Archive for the ‘diagnosis’ 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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bioZhena & Women’s Fertility Watch(ing)

March 3, 2015

bioZhena & Women’s Fertility Watch(ing)

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

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

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

Lovers (Mr. and Mrs. Hembus) - Kirchner

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

Why screen for cervical cancer (and for the other STIs, sexually transmitted infections)?

July 29, 2011

Why all women need to screen for cervical tissue health, whether or not they accept that Nature is powerful (only  virgins don’t need to)

I will tell you why screening for this sexually transmitted infection (STI) is much needed, if you promise that you will not shoot the messenger. Exaggerating? Not really, if or when you realize that chances are that you yourself are already infected.

Is it so serious?

I say that because “current evidence suggests that at least 50 percent of sexually active women have been infected with one or more types of HPV”. Most people with HPV have no symptoms. When the infection is present, symptoms may or may not include genital warts.

HPV stands for Human Papilloma Virus. That is the virus that causes cervical cancer, and goes slowly about it, which is both good and bad. Good because the disease can be treated before it kills, and bad because it may take so long before it raises its ugly head that it can come completely unexpected in the mature middle age and even later. That is why vigilance (meaning, screening for it) throughout one’s lifetime is well worth it – unless you are a fatalist.

Collage of drevoryt woodcuts Dekameron, Ceský dekameron, Bakchanálie by Zdenek Mézl 1980

Collage of drevoryt woodcuts Dekameron, Ceský dekameron, Bakchanálie by Zdenek Mézl 1980     Links:      http://www.ikup.cz/item.php?id=600279&lan=EN        http://www.galerieart.cz/mezl_cesky_dekameron_I.JPG              http://www.galerieart.cz/prodej_mezl_staroveke_baje.htm

“Furthermore, the potential risk of infection from non-penetrative sexual contact remains undetermined, including the possible association between oral-penile contact and oral HPV, which is associated with oral cancer.” You can read this online in the peer-reviewed scientific publication Am. J. Epidemiol. (2003) 157(3): 218226. The experts give a reference (ref. 3) for the 50%+ statistic, and elsewhere the Medical Institute for Sexual Health writes http://www.medinstitute.org/public/92.cfm  : “About half of all sexually active 18- to 22-year-old women are infected with it (ref. 10 = J Infect Dis. 2001;183(11):1554-1564)”.

Either way, let’s watch out for the killer disease, which fortunately is curable – if caught early. If not caught early (that is, if not detected, diagnosed and treated), The Ravisher wins.

Cervical cancer causes about the same number of deaths as HIV/AIDS every year [two references for this statement are cited in the above Medical Institute article http://www.medinstitute.org/public/92.cfm ].

Young Woman Attacked By Death (or The Ravisher) - Albrecht Durer

Young Woman Attacked By Death (or The Ravisher) – Albrecht Durer

Get this! The most common STI. Both young and mature women in danger

Get this: The human papilloma virus (HPV) is the most common sexually transmitted infection (STI) in the world, and it is the most important cause of cervical cancer, a major killer of women worldwide (the second biggest).

Another horrible statistic is that, according to a CDC study, one in four (26 percent) young women, girls between the ages of 14 and 19 in the United States – or 3.2 million teenage girls – are now infected with at least one of the most common sexually transmitted diseases. Those are human papillomavirus (HPV), chlamydia, herpes simplex virus, and trichomoniasis. See http://www.sciencedaily.com/releases/2008/03/080312084645.htm .

A bad news for the mature women, who are past their best years for birthing, is this: “Cervical cancer is the second leading cause of cancer deaths among women worldwide. Human papillomavirus (HPV) has been shown to be the precursor of cervical cancer in over 99% of the cases. … Although women aged 40 and above are not specifically considered high risk for HPV infection, many women are testing positive in this age group and are facing the impact of an HPV diagnosis that implicates a sexually transmitted disease and is known to be a precursor to cervical cancer.” So is written in J Am Acad Nurse Pract. 2010 Feb; 22(2):92-100, in a paper titled “The human papillomavirus in women over 40: implications for practice and recommendations for screening”.

The Plague by Arnold Böcklin, 1898

Arnold Böcklin, The Plague, 1898

Pap smear test. Important. But problematic

While the Pap smear diagnostic screening has significantly improved the situation over the many years since its introduction (first published by the inventor, Dr. Georgios Nicholas Papanikolaou late in the decade of “the swinging 1920s” but only recognized in the 1940s), at least 12,000 women are diagnosed with cervical cancer each year in the United States, accounting for at least 4,000 deaths. Statistics cited from J Sch Nurs. 2007 Dec; 23(6):310-4.

As commented in June 2011 at http://to.ly/aCD3 (http://www.telegraph.co.uk/news/health/news/8554793/Women-making-excuses-to-avoid-cervical-cancer-smear-tests.html ), #Cervical #cancer “smear tests are invasive, uncomfortable, embarrassing, and often are badly diagnosed”. Another reader concluded: “De-stigmatize cervical  cancer and do some work to make the test less unpleasant – more #women will go” (will go to get the expensive test at a clinic, hoping for a negative result – and for not getting an unexpected huge bill, whether insured or uninsured in the U.S.).

Additional to the advantage of an objective electronic test over the subjective evaluation of a Pap smear: Is there a better way to avoid stigmatization than testing for cervical health in the privacy of one’s home, and in so doing making the test incomparably less off-putting, painless and perfectly affordable for anyone?

Similar to what the Pap smear can do, our tissue biosensing technique should detect the pre-cancerous tissue aberration called squamous intraepithelial lesion (SIL) or dysplasia, which is the earliest form of pre-cancerous lesion recognizable by a pathologist. Refer to http://en.wikipedia.org/wiki/Carcinoma_in_situ .

Unlike the pathologist’s subjective assessment of the Pap smear sample, our in vivo monitoring method provides for an objective electronic evaluation.

In countries like India, the cervical cancer prevalence statistics are much worse, an order of magnitude higher. A big problem is that, among the general population, “knowledge about the relationship of HPV to cervical cancer is low even in the United States and the United Kingdom”. [Rapose A., Human papillomavirus and genital cancer. Indian J Dermatol Venereol Leprol 2009;75:236-44.] So therefore, we are trying to do something about that.

Screening is really necessary. Here is why

There are two main reasons why screening for cervical cancer is and will continue to be necessary.

1. One is that the recently introduced HPV vaccines are far from perfect, and they explicitly require continued screening. Even the most expert proponents of HPV vaccination, and not just the vaccine manufacturers, say and write that.

Antonín Procházka, Milenci s knihou, litografie/lithograph, 1941

Antonín Procházka, Milenci s knihou, litografie/lithograph, 1941

2. Then there is the other reason for the necessity of continued cervical cancer vigilance. It is that, contrary to the oft trumpeted exclamations, the classic “invention of a certain doctor Condom” does not make for safe sex, because it (the condom) only reduces, and certainly does not eliminate, not only the chances of becoming pregnant but also the chances of contracting a sexually transmitted infection. These are medico-scientifically proven facts.

The condom and similar barriers do not completely and reliably eliminate the chances of pregnancy if you happen to have sex during the mere three fertile days of your menstrual cycle (when you are outside of the fertile window, pregnancy simply cannot occur). And, condoms and similar barriers do not completely eliminate – they only reduce – the chances of contracting sexually transmitted infections including HPV.

Sources, evidence – cervix is vulnerable

For sources of this statement of fact, see for example the already referenced http://www.medinstitute.org/public/92.cfm : “Each year, there are about 19 million new infections; half of these are in people under 25 (ref. 2). Many of these STIs have no cure. Untreated STIs can cause infertility, cancer and even death.” In that article is also where you see the references for the statements that “If you use condoms every time you have vaginal sex, you can cut your chance of getting HPV by up to half (references 6,7,8,9)… In women, cervical cancer causes about the same number of deaths as HIV/AIDS every year (refs. 12,13).”

Note this: Evidence shows that HPV is contracted if sex is had at too early an age and/or if sex is had promiscuously as a one night stand entertainment, or even too early into a relationship.

The cervix is particularly vulnerable to infection between the first menstruation and the age of sixteen because there are still many undifferentiated cells at the surface of the cervix, which is therefore  susceptible to HPV infection [http://www.mendeley.com/research/early-first-intercourse-risk-factor-cervical-cancer/]. As cancer is a disease of failure of regulation of tissue growth, HPV causes these cells to transform into cancer cells by altering the genes which regulate cell growth and differentiation.

Edgar Degas - Young Spartans Exercising, circa 1860

Edgar Degas – Young Spartans Exercising, circa 1860

An interesting story associated with the Degas painting includes “that the work could encompass a variety of meanings”, and that the fully dressed onlookers in the background are the youths’ mothers with Lycurgus, the legendary lawgiver of Sparta, who established the military-oriented reformation of Spartan society in accordance with the Oracle of Apollo at Delphi.

Reflecting on research findings

This blog post is not some exercise in moralizing. I am merely reporting or reflecting on medico-scientific findings. The above-referenced epidemiologists, Winer et al. [Am J Epidemiol 2003;157:218-26], evaluated young college women in Washington State and found that the risk factors for acquiring a new HPV infection included:

  • sex with a new person in the previous 5-8 months,
  • smoking, and
  • use of oral contraceptives.
  • Always using condoms did not provide protection according to this study.

The experts concluded that “in this population of female university students, the risk of infection associated with new partner acquisition is independent of prior sexual experience”, and that a “…finding suggests that an increased risk of incident HPV infection is more strongly associated with sex with a new partner than with sex with ongoing partners.” Thus written.

Peter Paul Rubens - The Union of Earth and Water, c. 1618

Peter Paul Rubens – The Union of Earth and Water, c. 1618                                  For the sake of appropriate symbolism, her name should be Aphrodite or Venus, of course, the promiscuous  goddess of love, beauty and sexuality!

The authors wrote (and here we cite selected notions to reinforce the mentioned ones).

QUOTE:

  • We detected a significant association between current smoking and incident HPV infection…
  • We also observed a significant association between current oral contraceptive use and incident HPV infection.
  • Having known a new partner for less than 8 months before vaginal intercourse was associated with an increased risk of HPV infection.
  • Reporting a new sex partner who has had one or more or an unknown number of prior female sex partners was also a significant predictor of incident HPV infection.
  • [Data] seems to suggest that the better and longer a woman knows her partner before intercourse, the less her risk of becoming infected with HPV.
  • Consistent with previous studies (4, 7, 11, 17, 29, 30), we observed no protective effect associated with condom use. … Since HPV is transmitted presumably through skin-to-skin contact, condoms may not protect against HPV because the virus can be transmitted through non-penetrative sexual contact.
  • Although vaginal intercourse is clearly the predominant mode of genital HPV transmission … any type of non-penetrative sexual contact was associated with an increased risk of HPV infection in virgins.
  • At 24 months, the cumulative incidence of first-time infection was 32.3%… [FYI: That’s 32% of the 603 young women studied between September 1990 and September 1997 by interview and a standardized pelvic examination every 4 months, including HPV DNA analysis from separate cervical and vulvovaginal swab specimens.]
  • Smoking, oral contraceptive use, and report of a new male sex partner –in particular, one known for less than 8 months before sex occurred or one reporting other partners– were predictive of incident infection. Always using male condoms with a new partner was not protective.
  • The data show that the incidence of HPV associated with acquisition of a new sex partner is high and that non-penetrative sexual contact is a plausible route of transmission in virgins.
  • HPV infections are highly prevalent, and current evidence suggests that at least 50 percent of sexually active women have been infected with one or more types (3).

In conclusion, the present study showed that the incidence of genital HPV associated with acquisition of a new sex partner is high, and that risk of infection is especially high if a partner has been known for less than 8 months and if a partner reports having had sex with other partners.

END OF QUOTES

[from Winer et al., that’s Rachel L. Winer, Shu-Kuang Lee, James P. Hughes, Diane E. Adam, Nancy B. Kiviat and Laura A. Koutsky, in Am J Epidemiol 2003;157:218-26, “Genital Human Papillomavirus Infection: Incidence and Risk Factors in a Cohort of Female University Students”. Let’s also reference http://www.google.com/search?q=Koutsky+LA%2C+Kiviat+NB.+Human+papillomavirus+infections.+In%3A+Holmes+KK%2C+Mardh+PA%2C+Sparling+PF%2C+et+al%2C+eds.+Sexually+transmitted+diseases.+3rd+ed.+New+York%2C+NY%3A+McGraw-Hill%2C+1999%3A347%E2%80%9360.+&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a].

Conclusion: Nature is powerful. Nature regulates

My conclusion for you is no preaching but an observation that all this is because Nature is powerful. As simple as that.

In terms of a clarification, or rather a rationalization of the reported findings, since you have an inkling about tissue rejection problems in organ transplantation (you’ve heard about that, haven’t you), I can draw a parallel for you. Think of the meeting of the male and female flesh as a short-lived tissue implant. If the two tissues don’t know each other, if the female has not known the male for sufficiently long, there is a natural reaction, which the cited experts have found manifested as HPV infection (a hint at how that happens: a stranger’s DNA attacks the recipient).

And what’s all this about that Nature is powerful? Well, it is simply to keep in mind that there are some natural laws and principles, such as the one about action and reaction. And, it’s about that Nature regulates

So, there will be a reaction to too much of a good thing (or a bad thing, any thing). I don’t want to get into this too much except to recall that, since the sexual revolution of the 1960s, there has been an enormous increase in the incidence of sexually transmitted infections. Had Georgios (“Pap”) not invented his test in “the swinging ‘20s”, someone would have had to do it in the “revolutionary ‘60s”

As it was, Mrs. Sanger had persuaded her wealthy-widow investor friend that this particular “magic bullet”, her idea of a “magic pill”, was the right approach to reproductive management. Thanks to the Pap, the Western world was sort of ready for the consequences of the Pill at least in terms of the ensuing epidemic of STDs, if not of the epidemic of infertility and of other as yet poorly recognized consequences of this fooling with Mother Nature (à la Ms. Sanger and Mrs. McCormick – “as easy to take as an aspirin”).

The fact is that “while an estimated 1 in 4 Americans will get an STD (sexually transmitted disease) in their lifetime,4 … the United States continues to have the highest STD rates of any country in the industrialized world.2 No effective national program for STD prevention exists… and the American public remains generally unaware of the risk for STDs and the importance of prevention and screening” (per the Kaiser Family Foundation and American Social Health Association).

The National Cervical Cancer Coalition writes:

“By age 24, at least one in three sexually active people are estimated to have had an STD. Teenage girls are especially vulnerable to contracting gonorrhea and chlamydia, which can more easily infect the immature cervix.”

Perhaps you have gathered, from the various bioZhena’s Weblog articles and from our other web information, that we propose to do something about it – about making possible private screening at home for early warning devoid of the problems associated with the Pap smear test.

Oskar Kokoschka, Rejected lover, 1966

Oskar Kokoschka, Rejected lover, 1966

Originally, I intended to illustrate these concluding thoughts with a painting by the grandson of Sigmund Freud, Lucian or Lucien, who passed away the other day (a painting of a sad woman’s face showing from under a bed cover, with a clothed man – guess who – standing hands in pockets and just staring at her – it’s #5 in http://pul.se/muse_Cleveland-Cleveland-OH-caroline-blackwood-2LYALDu533r,d5oww4DQguiE).

But then, Oskar’s more colorful impressionist image seems, well, more colorful, and less realistic… as paintings go.

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.

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

March 23, 2010

Comments on a report of two studies http://www.usccb.org/prolife/issues/nfp/cmr_winter-spring09.pdf – they report on what we will call peri-ovulation methodologies.

JUST LIKE THEIR PREVIOUS REPORT IN 2003 [http://www.nccbuscc.org/prolife/issues/nfp/cmrsumfl01.htm ] OF A STUDY WITH THE PERSONA MONITOR, “LIMITATIONS” OF THE TWO STUDIES THEY REPORT ON ARE POINTED OUT BY THE AUTHORS.

Michelangelo - The Drunkenness of Noah

Michelangelo – The Drunkenness of Noah

Excerpts from their first study:

The retrospective study involved 204 couples (i.e., women with a mean age of 28.6 and their male partners, with a mean age of 30.3) who were taught NFP (by health professionals, physicians and nurses) at four sites in the United States

Table 1. Twelve months total unintended pregnancy rate [number of unintended pregnancies out of the number of couples in given group using the indicated method of NFP]

BBT + mucus                                    5/76                     7%

Monitor + mucus                               4/69                     6%

Mucus only                                       1/29                      3%

BBT + mucus + monitor                     2/25                      8%

Monitor only                                      0/5

Second study excerpts:

The participants for this study came from the same four clinic sites as the previous study and involved 313 couples who were taught how to avoid pregnancy with the EHFM [Monitor] plus CVM [Mucus], and another 315 who used CVM only … The researchers found a total of 28 unintended pregnancies with the EFHM plus CVM group and 41 with the CVM only group… (during 12 months of use)

Monitor + mucus                          28/313                        9%

Mucus only                                  41/315                        13%

QUOTE: “both studies have limitations in that they were not randomized clinical trials”.

In their 2003 study report, they similarly noted study limitations, but there was also the following: “Of interest is the authors’ statement that only 1% of reproductive age women in the Netherlands use NFP as a means to achieve or avoid pregnancy. The respondents in this study were mostly women who previously used oral hormonal contraception. This seems to indicate that a new technological device such as Persona could attract new couples to use NFP.” QUOTE UNQUOTE.

Quite right. Their statement of what “this seems to indicate” is consistent with what we had found (without any financial backing by a large investor like Unilever) in a survey of 5,000 American women at about the time when the Persona was new to the market in Britain. Out of those who would purchase our self-diagnostic electronic device (which does NOT require any chemical reagents and daily peeing for in vitro diagnostic measurement with imperfect measures), 70% were users of artificial contraception – they would switch to our device. This outcome was separate from anecdotal evidence of numerous letters and later emails asking if they could purchase our device for their use in NFP.

With the above quote in mind, we would broaden the conclusion – about new technology attracting new couples – beyond NFP use, and we would refer instead (i.e. more broadly) to fertility awareness based methods.

Now, before someone should glance at the above reported outcomes of the two studies and quickly jump to a conclusion, we must make some common sense observations about those statistics. Some little words.

Wassily Kandinsky - Little Words

Kandinsky – Little Words

Should someone want to declare that the above Marquette University reported Monitor had a zero failure rate, then it must be noted that, unfortunately, this was zero out of merely 5 cases. Not comparable with anything else in their publication – and hardly very useful for that reason (and because of the small sample size, too).

Similarly: Table 1 might be read as showing that mucus only is better than BBT + mucus + monitor. This could be “legitimately” considered a valid conclusion since the sample sizes are sort of comparable – if “sort of comparable” were considered good enough (76 and 69, respectively, a 10% difference). But the sample size of mucus only (29) is significantly lower than the sample sizes of the BBT + mucus and of the Monitor + mucus groups.

While the unintended pregnancy outcome of the BBT + mucus + monitor group (8%) is sort of comparable to the outcomes of the two groups with the much larger sample sizes where mucus is accompanied by either BBT or by monitor (7% and 6%, respectively), the only really legitimate conclusion or comment is that sample size matters. That is, if we do not want to compare 25 apples with 72.5 oranges (+/- 3.5) and thus come to questionable conclusions.

If all the groups had sample size of 5 and the percentage outcomes were the same, then the conclusion would be fairly legitimate about the superiority of the monitor – except for the equally legitimate complaint that the sample size of 5 is too small.


Michelangelo - The Battle of Cascina

Michelangelo – The Battle of Cascina

Statistics are supposed to be about large numbers. At least about sufficiently large numbers. Sample size of 5 is hardly sufficiently large, although it would do for a proof of concept, which here the concept would be that Monitor alone is by far the best. I would go with that hypothesis BUT I WANT IT TESTED RIGOROUSLY IN PROPERLY DESIGNED CLINICAL TRIALS.

The outcomes of the second reported study contradict the outcomes of the first, with Mucus only now showing the highest failure rate of them all (13%), and, topping it off, Monitor + mucus is now even higher than in Table 1 (9% vs. 6%).

Since the sample size is now much larger than in Table 1 (313 vs. 69, i.e., 4.5 times larger) it is legitimately concluded that the second study carries more weight and therefore the failure rate of the Monitor + mucus methodology is more likely 9% than 6%. This is rather unsatisfactory but still better than Mucus alone at the whopping 13% unintended pregnancy rate. The 13% failure rate with 315 couples is more believable than the 3% failure rate with 29 couples in Table 1. About 10.862068965517241379310344827586-times more believable – to be light-hearted about it, per jocum dixi.

Then again, remotum joco: All this makes for a kind of arithmetic that should not occur in medical research.

The following is a graphical demonstration of how numbers can distort perception and understanding. The same Michelangelo’s Battle of Cascina (since he did not do any battle of statistics or technologies!) after an effect that allows the data on the periphery to dominate or simply affect disproportionally that which was in the center of focus.

See in the picture above the man looking intently toward us from the middle of the melee? Now (below) he is tiny compared to what’s around him; much like when – in a study of birth distributions as a function of the day of cycle on which conception took place – the data point outliers are doing the same to the high birth counts, because of inaccurate means of ovulation detection (actually mere estimations) employed in said study.

Michelangelo - The Battle of Cascina - Fish Eye effect -30

Michelangelo – The Battle of Cascina – Fish Eye effect -30

While such distortions happen with all imperfect measures of ovulation, the study by John France et al. was discussed in an earlier post at https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ and in the document attached to that post, https://biozhena.files.wordpress.com/2007/12/fetal-sex-preselection-illustrated.pdf .

We subsequently showed, in https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit/, the effect of doing away with the outlier data points by means of the following diagram, which can be likened to removing the Fish Eye Effect -30 from the distorted Michelangelo picture just above to get back his undistorted Battle of Cascina (with all those naked Florentine soldiers surprised by the enemy while bathing).

Ovulona (FIV) fertile window vs. old (fuzzy ovulation estimate) methods

Ovulona 3-day fertile window versus old methods’ fuzzy estimation of the fertile period

Now, one more citation from the paper under discussion. QUOTE: The EHFM [Monitor] is a hand held device that reads a threshold level of urinary metabolites of estrogen (estrone 3 glucuronide) and luteinizing hormone (LH; on test strips) and provides the user with a low, high, and peak reading of fertility. The monitor is sold in the United States as a method to help couples achieve pregnancy but can be used as an aid to track fertility. QUOTE UNQUOTE

This statement reflects the thinking in those circles. But note: Because no single hormone determines the beginning and no single hormone determines the end of the fertile window (whether they know this or not) they have to speak of low, high and “peak reading of fertility”. We have previously referred to this as a fuzzy delineation of the fertile window [https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ].

A little bit fertile, then more, and a peak? That is merely a reflection of not having the accuracy to determine the boundaries of the fertile phase.

Salvador Dali - Metamorphosis of Narcissus

Salvador Dali – Metamorphosis of Narcissus

Just like you cannot be only a little bit pregnant, you either can conceive today or not. No such thing as low fertility, only the uncertainty of “low reading”, and of all their readings – including their subjective self-observations. Subjective self-observations refer to the mucus appearance and feel in NFP practice – and if they used that too, the same limitation applies to palpating the cervix.

The most succinct word about all this is as follows:

The old approaches to detecting fertility status are to be referred to as peri-ovulation methods. Where the prefix refers not to the Peri of Persian folklore (earlier regarded as malevolent!) but to the Greek meaning of about, around, near or enclosing – in this case ovulation. Surely, peri-ovulation or peri-ovulatory is a more palatable word than fuzzy.

STOP PRESS

And now, go and check out the 2012 post “The fallacy of ovulation calculators, calendars and circulating-hormone detectors” at https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Major studies decades ago revealed variability of menstrual cycles

March 10, 2010

But people are still naïve about the basic cause of the difficulty to achieve pregnancy

Sex education at school, its quality or otherwise, is likely to have much to do with fertility problems later in life. Many women (men, too, of course) can use the  keyboard with all their fingers (as well as their thumbs!) but have poor understanding of the basic functioning of their reproductive system.

colonial classroom

colonial-classroom.jpg

That ignorance is well known, and is underlying the fertility problems. You should see the pregnancy doctors’ tweets – replying to some incredible questions, and then the talk of various mysteries!

A shining example is this tale of “mysterious conception”. For the whole story see the Alphabet of bioZhena under M, “Mysterious conceptions (OR THE NONEXISTENCE THEREOF)” on page 34 or thereabout, from which I cite:

QUOTE:  It appears that we must dwell on this topic, because of stories and notions propagated in various pertinent circles. This writing has been prompted by page 176 in the excellent 1999 book “Woman” by Nathalie Angier, where the Pulitzer laureate relates the story of the mysterious conception of her only child. Mysterious, because it occurred, she believes and makes her readers believe, outside of ovulation and of the fertile window.

The reason for this entry in the Alphabet of bioZhena is that there is NO SUCH THING AS MYSTERIOUS CONCEPTIONS, there is only lack of information, or ignorance of the facts. We might say, intellectual misconceptions lead to “mysteries” in terms of conception, of babies conceived supposedly when conception was biologically impossible, and vice versa, some women have difficulties conceiving for the same fundamental reason. We shall use Ms. Angier’s case to make this point. UNQUOTE.

To drive the point home, here is an excerpt from John J. McCarthy, Jr. and H.E. Rockette, “Prediction of ovulation with basal body temperature”, Journal of Reproductive Medicine, Volume 31 (No.8), Supplement, 742 – 747, 1986.

Referencing particularly large studies from 1967 and 1977, these BBT experts had this to say all those years ago (and never mind their “prediction” in the cited title whereas the BBT is well known to be no predictor):

QUOTE:  Cycle regularity is often assumed by both women and their physicians. The suggestion, that the BBT graph of the previous cycle can be used to identify the day of ovulation in the current cycle, requires nearly absolute cycle regularity. [However, note this:] The data collected by 1,085 women, who provided at least 6 or more charts each, were studied for cycle length variability. … The cycle length range was more than five days for 56% of the women who submitted 6 graphs, and for 75% of those with 12 graphs. … Absolute regularity was not demonstrated in as few as six cycles. Even when the cycle length that deviated the most was eliminated, less than 1% (8 of 1,085 women) had no variation in cycle length. When the number of cycles was extended to 12, no woman had variability of less than two days in cycle length. END OF QUOTE.

In real life, you realize, no cycle can be eliminated from the experience, and every day matters. Two days are very likely to make the difference between conception and the lack of it. And/or cause an unwanted pregnancy, for that matter.

middendorf_on_the_ball.jpg

Middendorf  – On the ball

The above findings are therefore the basis on which we can say quite categorically that nobody is as regular as a metronome (and nobody conceives in an anovulatory cycle), that there is no such thing as absolute regularity, whether 28 days or otherwise.

If you are in the sub-fertile category of people finding it difficult to become pregnant, you are likely to have cycle variability of more than 5 days over those months of your fruitless efforts that define your category. More likely than being one of the 0.74% of the population with no variation in cycle length, which under ideal conditions may also mean no variation in the time of ovulation. Persistent monitoring is well advised.

Far more than a tool for getting pregnant and for pregnancy avoidance

March 12, 2009

On symptometric monitoring correlated with folliculogenesis: Why it is essential for effective diagnosis in women’s healthcare

The purpose of this article is to bring to your attention the big picture. That is the fact that the potential impact of the bioZhena technology goes beyond reproductive management. We illustrate how we mean it when we invoke the vision that the Ovulona device will become a friendly routinely-used companion tool with numerous diagnostic ramifications for women everywhere.

The natural interest of the woman-user in being in charge of her reproductive life leads to the possibility of using the information gathered in the process for additional medical purposes, some not so obvious in the context of the menstrual cycle signature. The Ovulona cyclic profile is the signature of the menstrual-cycle vital sign.

Menstrual cyclic profile signature of the HPG feedback mechanism

To enlarge the image, click https://biozhena.files.wordpress.com/2009/03/menstrual-cyclic-profile-signature-of-the-hpg-feedback-mechanism.jpg   The H-P-G feedback loop (F) gives rise to the menstrual cyclic profile signatures.

You will follow the discussion here better if you peruse the bioZhena weblog article, listed under Pages and titled, What is symptometric? What is the meaning of “symptometric data”? The answer in a nutshell: Symptometry means symptoms quantified and charted.

Now for a possible application. You probably do realize that there are gender differences in how patients respond to therapy, and you do not need reminding that cardiovascular disease is a big problem for women’s health, far from killing mainly male victims.

In this context we hint at an electronic interface that will function to navigate through a menu that provides for a daily registration of quantified symptoms by means of one of the standard medical symptometric inventories such as the Calendar of Premenstrual Experiences (COPE), or the Daily Record of Severity of Problems (DRSP), etc. This will replace the paper forms used today, and the data from any number of months stored in the device will be transferred to the patient’s healthcare provider(s). The longitudinal record of menstrual cyclic signatures provides a new means of patient profiling.

The DIU will facilitate electronic recording of quantified symptoms

The DIU will facilitate electronic recording of quantified symptoms. Below we show the planned transformation of the Ovulona into a semi-permanently worn cervical ring telemetric device.

Friendly Tech & Next Gen Design Panorama ed2

See the image better in slide 4 of QUICK INTRO 4 SLIDES at Friendly Technology and Next Generation Design

By design, the symptometric data will be correlated with the Ovulona data on folliculogenesis – and will be far better than the old, inefficient and costly, paper-using procedures of yesteryear (those did not employ any folliculogenesis correlation, of course). No need to invoke the evolving societal requirements in general healthcare policy towards cost-effectiveness, etc.

A recent health news headline declares: “More evidence that depression is hard on the heart”, and here is the synopsis: Severe depression may silently break a seemingly healthy woman’s heart. Doctors have long known that depression is common after a heart attack or stroke, and worsens those people’s outcomes. Monday, Columbia University researchers reported new evidence that depression can lead to heart disease in the first place [http://channels.isp.netscape.com/news/story.jsp?floc=ne-story-9-l9&idq=/ff/story/0001%2F20090310%2F0629929017.htm&sc=1500 03/10/09 06:29 © Copyright The Associated Press].

The issue is not the reported “big surprise: Sudden cardiac death seemed more closely linked with antidepressant use than with the depression symptoms the women reported. That might simply mean that women who used antidepressants were, appropriately, the most seriously depressed, cautioned lead researcher Dr. William Whang. But he said the finding merited more research” [loc. cit.].

The issue is that not only more research but all routine women’s health practice requires the knowledge of how symptoms relate to (correlate with) the course of the menstrual cycle or, more accurately put, the course of folliculogenesis.

For an illustration, refer to Premenstrual syndrome (PMS) and PMDD

Effective therapy requires this differential diagnosis, and our technology will do three things for public health:

1. Enable routine quantitative recording of symptoms,
2. Correlate symptoms with the underlying folliculogenesis process, and
3. Allow for individualization of therapy (titrate medication doses for individuals).

This is one of the examples of non-reproductive applications of the bioZhena planned products; this is simply a reminder that the core product, the Ovulona™ for reproductive management, is far from the only planned product offering.

The Ovulona™ is the core product with various diagnostic ramifications within the bioZhena Fertility and Health Awareness System™.

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.

Birthday, and how it relates to the bioZhena enterprise – eukairosic™ diagnostic tools

December 28, 2007

Today is a major anniversary related to the bioZhena enterprise. Namely, a round-number (and not small) birthday of the offspring whose begetting had much, if not everything, to do with the inception of the project.

The biologically educated member of the would-be parental team insisted that medical help would have to be the very last resort, as she did not wish to be poked in and subjected to the various medical procedures available in the country of the proud Albion (that, alas, no longer ruled the waves!), where this awakening was going on. The image of what she resented getting into is telling, and it’s not even the whole story.

Woman in stirups sketch

Awakening on the part of said couple, who till then took steps to minimize or theoretically avoid getting in the family way, owing to circumstances. As in too many instances the world over, the “awakening” was left until somewhat too late. I do not wish to talk about age specifics, but you probably know that particularly female fertility (more accurately put, fecundity or fecundability) decreases starting around or even before the Christ’s age, and so – in retrospect – it was no great surprise to find that achieving pregnancy was not as simple as expected. At the time, actually, this was a great surprise…

At the time, yours truly was not an expert in the field that deals with certain practicalities of the most important aspect of life, by which many of us mean procreation, reproduction, and its management. I am referring to some insight into the practicalities on the female side of things procreative, which insight was not there at the time – but the better half knew the basic fundamental that I now delight in referencing as eukairosic.

In a nutshell, the word refers to the right time, opportune time – exactly what we are about the strategic or “right time; the opportune point of time at which something should be done.” A window of opportunity is kairos time.

For more about this, the Wikipedia article can be recommended, at http://en.wikipedia.org/wiki/Kairos . Let’s cite: Kairos (καιρός) is an ancient Greek word meaning the “right or opportune moment,” or “God’s time” [sic; thus said – but this should say “gods’ time”]. The ancient Greeks had many gods, and two words for time, chronos and kairos. While the former refers to chronological or sequential time, the latter signifies “a time in between”, a moment of undetermined period of time in which “something” special happens. What the special something is depends on who is using the word. END QUOTE.

If you visit that article, you will probably understand why I would like to look at the possibility of adopting as our company logo QUOTE a monochrome fresco by Mantegna at Palazzo Ducale in Mantua (about 1510 C.E.) that shows a female Kairos (most probably Occasio)… UNQUOTE.

You will also appreciate that, since we are not theologians, and because “eu-“ is the Greek prefix meaning well or good or true or easy, my choice of the adjective that we want to trademark as descriptive of bioZhena’s wares is eukairosic™.

And so here, for the sake of accurate definition, is one other item from The Alphabet of bioZhena – /2007/11/28/the-alphabet-of-biozhena/

Fecundability and fecundity:

Fecundability is the probability of achieving pregnancy within one menstrual cycle – about 20% or maybe 25% in normal couples [sic; the probability depends on many factors, including age – vide infra, or see below].

Fecundity is the ability to achieve a live birth.

Fecundability is strongly influenced by the age of the partners, and it is maximal at about age 24. There is a slight decline at ages 24 – 30, and a rapid decline after age 30.

The words are derived from Latin fecundus, fecund, from the root of fetus, via Old French fecond. Fecund means fruitful in children, or prolific.

As for the eukairosic diagnostic tools, their utility goes beyond reproductive management. Due to folliculogenesis (menstrual cycling), even things such as administration of medications or certain diagnostic examinations must be performed at the right time within the menstrual cycle…

Scire quod sciendum

fecundoscitus!!! 🙂

Thus spoke the exegete and father of Barnaby and Petrushka, Vaclav Kirsner © 2007

 ‘To know what is to be known’.

MENOPAUSE, HRT, AND BIOZHENA

December 18, 2007

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

You’ll find much more there under Menopause, HRT, and bioZhena.

Klimt’s Medicine mural

The OvulonaTM is an individual woman’s health monitoring tool, primarily responsive to her steroid hormone profile. As such, it may be expected to become useful for the management of menopause, and specifically for the individualization of HRT (hormone replacement therapy) or for the monitoring of the effects of any alternative approach to menopause management. See also under Hot flushes (or flashes) and under End-organ effect, below.

The concept of individualization of HRT has to do with the adjustment of hormone dosages, so as to minimize the drugs’ harmful side effects. The bioZhena technology is an objective and quantitative monitor of the effects of steroid hormones – whether endogeneous or exogeneous (own-body-generated versus administered). On this basis, it is expected to be a meaningful tool for menopause management, both in the hands of health providers as well as conceivably in the hands of the end-users themselves. Besides causing the Ovulona to become a widely used personal tool for women’s health management in the reproductive years, there is a good chance that the technology will naturally extend its usefulness into the post-reproductive years.

Hormone replacement therapy (HRT):

The use of synthetic hormones, particularly estrogen, to replace the menopausal woman’s diminished naturally self-generated supply of hormones. Prescribed to alleviate menopausal symptoms such as hot flushes, as well as to prevent osteoporosis. Menopause and HRT – initially as “estrogen replacement” or unopposed estrogen – did not come into vogue as a topic of concern for the medical profession until the 1960s, when chemical contraception was introduced.

It is interesting to note that in countries in Asia and South America, where women eat either wild yams or soybeans, which are sources of progesterone, the term “hot flush” does not even exist in their languages. They also rarely suffer from the host of female problems presently plaguing Western women.

It is a fact that an estimated 40 to 50 million American women are now 50, the approximate average age of menopause onset. We believe that the Ovulona will be useful in menopause management in general, and personalization of HRT in particular. The latter has to do with the minimization of side effects of HRT. With respect to that, note that the risk of developing breast cancer, particularly the lobular subtype, is elevated with ‘recent long-term’ use of hormone replacement therapy. This according to a report published in the February 2002 issue of the Journal of the American Medical Association.

For more details, see Another study implicates HRT in breast cancer at http://www.lef.org/whatshot/2002_02.htm (and also http://news.bbc.co.uk/1/hi/health/3018930.stm, or google on HRT report risk of developing breast cancer).

See this April 2007 article at http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=44377, which states that as a result of said report, millions of women ceased use of the drugs. Prescriptions for HRT declined by at least 38% in 2003 and by an additional 20% in 2004. Researchers found that in 2003 and 2004, 30,000 fewer women developed breast cancer than would have been predicted by previous trends, and the incidence of breast cancer reached its lowest rate since 1987. Researchers estimate that 16,000 fewer cases of breast cancer are being diagnosed each year because of the decline in HRT use, but experts argue that HRT should not be discontinued or abandoned.

HOT FLUSHES (OR FLASHES):

During the menopausal years, many women experience severe multiple symptoms, to a greater or lesser extent, depending on the individual. In fact, 70% of women experience hot flushes within 3 months of a natural or a surgical menopause. With some, the menopausal impact of estrogen deprivation can go unnoticed. The hot flush – or, medically, the vasomotor flush – is viewed as the hallmark of the female climacteric, experienced to some degree by most menopausal women.

The term is descriptive of a sudden reddening of the skin on the head, neck and chest, which is accompanied by a feeling of intense body heat and often by profuse perspiration. The duration varies from a few seconds (about 30) to several minutes, and rarely an hour or so. The episode ends usually in profuse sweating and a cold sensation. The hot flush frequency may be from rare to recurrent every few minutes, and the flushes are more pronounced at night or during times of stress. The disturbance of sleep results in fatigue, which may in turn lead to irritability, poor concentration, impaired memory, and other deterioration of quality of life. The vasomotor flushes are less frequent and less intense in a cool environment such as in winter months in the northern hemisphere. They can occur in pre-menopause, and are a major feature of post-menopause, lasting in most women for one or two years, but in as many as 25 – 50% of women for longer than 5 years. Unlike other aspects of menopause, hot flushes lessen in frequency and intensity with advancing age.

The physiology of the hot flush is still not well understood, but it apparently originates in the hypothalamus (in the brain) and is brought about by the decline in estrogen at menopause. Vasomotor flushes appear to result from a sudden lowering of the hypothalamic thermoregulatory set point. Activation of cutaneous vasodilation (increased blood flow into skin vasculature) causes an increased peripheral blood flow and thus heat loss, leading to a fall in core temperature. There are hormonal consequences as follows: About 3 to 6 minutes after the flush onset, epinephrine increases in blood (but not norepinephrine), and corticotropin acutely rises 5 minutes after the flush onset, leading to increases in cortisol (15 minutes), androstenedione (15 minutes) and dehydroepiandrosterone, DHEA (20 minutes). While luteinizing hormone (LH) increases and peaks about 12 minutes after the onset, growth hormone also rises, about 30 minutes after the flush. On the other hand, estrogen levels, as well as prolactin, FSH and TSH (follicle-stimulating and thyroid-stimulating hormones) remain stable during hot flushes.

The flush may be preceded by palpitations or headache, and is often accompanied by weakness, faintness, or vertigo. It is understood in gynecology that 10 to 25% of women report hot flushes before menopause, and that women are often treated unnecessarily with estrogen for this relatively common psychosomatic symptom.

In brief, the flush is not a release of accumulated body heat but is a sudden inappropriate excitation of heat release mechanisms. Its relationship to the LH surge and temperature change within the brain is not well understood. It is understood that the flushes are a consequence of the withdrawal of estrogens, rather than of hypoestrogenism (low estrogen levels) per se. The discontinuation of administered estrogens may also precipitate hot flushes, which may also be caused by the infertility drug clomiphene citrate (a nonsteroidal inhibitor of estrogen receptors in the brain).

Obese women tend to be less troubled by hot flushes (because they are less hypoestrogenic).

An estimated 40 to 50 million American women are now 50, the approximate average age of menopause onset, and so it is not surprising that there is much discussion about whether hormone replacement therapy (HRT, see above) causes breast cancer or whether natural hormone creams are effective. The average woman experiencing the onset of menopause can get lost in all the controversies — especially if she is already losing her normal composure because of distressing hot flushes and night sweats.

The bioZhena technology is expected to become a useful tool for the management of menopause, and specifically for the individualization of HRT or for the monitoring of the effects of any approach to menopause management. The concept of individualization of HRT has to do with the adjustment of hormone dosages, so as to minimize the drugs’ harmful side effects.

Alternative approaches include various uses of plant products with natural estrogenic and anti-estrogenic effects that balance and augment the body’s hormone levels. For example, in The Hot Flash Cookbook (Chronicle Books, 1997), author Cathy Luchetti shares her thoroughly researched and tested nutritional solutions for relief of menopausal symptoms. In “No More Hot Flashes!” ( http://216.205.123.2/whatshot/whatshot45.shtml ), Luchetti is quoted saying, “I couldn’t accept the very idea of HRT. I have never believed in pill-popping or other synthetic approaches to health. Yet, I had to do something, because I felt as if my once-dependable body and upbeat attitude were being chiseled away, bit by bit. And being a historian, I kept recalling all the Victorian stories of menopause that ended with the woman becoming ‘unhinged by the change of life.’ I refused to accept that as my fate.”

Luchetti’s words may be considered symptomatic of the attitude of many women today, and bioZhena is in tune with these changing attitudes. Unfortunately for some, though, with addiction and consumerism being what they are, some of our “thoroughly modern Millies” (pun intended) find it almost impossible to recognize that “…to try for hot-flash relief, you should avoid certain foods if you can — especially spicy foods, caffeine, and sweets. Drinking alcohol can also trigger hot flashes”. For those, there exist some over-the-counter herbal supplements “for ridding oneself of hot flashes and other menopausal symptoms”.

As an objective and quantitative monitor of the effects of endogeneous or exogeneous (own-body-generated versus administered) steroid hormones, the bioZhena technology is expected to be a meaningful tool for menopause management, both in the hands of health providers as well as conceivably in the hands of the end-users themselves. This is a logical expectation because some women, especially those still having menstrual cycles, have apparently found that nutritional supplements (such as Dong Quai or Licorice Root) actually aggravated their symptoms. The proponents of these supplements argue that some of the herbs “don’t agree with every woman” and that it is necessary to “give it time and carefully observe its effects in your body.” As in any other situation, a good diagnostic tool is a highly advisable proposition.

Michelangelo’s Sybille de Cummes

End-organ effect:

A concept of biomedicine, which has to do with monitoring of the effects of stimuli, usually chemical stimuli such as drugs, on a biological system, that is either a part of or the complete body of an animal, or a human subject. While the fate of a chemical compound can be monitored by detecting it in body fluids (blood, urine, saliva, etc.), it can also be monitored by measuring the effect on a certain part of the body, called the end organ because the stimulus ends up there. The same applies to stimuli and reactions that the body generates by itself. bioZhena explores electronic monitoring of end-organ effects.


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