We are referring here to what is termed by experts (medically classified) as reduced fertility or sub-fertility. This refers to the predicament of people who cannot achieve pregnancy for too long. We would say that even this terminology is misleading but it is well established in OBGYN medicine, so let’s work with it.

Of course, “cannot achieve pregnancy for too long” is medically expressed more quantitatively by postulating the number of months during which the attempts to conceive a baby turn out to be fruitless, disappointing. (Do we need to add that, as a consequence, what is supposed to be a significant physio-pleasure then often becomes a chore, with the stress only exacerbating the painful disappointment and the actual problem?) Yes, stress enhances the problem.

30% of women or couples cannot conceive when desired

For many years, the number of months during which unprotected intercourse does not result in pregnancy (and is classified as sub-fertility/reduced fertility) was defined as up to 12 months. For 12 months of fruitless attempts to get pregnant you were sub-fertile, suffering reduced fertility. Only after a year, you became a case of clinical infertility.

More recently, as the prevalence of these problems increases, some medical authorities have extended this period of “advised patience” to as long as 2 years. Only after this extended period of advised patience in trying to conceive would the woman and/or couple be put into the clinically infertile category.

The basic cause of most failed efforts to become pregnant is simply wrong timing, wrong time within the menstrual cycle when the unprotected intercourse occurs with the intent to conceive a baby. This wrong time has much to do to with the continued belief, carried over from earlier times, that most menstrual cycles are “regular”. This is one of the myths. The exact opposite is true.

In fact, there is no such thing as cycle regularity. It is therefore essential to perform persistent monitoring, as the phrase goes nowadays, to determine the right time for a conceptive intercourse.

It was found decades ago that most women experience changes of even more than five days in the length of the menstrual cycle, and therefore also changes in the day of ovulation. This fact of life is basic to the predicament of finding it difficult to achieve pregnancy.

Fact:

Less than 1% of women would be found with no variation at all, even for short sequences of only a few menstrual cycles, and absolutely no-one would be regular in more than about five cycles. [Ref.: John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine 31 (No.8), Supplement, 742 – 747, 1986; also – and particularly – see refs. therein to the largest studies, i.e., to R.F. Vollman, “The menstrual cycle”, 1977, and A.E. Troelar et al., “Variation of the human menstrual cycle through reproductive life”, 1967.]

The research involved thousands of BBT [Basal Body Temperature] records obtained from correspondingly high number of women. The research was carried out when the hope was that the then new technology of the micro-computerized thermometer would provide the answer to the quest for a definitive tool for reproductive management. Well, it did not.

The BBT is not the answer, it cannot be. It’s not the solution because it is notoriously unreliable, whether micro-computerized or measured with an ordinary thermometer. Simply put, the BBT is affected by too many things, and it has been found to rise anywhere from 3 days before to 3 days after ovulation, despite the expected rise immediately after ovulation.

Comment:

The sympto-thermal method of NFP practice, also known as the Billings method, gets around the notorious lack of reliability of the BBT by having women perform certain anatomical observations “down there” and observations of the appearance of the fluid wiped off “down there”. Subjective as this enhancement is, in a review of a sufficient number of cycle records you would see that it is more likely the sympto- observations than the thermal measurements that, when lucky enough, are associated with recorded pregnancy-test positive. Basically, any of this helps the woman to stay focused, and the lack of accuracy is made up for by an as high frequency of intercourse as practical or desirable. Like shooting in the dark with an automatic weapon… (but then, if there is no target in the dark…)

I got off on this tangent, and should come back to the inherent variability of menstrual cycles and ovulation times in another post. To impress on you that this basic fact of life is particularly important when you are finding it difficult to get pregnant – probably because you are past the most fertile years, which are – or, rather, were – the early twenties of your life.

About the Added Bonus of Folliculogenesis Monitoring – Automatic Pregnancy Detection

January 10, 2010

.

It will really be advisable for women to use the Ovulona™ personal fertility monitor as advocated. Whether pregnancy is hoped for or pregnancy-avoidance is the purpose, diligent routine use of the Ovulona will bring benefits.

What benefits? Not only the correct scientific reckoning of the expected period of gestation (usually spoken of as the EDD or EDC) but also the subject of this article: The automatic immediate detection of pregnancy, which is built into the bioZhena process of menstrual cycle (folliculogenesis) monitoring.

See and hear about this in the narrated slide at https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps . Here is an image of the slide:

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

We expect that the personal cervix monitoring will be continued after conception has been detected – whether planned or unplanned – for the reason of watching out for or guarding against the possibility of early pregnancy loss (EPL).

Immediate detection

The detection of EPL is based on the understanding of the post-ovulation part of the menstrual cyclic profile signature. In the event of an EPL, the menstrual cyclic profile (which cannot physiologically continue after conception and/or implantation occurs) is logically expected to come back, alerting the woman to try getting pregnant again as soon as possible. This urgency is to reduce the probability of recurring spontaneous abortion as documented in medical literature.

As a 2010 study concluded: Women who conceive within six months of an initial miscarriage have the best reproductive outcomes and lowest complication rates in a subsequent pregnancy. You can read a CNN article about the British Medical Journal published study at http://www.cnn.com/2010/HEALTH/08/05/miscarriage.try.again.asap/ . We cite the original BMJ publication at the very end of this post.

“Ask Medical Doctor” [http://www.askmedicaldoctor.com ] is a web site that provides numerous examples where it follows that our Ovulona™ personal fertility device will be just what the customer needs. And her OBGYN, too.

As an example, here is a posted question (courtesy of @pregnancydoc tweet) [http://www.askmedicaldoctor.com/medical/doctor/index.php?xq=63935 ]:

“I quit the nuva ring at the end of november, and had a short cycle. I was only on it for a month. My husband an I are trying to conceive. Last week I had a blood pregnancy test, which was negative. As well as the week before. Now I’m almost a week late. I’ve also experienced a little bit of breast tenderness, stomach tenderness, and lower back pain. what’s up?”

Answer by Dr.Bhumika Aggarwal on Fri 08, Jan 2010 10:33pm:

“Hi, Yes you could be pregnant. The only way to know the confirmed cause is a clinical examination by an OBG specialist and if required an ultrasound examination. You could take a urine pregnancy test at home – that would only help a week after you have missed your periods. You should get a blood test for beta HCG levels which would confirm or rule out a pregnancy. This is confirmatory for pregnancy in cases where the urine pregnancy test kit is not helpful. It would be best to consult your doctor without any delay. Regards.”

Commenting on the Ovulona advantage

The above case is not unusual, including the fact that, after quitting hormonal contraception, the menstrual cycle(s) will tend to be short, out of whack. More to the point, however, is that, with the routinely used Ovulona, pregnancy will be detected immediately, by the disappearance of the follicular waves normally appearing in the luteal phase of the cycle [the days after ovulation], whether the cycle is short, long or what have you.

Where the physician talks about the urine and blood pregnancy testing is where it gets interesting. When Dr. B. A. writes, “that would only help a week after you have missed your periods”, with the Ovulona the detection will be immediate and, importantly, the Ovulona will make it possible to monitor the progress of the pregnancy. Where the doctor writes, “You should get a blood test”, that will no longer be the only option for the woman in the early days of uncertainty about her pregnancy status, or in the subsequent early stage of pregnancy.

The point is this: The hCG level in the blood shows the presence of the conceptus, and the immediate disappearance of the follicular waves is expected to show the presence of the conceptus before the hCG test can. The reason is that the hCG test requires a certain minimal level of the human Chorionic Gonadotropin (hCG) to be reached, and then the blood concentration peaks on the analytical instrument’s readout that the service lab will use.

This is how the pregnancy shows in the lab test for hCG:

Conceptus signature - small

Conceptus signature – small

Figure from Proc. Natl. Acad. Sci. U.S.A. 96 (6): 2678–81 (March 1999)

http://www.pnas.org/content/96/6/2678.figures-only or http://to.ly/OYI

See also http://en.wikipedia.org/wiki/Human_chorionic_gonadotropin, or http://www.webmd.com/baby/human-chorionic-gonadotropin-hcg .

“Once the fertilized egg implants, the developing placenta begins releasing hCG into your blood.” “hCG appears in the blood and urine of pregnant women as early as 10 days after conception” [http://www.nlm.nih.gov/medlineplus/ency/article/003510.htm ].

“In non-pregnant women, hCG levels are normally undetectable. During early pregnancy, the placenta produces hCG and its level in the blood doubles every two to four days” [http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109390.htm ].

Nothing is perfect, and “hCG kits can detect a wide and varying range of different hCG-related molecules in serum or urine samples” rather than just the one molecule they want to detect [http://www.hcglab.com/index.html ].

“The primary role of hCG in the maternal organism is to serve as a signal to the ovary to maintain the corpus luteum, which would regress if it were not rescued by hCG. … It appears that exponentially increasing amounts of hCG are required to prolong the functional lifespan of the corpus luteum, which explains why the corpus luteum survives early pregnancy but regresses during unfertilized menstrual cycles…” [Parry, S, Glob. libr. women’s med., (ISSN: 1756-2228) 2008 http://to.ly/P0z ]. Corpus luteum (yellow body) is defined as a yellow, progesterone-secreting, mass of cells that forms from an ovarian follicle after the release of a mature egg (i.e., ovulation), http://to.ly/P0B . It is what becomes of the follicle after ovulation.

How it works

Against that background, we bring up the following expected effect of conception on the folliculogenesis profile as it is tracked by the Ovulona and used by the woman at home. The data accumulated in the memory of the device will be available for use by her physician and the healthcare system.

Précis: When conception occurs, the normal folliculogenesis process changes due to the developing pregnancy (i.e., due to the conceptus). Conception can only occur upon ovulation, and when it does then the change happens – immediately. The follicular waves that normally occur after ovulation can no longer appear.

Upon conception, the maternal menstrual cycling is overruled, taken over, by the conceptus and the placenta. Conceptus is defined as the product of conception at any point between fertilization and birth. It includes the embryo or the fetus as well as the extra-embryonic membranes [http://to.ly/P0t , conceptus is from Latin, something conceived; see concept].

The disappearance of the follicular waves will be immediate, and easily detectable. Importantly, as with the monitoring of folliculogenesis for the purpose of either achieving or avoiding pregnancy, it will be presented to the woman at home in plain English as “pregnancy detected” on the display of her Ovulona device.

A very important (and unprecedented) additional advantage of our technique is that any loss of the pregnancy will also be detected in the process of continued routine monitoring during the pregnancy. This is advisable because many conceptions end in natural loss, i.e., the early death of the conceptus. E. g., “absence of TLX antigen recognition due to sharing of maternal-paternal TLX antigen profiles may not allow anti-TA1 activity and may lead to subsequent fetal rejection”, http://www.profelis.org/webpages-cn/lectures/reproductive_physiology_2.html (http://to.ly/P1S ).

Seriousness of the EPL problem

Between one quarter and one third of pregnancies may fail hours or days after implantation [  http://www.hcglab.com/hyperglycosylated.htm , citing Prenat. Diagn. 1998;18:1232–40 and J. Endocrinol. 2002; 172: 497-506]. But see also Further References, below, where the incidence is put at 75%+ of all attempts to conceive – the most common complication of human gestation.

In view of the fact that “treatment of women who present with cramping and spotting in the first trimester of pregnancy would be better guided by a sensitive and specific test that would reliably categorize prognoses for pregnancies”, it is worthwhile to speculate as follows. Since “progesterone appeared to be the single most specific biomarker for distinguishing viable from nonviable pregnancies” [Obst. Gynecol. 2000, Vol. 95, Issue 2, pp. 227-231, http://to.ly/P39 ], and in view of our sensor’s mode of operation (and the expected response to conception), we might even speculate that differentiating between viable and non-viable pregnancies might be attempted with our technique, too.

As throughout the whole text in this article, speculate is the key word.

Further References:

Efficiency and Bias in Studies of Early Pregnancy Loss, Clarice R. Weinberg, Irva Hertz-Picciotto, Donna D. Baird and Allen J. Wilcox, Epidemiology, Vol. 3, No. 1 (Jan., 1992), pp. 17-22, http://to.ly/P3s

Early Pregnancy Loss,  http://emedicine.medscape.com/article/260495-overview Note: Chief Editor is Lee P. Shulman, MD – one of bioZhena Corporation’s Board of Medical Advisors.

Excerpted:

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 is10-15%, 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

The gestational age at the time of the SAB can provide clues about the cause. For instance, nearly 70% of SABs in the first 12 weeks are due to chromosomal anomalies. However, losses due to antiphospholipid syndrome (APS) and cervical incompetence tend to occur after the first trimester. END QUOTE.

Medline ® Abstracts for References 3-5,7-9 of ‘Spontaneous abortion: Risk factors, etiology, clinical manifestations, and diagnostic evaluation’ http://to.ly/P4e

Citing from one abstract on the list: “Preterm death of the human conceptus is common.”

Conclusion of a 2003 paper from China: We demonstrated substantial EPL in the non-clinically pregnant cycles and a positive relation between EPL and subsequent fertility. EPL = Early Pregnancy Loss. The conception rate per cycle was 40% over the first 12 months.

Conclusion of a 2010 British Medical Journal paper from Scotland: Women who conceive within six months of an initial miscarriage have the best reproductive outcomes and lowest complication rates in a subsequent pregnancy.                          

See it at: http://www.bmj.com/content/341/bmj.c3967.full?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Bhattacharya&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT

About the EDD and/or EDC issue, and a request for input from readers

January 11, 2008

EDD stands for Estimated Date of Delivery, while EDC stands for Estimated Date of Confinement (the time of going to hospital for the delivery, “the lying-in of a woman in childbed“).

Seasonality of Google Searches Bears Out These Thoughts And Plans

August and July, October and/or September are the months of the season of most births in the U.S. And Mums-To-Be are rather anxious about the timing of the pregnancy-to-birthing process, gestation.

Just see how, well ahead of the upcoming birth time, the interest in the search term “gestation” peaks every year in April, give or take a month. You can see it at https://www.google.com/trends/explore?date=2004-12-31%202017-01-18&geo=US&q=gestation (search terms: United States, 12/31/04 – 1/18/17, All categories, Web Search). I’ll expand on the seasonality aspect below, after I share some thoughts and plans.

The bioZhena thinking, in one brief sentence, is this: Aim to replace stochastic with deterministic, which is the purpose of our eukairosicTM diagnostic tools. Then the E in EDD and EDC will stand for EXPECTED.

‘Expected’ based on a measured data based computation, as opposed to a subjective recall based physician’s guess. Because, as I say in the very last sentence at the end of this article: Your approaching EDD and EDC are not normalized/relative like those in the statistical graph …

The medical position on the current status of obstetrics can be characterized by the following two papers.

1) Theory of obstetrics: an epidemiologic framework for justifying medically indicated early delivery

[BMC Pregnancy Childbirth. 2007 Mar 28;7:4. Joseph KS, Perinatal Epidemiology Research Unit, Department of Obstetrics & Gynaecology, Dalhousie University, Halifax, Nova Scotia, Canada]

QUOTE: Modern obstetrics is faced with a serious paradox. Obstetric practice is becoming increasingly interventionist … Whereas … mortality declines exponentially with increasing gestational duration, temporal increases in medically indicated labour induction and cesarean delivery have resulted in rising rates of preterm birth and declining rates of post-term birth. … [This] provides a theoretical justification for medically indicated early delivery and reconciles the contemporary divide between obstetric theory and obstetric practice. END QUOTE.

And 2) A re-look at the duration of human pregnancy

[Singapore Med J. 2006 Dec;47(12):1044-8. Bhat RA and Kushtagi P, Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal, India]

QUOTE: The duration of human pregnancy is arbitrarily taken as 280 days (40 weeks). Foetuses are considered to be at high risk once pregnancy goes beyond the expected date of confinement. … Conclusion: Mean gestational age at the onset of labour for women native to the area of study was 272 days (standard deviation 9 days). Pregnancies beyond a duration of 280 days showed significantly increased perinatal morbidity. It is suggested that there is a need for determining the length of gestation and to compile gestation-wise incidence of … neonatal morbidity indicators for different populations. END QUOTE.

Related medical publications are here.

I will rely on the birthing specialist, Janelle Durham, to verbalize for you the status quo in this aspect of the homo sapiens experience – below. First,

Gestation Period, Gestational Age and OvulonaTM

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age ,

” a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception.”

The Ovulona device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse as a part of her record of the menstrual cyclic profile. In every cycle, whether pregnancy is planned or not. This must become a part of the routine. The information will be electronically recorded along with the daily or almost-daily measurement data inherent in the use of the Ovulona.

With that menstrual cycling history data, this intercourse-timing information will be available for optional use by the woman’s physician(s). And in due course (contingent on funding) the cervical ring transformation of the Ovulona will remove the need for daily insertion…

Therefore, the routine use of the Ovulona (and of the internally worn HaloTM cervical ring) will provide for an equivalent of the above-referenced 38-week (266 days) calculation available to the women receiving IVF or artificial insemination. This alone should be an improvement on the current way of EDD/EDC assessment. In this context, an investigation should be undertaken into the question of whether any inference can be drawn from the woman’s menstrual cycle history prior to the conceptive (baby-making) intercourse.

Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

Questions

Questions such as: What evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF or artificial insemination pregnancies, i.e. about their documented gestation periods? Does the 38 weeks projection work? Always? If not always, can anything be correlated with any deviation?

Has anyone looked at whether there may be an effect of geography in terms of hot vs. cold climate on gestation periods of natives? And perhaps even at whether a gestation-period difference may arise in data at a well-selected locale between winter and summer deliveries (of course only natural, not “medically indicated early deliveries”)?

The complicating effect of first versus subsequent pregnancy has already been noted, of course… That evidence exists for gestational length variability with ethnicity (or race) has been noted, too:

“122,415 nulliparous women with singleton live fetuses at the time of spontaneous labour, giving birth in the former North West Thames Health Region, London, UK. Results: The median gestational age at delivery was 39 weeks in Blacks and Asians and 40 weeks in white Europeans.” [International Journal of Epidemiology 2004, Volume 33, Number 1, pp. 107-113 ].

I am happy to observe that this outcome is not counter-intuitive (because women with ancestors in hot climates seem to tend to shorter gestational age at delivery than those who can be presumed to originate from colder climate conditions).

Conceivably, such a preliminary info, which I am after here, is not forthcoming — and we shall have to try and gather even these preliminary data in a systematic manner when the time comes, but no question asked, nothing learned… Public or private input would be appreciated. (I wrote this request here in 2008.)

Although focused on the very serious complication in pregnancy, A Balancing Act: Ideal Delivery Timing & Chronic Hypertension by Eva Martin, MD is an example of the kind of information that we will need when setting out to start the adaptation of our technology to the challenge of assessing and managing EDD/EDC. Retweeting her piece, I tweeted in April 2017: This is why when the monitoring will better assess EDD/EDC >abandon old Naegele rule.

Dr. Martin has a few videos online on the subject of due dates, and here is one of them (~2 minutes): How to Calculate Your Due Date After A.R.T. –  https://www.youtube.com/watch?v=G4OCSwxTEIg  (in a nutshell: Fertilization + 266 days [38 weeks] as we already noted above, with reference to the Encyclopedia of Childhood and Adolescence).

There in any case does seem to be some, perhaps fairly good, basis for this attempt at a preparation for an introduction of a tool for definitive assessment of EDD and EDC.

Due Dates Paper by Ms. Durham

According to the due dates paper by Janelle Durham, written for Certification with Birth Education in January, 2002 , QUOTE: “some women are aware of when they ovulate, either based on formal methods and record-keeping such as daily temperature checks, or on physical symptoms such as mild pain upon ovulation, or observation of changes in vaginal mucus. Many women know the dates when conception was possible, because they know the dates when they had intercourse during their most recent menstrual cycle.

Due dates can be calculated based on these dates, but many physicians prefer to calculate it from date of last menstrual period. They may only calculate from conception date if conception was medically managed and supervised through techniques such as artificial insemination.

Based on date of last normal menstrual period.

Due dates are typically calculated based upon the date the last menstrual period began, according to the mother’s report. Naegele’s rule assumes that ovulation occurred 14 days after LMP, which is only the case for women with 28 day cycles. Some caregivers will ask their patients for a history of menstrual cycles so that they can adjust this number, as appropriate, for cycles of different lengths or irregular cycles.

It’s also important to consider: recent use of oral contraceptives, and their possible effect on ovulation date; inaccurate memory about when the last period occurred, the possibility of interpreting post-conception ‘spotting’ as a light period, and unrecognized pregnancy losses. These issues all complicate due date prediction, and it’s estimated that nearly 25% of infants who would be classified as preterm birth on the basis of the last normal menstrual period are not preterm. (Cited in Health Canada)” END QUOTE.

At this point, let me translate the one brief sentence I wrote at the top into a less specialist language. Ms. Durham shows a statistical distribution of gestation periods applicable to any woman, and that is the approach I labeled stochastic, because of its statistical nature. I admit, the word is harking back to the days of my postgrad phys chem endeavors, which were mostly endeavours at the time. 🙂 We could also say, probabilistic – two syllables longer, though!

Gestational Age at Birth vs. Weeks since LMP

http://transitiontoparenthood.com/ttp/birthed/duedatespaper.htm

Janelle Durham, for Certification with Birth Education NW. January, 2002.

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Our Goal Your Comments

With our eurokairosicTM diagnostic tools, we generally aim to determine the right time, and in the case at hand we propose to provide for a much less fuzzy assessment of the EDD and EDC. After all, precedent exists in the A.R.T. arena, and prerequisites, too, to some extent at least.

In a nutshell: Let’s replace the LMP/Naegele-based approach with a hard data-based technique, applied to each and by each Mom individually.

Again, your comments on and/or answers to the questions above would be useful. Public or private input would be appreciated. [Private to: vaclav@biozhena.com please.]

In any case, for more on this topic see a related post published on December 8, 2010: Saint Nicholas Day, his legend, and our modern day’s prematurity, EDD calculation, gestational age, problem with LMP. We show there data from a study of more than 24.5 thousand pregnancies demonstrating that “most (71.5%) inductions done post-term (> 294 days) according to LMP dates were not post-term if ultrasound scan dates alone are used to calculate the gestational age.”

Vision

It is perfectly reasonable a vision that, in future, an expectant mother’s EDD and/or EDC will be assessed based on her folliculogenesis in vivo (FIV™) data which will include the electronic record of every sexual intercourse. The EDD/EDC will be computed automatically and provided by her own Ovulona Smart Sensor™.

So that, for example, a woman in and native to (or perhaps with ancestry from) a hot climate region might automatically obtain her EDD of 39 weeks when she electronically registers her day of intercourse on her Ovulona. Versus 40 weeks for a white European, consistent with the knowledge base noted above and assuming its validation.

No more uncertainties as in the LMP-based estimation. The bell-shape curve of distribution (such as the Janelle Durham graph above) will be replaced by personalized specifics.

Seasonality of EDC Searches on Google

On June 1, 2015 (at about the time of the year when, statistically, most American expectant mothers are about the last trimester away from their Estimated Date of Delivery and of Confinement) I add the following illustration. It appears to suggest why in May and June each year for the last 6 years there is always a noticeable increase in the viewing statistic of this blog post that you are reading. The interest is up.

Seasonality of Search Google Trends for search term “EDC” 2009 - 2015

See the image better as Single slide – Google Trends for EDC Search 2009 – 2015 e

Check the trend for yourself by moving from the screen shot image to the actual graph online via the link http://v.gd/c2MOyR i.e. http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2078m&cmpt=q&tz= . Once online, the Google graph shows (with cursor put on data for different months) the counts of US searches for EDC in the different months. You can change the range of the time period via the Time button, and the country of interest via the Country button. The numbers represent search interest relative to the highest point on the chart. At the time of writing this, it was the number of searches in June 2014 (assigned the maximal relative value of 100).

Move the cursor along the graph to see the values for other months within the examined period. You’ll see the EDC value of 100 in June 2014; in June 2013 the US peak was at 72 counts. The worldwide trend is much like the US trend because the statistics are driven by the overwhelming majority of American searches. E.g. the May 2015 count worldwide is only higher by 7 more searches than the US value of 48; in June 2014 the worldwide count was the same 100 as the US while in June 2013 the worldwide count was 20 counts higher than the US count of 65.

That’s as of June 3, 2015. Might this change later? Well, click http://www.google.com/trends/explore#cat=0-45&q=edc&geo=US&date=1%2F2009%2082m&cmpt=q&tz=Etc%2FGMT%2B6 and see the graph as of September 12, 2015, which does show the June 2015 peak indubitably.

The worldwide count can be obtained via the Country button on the Explore bar in Google Trends (USA was selected here). The data are normalized, relative numbers – you can read up on it… It’s a Google algorithm.

And here now is a January 6, 2017 update of the Google Trends EDC results, showing that the June peak (in search activity for EDC) continues to be there; in June 2016 it stood at 88 while in June 2015 it was 89, as found by placing the cursor on the peak in the online graph (only one data point can be screen-printed as in the image here) – the URL is below the image:

google-trends-edc-12-31-08-to-12-31-16

https://www.google.com/trends/explore?cat=45&date=2008-12-31%202016-12-31&geo=US&q=edc

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Dear Reader,

Your approaching EDD and EDC – if indeed their coming up is the reason why you are reading this – are not normalized or relative values like those in the statistical graph

— and good luck, all the best from bioZhena!

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Parturition means birthing (birth) and dystocia a difficult one

January 9, 2008

And what is a parturition alarm?

For these and other entries, see the Alphabet of bioZhena at

https://biozhena.wordpress.com/2007/11/28/the-alphabet-of-biozhena/

Parturition alarm:

This is a concept that has to do with the need to know when labor or delivery is beginning, because the birthing female may be in need of help.

At the time of writing the first Alphabet draft more than five years ago, an Internet search produced only one such technology, a pressure-sensing girth, suitable for the horse breeder only, because it utilizes the fact that the horse mare lies on her side only in the process of parturition. To illustrate, we borrow a nice picture from a more recent publication found in today’s search on parturition alarm, which search still shows a preponderance of equine innovations:

Equine birth alarm

In the originally noted publication, reference was made to some other method that would detect the emergence of the amniotic sac or of the foal from the vulva (vaginal orifice) but that was not a satisfactory solution. In the horse-breeding arena, about 5-6% of births require help. Various approaches to the birth alarm solution have been attempted.

These days, there are quite a few patents etc. found in the parturition alarm search. And even 5 years ago, a patent from New Mexico University should have been found because their intra-vaginal parturition alarm patent (basically for cows) was published in 1987.

In human obstetrics, where most births take place in hospitals, determining the right time of confinement would be very beneficial. bioZhena (and/or its sister company, bioPecus) will investigate our vaginal sensor technology – suitably modified – with a view to developing a parturition alarm applicable to any mammal.

Also relevant in this context is the implication of the Ovulona making available the menstrual cycle (folliculogenesis) data over many months or cycles before conception. This will enable a more accurate anticipation of the EDD, Expected Date of Delivery. You will understand this better below, under Parturition. I highly recommend that you check out Figuring Your Due Date, too – from the Midwife Archives.

Let us put it this way: Since this is the bioZhena blog (and not bioPecus, for veterinary tools), the EDD issue must be addressed first, before any parturition alarm developments. Because we are primarily concerned with the Rerum Naturare Feminina.

And it would still be of great interest to hear from an expert Latinist about the correct way of saying this in plural, the Natural Thing of Women, the Women’s Natural Thing…

This being a reference to /2007/12/16/cervix-uteri-and-seven-or-eight-related-things/ .

Parturition:

The process of giving birth; childbirth. [From Late Latin parturitio, from Latin parturitus, past participle of parturire, to be in labor.]

Parturition is illustrated at http://www.mhhe.com/biosci/esp/2001_saladin/folder_structure/re/m2/s5/ .

The illustration’s legend indicates that physicians usually calculate the gestation period (length of the pregnancy) as 280 days: 40 weeks or 10 lunar months from the last menstrual period (LMP) to the date of confinement, which is the estimated date of delivery of the infant [EDD].

Indubitably, due dates are a little-understood concept:

“Truth is, even if you know the exact date when you ovulated, you still can only estimate the baby’s unique gestational cycle to about plus or minus two weeks” [ http://www.gentlebirth.org/archives/dueDates.html ]. Why should that be? Because of the variability of your menstrual cycle lengths? (They vary even if you do not think so).

Statistically, the gestation time for human babies has a mean of 278 days and a standard deviation of 12 days, an uncomfortably large spread. The old Naegele Rule of a 40-week pregnancy was invented by a Bible-inspired botanist Harmanni Boerhaave in 1744 and later promoted by Franz Naegele in 1812. It is still believed to work fairly well as a rule of thumb for many pregnancies. However, the rule of thumb also suggests: “If your menstrual cycles are about 28 days, quite regular, and this is not your first child, your physician’s dating is probably fine. If your cycles are longer or irregular, or if this is your first child, the due date your physician has given you may be off, setting you up for all kinds of problems” (induction, interventions, C-section among them).

This is where the bioZhena technology can be expected to provide help, making it possible to reckon the EDD with recorded menstrual cycle (folliculogenesis history) data rather than merely with the LMP + 280 days. This, once properly researched, may be expected to have a significant impact on obstetric management. — Any comments?

It is ironic that, in this age of technological medicine, American women worry about their birthing process not being allowed to take its own natural course on account of an ancient method of predicting the EDD.

Ironically, the 40 week dogma – which is the gestational counterpart of the unacceptable calendar method of birth control (the so-called “Vatican roulette”) – does not reconcile the 295+ days of the 10 lunar months; and yet, at the same time, the U.S. has an unusually high perinatal death rate, resulting from high statistics of too early (preterm) labor. Quid agitur? See also under Gestation.

Dystocia or birthing difficulty:

Dystocia is difficult delivery, difficult parturition. From Latin dys-, bad, from Greek dus-, ill, hard + Greek tokos, delivery. Calf losses at birth result in a major reduction in the net calf crop. Data show that 60% of these losses are due to dystocia (defined as delayed and difficult birth) and at least 50% of these calf deaths could be prevented by timely obstetrical assistance. The USDA web site http://larrl.ars.usda.gov/physiology_history.htm is apparently no longer there but when it was it indicated that an electronic calving monitor was being developed to determine maternal and fetal stress during calving. These studies are important since they are leading the way for developing methods to reduce the $800 million calf and cow loss that occurs each year at calving in the USA’s beef herds.

In analogy with the superiority of in vivo monitoring of folliculogenesis versus tracking behavioral estrus (heat), in vivo monitoring of the progress towards parturition must be a priori a more promising approach.

The telemetric version of the BioMeter – the animal version of the Ovulona technology – will hopefully provide a tool for these efforts. Once tested on animals, human use will be a logical extension of the endeavor. (Or endeavour, should it take place in Europe! Smiley…)

Comment about the EDD and/or EDC issue, and request for input:

Again, EDD stands for Estimated Day of Delivery, while EDC stands for Estimated Day of Confinement.

Per Encyclopedia of Childhood and Adolescence, article Gestation Period and Gestational Age [ http://findarticles.com/p/articles/mi_g2602/is_0002/ai_2602000272 ], ” a gestation period of thirty-eight weeks (266 days) is calculated for women who are pregnant by a procedure such as in vitro fertilization or artificial insemination that allows them to know their exact date of conception.”

The Ovulona device from bioZhena will provide to the woman user a very simple means to record the day of any intercourse. In every cycle, whether pregnancy is planned or not. This must become a part of the routine. The information will be electronically recorded along with the daily or almost-daily measurement data inherent in the use of the Ovulona. With that menstrual cycling history data, this intercourse-timing information will be available for optional use by the woman’s physician(s).

Therefore, the routine use of the Ovulona will provide for an equivalent of the above-referenced 38-week (266 days) calculation available to the women receiving IVF or artificial insemination.

This alone should be an improvement on the current way of EDD/EDC assessment.

In addition, an investigation should be undertaken into the question of whether any inference can be drawn from the woman’s menstrual cycle history prior to the conceptive intercourse. Any comments on this would be welcome, even about anecdotal or subjective or tentative observations that may be available already. However non-scientific, however tentative, however uncertain an individual answer or input from you may be…

E.g., do women with more or less regular cycles tend to exhibit a regular gestation period, and vice versa?

And, certainly, what evidence is available in medical literature (or maybe in unpublished records?) about the outcomes of the IVF and/or artificial insemination pregnancies, i.e., about their documented gestation periods? Does the 38 weeks projection work? Always? If not always, can anything be correlated with any deviation?

Do women with distinctly irregular menstrual cycles tend to have non-regular gestation periods?

The complicating effect of first versus subsequent pregnancy has already been noted, of course…

Conceivably, there is no such preliminary info available, and we shall have to try and gather even these preliminary data in a systematic manner, but – no question asked, nothing learned… Public or private input would be appreciated.


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