Posts Tagged ‘intercourse’

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. 

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.

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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.

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

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

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

These are fundamental principles.

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

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

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

That’s what the Ovulona from bioZhena is for. Personalized medicine. Evidence based medicine.

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

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

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

HCG or Human Chorionic Gonadotropin laboratory signature

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

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

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

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.

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.

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’.

Fetal sex pre-selection – the fundamentals

December 15, 2007

For this and the various related concepts and terms, see the Alphabet of bioZhena at

/2007/11/28/the-alphabet-of-biozhena/

Fetal sex pre-selection:

Here is the underlying principle: Out of the 46 chromosomes (23 pairs), the last pair is the sex chromosome. It is of the XX type in the female and XY type in the male. The ovum (egg) has X type chromosomes only, while 50% of the sperm have X chromosomes and 50% have Y chromosomes. If an X sperm fertilizes the egg, this results in an XX combination, which is a female offspring. If a Y sperm fertilizes the egg, the result is an XY combination and a male child.

According to http://www.fertility-docs.com/fertility_gender.phtml , “the selection of gender has been a quest of couples for as far back as recorded history allows. Early drawings from prehistoric times suggest that sex selection efforts were being investigated by our earliest ancestors. Later history shows intense interest in sex selection by early Asian (Chinese), Egyptian and Greek cultures. This is followed by documented scientific efforts beginning in the 1600s to sway the chances of achieving a pregnancy by a variety of methods…” QUOTE UNQUOTE

Two approaches to sex selection have been demonstrated in the current scientific literature. One approach employs the tools and methods of assisted reproductive technologies (ARTs), manipulating the genetic material of the sperm prior to artificial insemination, so as to facilitate fertilization by the selected one of the two genders of the spermatozoa. The other approach attempts to enhance the probability of conceiving the desired gender by appropriate timing of the conception event with respect to ovulation. This is a highly controversial subject despite the fact that a substantial body of work on it has been published.

Thus, a 2001 publication by respected experts from a premier infertility treatment institute (G.Hodgen et al., see below) has put forward evidence that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing).

This is consistent with earlier findings by Auckland, New Zealand researchers that boys tend to be conceived earlier in the fertile period than girls (the earlier conception requires a longer lifetime of the sperm). This was discussed in our two previous posts: /2007/12/02/regarding-fetal-sex-preselection/ and /2007/12/03/fetal-sex-preselection-illustrated/ .

A 1991 Johns Hopkins University meta-analysis of six NFP studies concluded that the data showed “a statistically significant lower proportion of male births among conceptions that occur during the most fertile time of the cycle”, meaning near ovulation. Indeed, the Auckland study by Professor John France’s group found that 65% of male infants were conceived 2 to 5 days before ovulation while “71% of the born girls were conceived from intercourse timed between 1 day before to 1 day after the estimated time of ovulation”. This was based on 55 births. See the referenced previous posts.

Notes:

1) Hodgen et al. paper on different survival times of X and Y sperm:

Andrologia, Volume 33 Issue 4 Page 199 – July 2001
Differential binding of X- and Y-chromosome-bearing human spermatozoa to zona pellucida in vitro
Q. Van Dyk, M. C. Mahony and G. D. Hodgen

2) We might refer to the second, the correct-timing, approach to fetal sex pre-selection as eukairosic. This [Eukairosic™] with reference to http://www.perseus.tufts.edu/cgi-bin/lexindex?lookup=kairo/s〈=Greek

kairos III. more freq. of Time, exact or critical time, season, opportunity… … …

3)  France et al. paper with data on fetal sex pre-selection by timing intercourse:

J.T. France, F.M. Graham, L. Gosling, P. Hair and B.S. Knox, “Characteristics of natural conception cycles occurring in a prospective study of sex preselection: fertility awareness symptoms, hormone levels, sperm survival, and pregnancy outcome”, International Journal of Fertility 37 (4), 224 – 255, 1992.

For more about fetal sex pre-selection, see “Fetal Sex Preselection – Illustrated” at https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/

Fetus:

The organism that develops from the embryo at the end of about seven weeks of pregnancy and receives nourishment through the placenta. Fetus, plural fetuses:

1. The unborn young of a viviparous vertebrate having a basic structural resemblance to the adult animal. Viviparous: Giving birth to living offspring that develop within the mother’s body. Most mammals and some other animals are viviparous. Vertebrates have a backbone or spinal column.

2. In humans, the unborn young from the end of the eighth week after conception to the moment of birth, as distinguished from the earlier embryo. [From Latin fetus, offspring.]

Embryo:

The embryo is the organism that develops from the pre-embryo, and begins to share the woman’s blood supply about nine days after fertilization. Approximately one-half of all human embryos are abnormal [ http://www.columbialabs.com/html/crinwom/infertility/fertilization.htm ]. QUOTE: “There is fortuitously a biologically based selection bias against abnormal human embryos. A signal is obviously recognized by the mother, which helps explain why so many embryos fail to implant. An abnormal embryo that manages to implant is often miscarried in the first 10 weeks of pregnancy. Early miscarriages are almost always the result of abnormal development of the fetus. This is why progesterone is not usually recommended for threatened abortion. It is only if the physician can confirm, using ultrasound, that the fetus is viable, will he prescribe progesterone to help maintain the pregnancy.”

Veterinary fetal sex pre-selection:

A similarly high level of interest in embryo sexing (fetal sex pre-selection, or sex ratio) exists in the livestock industries, and researchers have experimented with the timing of insemination method. A tool such as the bioZhena Corporation’s BioMeter is indispensable for this approach to embryo sexing, because of the required accuracy and precision of the timing. The controversy in the veterinary literature is a clear evidence that timing the insemination merely with respect to estrus is not good enough. The timing must be with respect to ovulation. The BioMeter, which detects ovulation as well as anticipating it, should make it possible to investigate questions such as whether different species have different lifetimes of the sperm. It should be possible to establish what kind of a distribution of sperm lifetimes there may be within a species. (See also under Timing of insemination.)

The 2001 book Biotechnology in Animal Husbandry (R. Renaville & A. Burney, editors, Kluwer Academic Publishers) has a chapter on Sex Preselection in Mammals. The abstract states: Since a long time, sex preselection has been a goal of the dairy and meat industry to increase the rate of response to selection, to reduce the cost of progeny [offspring or descendants] testing for elite males, and to produce desired specialized and genetically superior offspring. The authors write: In animal husbandry, pre-selection of sex prior to conception will dramatically impact a farmer’s productivity and income, because in each of the chosen target industries there is a strong preference for one sex over the other. For example, the dairy industry must have females to produce milk whereas the beef industry prefers males for their higher quality and lower cost of production. Sex pre-selection is one of the most sought after biotechnologies of all times.

In a section on Factors Affecting Sex Ratio, the experts write: Considerable folklore particularly in humans has arisen regarding preconception methods to manipulate animal sex ratio. The authors point out that conventional wisdom holds that steroid hormones play no role in sex predetermination in mammals, and it is only after gonadal differentiation that steroids sculpt the characteristics, which distinguish males from females. They also write that, for a number of years, the time of insemination or mating during estrus has been believed to influence the sex ratio of offspring, and they review various conflicting reports in several animal species. One kind of these results, in cows, indicates that the sex ratio may be affected by the maturational state of the oocyte [egg] at the time of insemination (yielding sex ratio 0.7 when inseminated immediately after, and 2.5 when inseminated 8 hours after polar body extrusion, which basically refers to ovulation timing). In their Conclusion, the experts again point out that “economics dictate that livestock producers are under increasing pressure to produce a given number of progeny of the desired sex.”

The results of sex pre-selection experiments depend on the state of the ovulating egg and of the sperm. This may depend on whether a given father belongs into a sub-population of males with long or short sperm lifespan. Whether there is such a thing as this kind of categorization within a species can only be established by means of a tool such as the Ovulona/BioMeter.

This holds for all species, including Homo Sapiens, of course, and public health statistics make such categorization actually quite likely. In the U.S., the sex ratio (number of males born per 1000 females) has declined from 1.052 in 1983 to 1.049 in 1999, having been as low as 1.047 twice in the late nineties. Interestingly, this decline is evidently due to the decline in the white race (from 1.057 to 1.052, through as low as 1.049) whereas for the black race the sex ratio has actually increased over those years (from 1.028 to 1.031, through as high as 1.036) [web reference: http://www.infoplease.com/ipa/A0005083.html ].

All this is suggestive of a likely strong reason why people will want to use the bioZhena [eukairosic] products, and the application will not even need to be advertised.

Infertility and A.R.T. or Assisted Reproductive Technologies

December 15, 2007

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

/2007/11/28/the-alphabet-of-biozhena/

 

 

Infertility:

Clinical infertility is the inability of a couple to achieve a pregnancy or to carry a pregnancy to term after one year of unprotected intercourse. If the difficulty to conceive lasts less than a year, the condition is referred to as reduced fertility or sub-fertility (see the previous post at /2007/12/14/sub-fertility-or-reduced-fertility/ ). Clinical infertility is classified further into male infertility, female infertility, couple infertility, and unexplained infertility. Studies have shown that in the past 50 years the quality and quantity of sperm has dropped by 42% and 50% respectively. In the past 20 years the decrease in sperm counts has occurred at a rate of 2% annually. For further information refer to Xeno-estrogens (see the Alphabet of bioZhena at /2007/11/28/the-alphabet-of-biozhena/ and the web reference therein).

In the U.S. alone, of the 6.7 million women with fertility problems in 1995, 42% had received some form of infertility services. The most common services were advice and diagnostic tests, medical help to prevent miscarriage, and drugs to induce ovulation [Fam. Plann. Perspect. 2000 May-Jun;32(3):132-7].

 

 

 

A Glossary of Infertility Terms and Acronyms published by the InterNational Council on Infertility Information Dissemination is available at http://www.inciid.org/glossary.html .

 

 

ART or Assisted Reproductive Technologies:

 

Also referred to sometimes colloquially as the “heroic procedures”, they are used to treat infertility patients. ART refers to all techniques involving direct retrieval of oocytes (eggs) from the ovary. They are: artificial insemination (AI), IVF (in vitro fertilization), TET (tubal embryo transfer), ZIFT (zygote intra-fallopian transfer), GIFT (gamete intra-fallopian transfer), ICSI (intra-cytoplasmic sperm injection), blastocyst transfer and other infertility treatments, such as IUI (intra-uterine insemination), assisted hatching (AZH), and immature oocyte maturation (IOM).

Web reference: http://www.ebiztechnet.com/cgi-bin/getit/links/Health/Reproductive_Health/Infertility/Education/Assisted_Reproductive_Technologies/

 

 

Sub-fertility or Reduced Fertility

December 14, 2007

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

/2007/11/28/the-alphabet-of-biozhena/

Subfertility (THE INITIAL TARGET OF BIOZHENA):

A state of less than normal fertility but not as bad as clinical infertility. Also called reduced fertility, it refers to the inability to conceive for more than about 4 months but not more than a year (which then becomes classified as clinical infertility, the inability to conceive after a year of unprotected intercourse). It is estimated that as many as one in six couples (17%) have difficulty in conceiving the number of children they want when they want them.

Again: Research suggests that between 14 and 17 percent of couples are affected by subfertility at some time during their reproductive lives. In fact, only eight out of 10 couples trying for a baby do get pregnant within 12 months. For approximately 10 percent of couples, pregnancy will still not have occurred after two years (clinical infertility). Sometimes the label of subfertility is used for couples who have had regular unprotected sexual intercourse for all of two years without conception taking place. This is a reflection of the fact that subfertility is becoming more and more commonplace.

According to one source ( http://www.womens-health.co.uk/ ), even for a healthy fertile couple, the ‘per month’ success rate (conception rate) is only around 15-20%, “so it is not at all uncommon to take some months to conceive”. Overall, around 70% of couples will have conceived by 6 months (a 30% subfertility rate). 85% conceive within 12 months (a 15% subfertility rate, “for the less impatient”). And 95% will be pregnant after 2 years of trying (technically, this is a conservatively estimated infertility rate of 5% – c.f. the 10% referenced above; or, this statistic might be perhaps considered the subfertility rate for the angelically patient). The monthly success rate in this population is 8%, and this statistic drops progressively as time goes on.

As for possible causes of difficulty to conceive, alcohol consumption, even in small amounts, can reduce a woman’s chance of conceiving by more than 50 percent, and smoking “…drastically reduced fertility in our sample”, as wrote a team from the Baltimore-based Health Care Financing Administration, in a report published in “Fertility and Sterility” (1998; 70: 632-637).

In terms of help, many people believe that fertility drugs, even when effective, remove conception from the intimate relationship between the partners, which means that it is to some extent beyond their control. Besides this loss of control, there are drawbacks and disadvantages to all forms of medically assisted conception. Some of them have potentially serious long-term effects. Consequently, many couples prefer to avoid these risks.

Women who describe overcoming infertility with the help of alternative therapists went to them because they had been offered drugs to induce ovulation but were reluctant to take them, when they learned of the possible side effects. Disturbing reports have appeared about the long-term as well as short-term effects of assisted conception. Increased miscarriage levels and premature and multiple births are not only very distressing but have considerable cost implications, both personally and societally (i.e., this is a public health issue). Babies born prematurely, or in multiple births, are at a disadvantage from the start. There are also some reports of increased rates of ovarian cancer in women who have taken fertility drugs, and of cancer in the babies of mothers who have had ovulation induced by drugs.

Subfertile couples are naturally interested in methods and tools that can help them to overcome the difficulty to conceive. The endocrinologist professor Brown may be quoted: “Failing to conceive when wanted is stressful and therefore favours infertility. It should be remembered that, apart from a few conditions such as blocked fallopian tubes, absent sperm and continued anovulation, most couples will conceive eventually without help. However, the modern expectation is one of immediate results, and the main function of assisted reproduction techniques is therefore to shorten the waiting time for conception.” To which we would add that bioZhena aims to offer a more affordable and safer alternative.

With the mentioned statistics of the fertile-age women suffering from the subfertility problem, this is a truly large opportunity in a constantly renewing and growing market. We are talking about 9 or 10 or even 18 million women in the USA alone – or quite possibly many more, taking into account all the impatience and demand for instant gratification in people today; plus about 50% of the 10 million of clinically infertile US couples, that is those who cannot afford the very costly ART treatments. [A.R.T. = Assisted Reproductive Technologies.]

This is the initial, early-stage, mission of bioZhena Corporation: To provide a definitive timing aid to couples experiencing difficulties in conceiving a baby. See also the entry for the Ovulona, where it is explained that, in this situation of reduced fertility, the basic problem is the proper timing of the intercourse.

 

The Elevator: Swiss VC/PE deal-maker offers bioZhena to their investors

December 7, 2007

The Elevator, “The Magazine for a Wealth of Opportunity”, December 2007

 

This post is about the integral and unavoidable aspect of project development – seeking development capital. The title could conceivably read “From Switzerland With Love”, if a play on words were intended. Such as the name of The Elevator magazine is a reference to the phrase “elevator pitch”, a standard concept in the venture capital/private equity arena (meaning a very brief introductory pitch of the investment proposition; The Elevator articles are naturally somewhat more extensive than that).

The editor of The Elevator reviewed and published bioZhena after we responded to their invitation, “Seeking Deals to Fund”, http://www.linkedin.com/pub/0/456/786 .

The Elevator (“The Magazine for a Wealth of Opportunity”) is an impressively produced electronic magazine, attached. On page 3, the editor writes: “…since our first issue in March 2006 we have reviewed over 300 projects and retained 60 of them as features. More than 10,000 individuals have seen The €levator ; we’ve had a great diversity of projects, much interest and several deals closed over the past 12 months. … I invite all our readers to become active members of our investor’s forum …“.

On page 35 appears the following claim: OUR TEAM OF EXPERTS PROVIDES ACCESS TO THE BEST SOLUTIONS IN PRIVATE EQUITY, ASSET MANAGEMENT AND VIP ADVISORY.

Here are the headlines from the magazine’s title page, featuring a partial list of contents, and bioZhena is one of these featured listings:

  • How to open your own fund. An introduction by the experts of JP Fund Services
  • bioZhena. The turnkey technology for birth control
  • VentureLab. The professional matching platform
  • The Village Barbados. Prime Luxury Retreat seeking USD 31 million

The interesting thing about this presentation of bioZhena, by the Geneva-area international business VC/PE deal-maker, is their risk scale. We see a scale with 6 colors, from green and light green, through yellow, then light pink and dark pink, and finally the highest risk level is red.

The editor indicates the risk level of the bioZhena proposition as between light green and yellow (or level 4 on a scale of 1 to 11). This is the same as that of the real estate deal “The Village Barbados”, and it is better than the level 5 [yellow] risk level of the VentureLab deal, and it compares favorably with the various other listings in this December issue of the Elevator. Only the Yacht Club Mediterranean and the Castellan, New York real estate deals are assessed with lower risk levels, 2 and 1 respectively.

It is also interesting that bioZhena’s risk level is assessed the same as that of DealFlow, Toronto – “a television series that captures the drama and sport of global business as seen through the eayes of dealmakers”. DealFlow “is currently seeking US$620,000 in a US$875,000 Private Placement Offering of Convertible Preferred shares at US$20.00 per share”.

bioZhena’s investment opportunity is described as follows:

Investment Volume: Up to $ 15 Million (current Offering for $3M plus 1-year $3M Warrant)

Est. Return on Investment: 100%+

Est. Duration: Approx. 3 Years

Minimum Investment: $250,000 or a portion thereof at Company’s discretion

 

Ref.:

The Elevator, “The Magazine for a Wealth of Opportunity”, December 2007

Fetal sex preselection – illustrated

December 3, 2007

Ovulona and logo

In the document attached to this post (below), we say:

The following illustration is adapted from one of our slides. The slide indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace. The data were generated in a clinical study performed with our early prototype by an independent OBGYN academic. The data show the morning and evening cyclic profiles from one of the baseline subjects studied by the gynecologist Dr. Benedetto of the University of Turin, Italy.

This is a record of one menstrual cycle of a 30-years old woman participating in the Italian clinical test. The record shows the typical features of the Ovulona cyclic profile. In these early tests, the measurements were taken twice daily (morning and evening) in order to see if a time-of-day effect could be observed, and the BBT (Basal Body Temperature) was taken in the usual manner as a reference parameter.

Here is the slide:

The three-day fertile window how-to

The record shows that the features of the cyclic pattern – reproducible because the same features were also obtained by other women – make it possible to determine the boundaries of the fertile window. The precision is such that it allows for correlation of fertile day 1 with trying to conceive a boy, and correlating fertile day 3 (the ovulation day) with trying to conceive a girl. Correlating each of the 3 fertile days with the indicated likely gender of the baby conceived on the given day is based on the results of certain studies by other investigators (John France et al.), as referenced below.

The outcome of their clinical work is consistent with the finding a decade later – by other investigators in 2001 – that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing). The France et al. results from timed-conception birth-giving patients stand by themselves but it is nice to have available the separately produced physiological rationale that explains those results; read on.

And here is in a nutshell the clinical trial evidence for the 3-day fertile window:

.
3-day window data from a study by John France et al.
.

This is a re-plot of their data (from 55 births) of birth counts as a function of the cycle day, whereby the outlier data points were considered to belong, in fact, to the counts of the three days of high birth counts, the outliers having been due to their inaccurate and unreliable methods of estimating the time of ovulation. The problem will be resolved when, instead of the old imperfect methods of guesstimating ovulation, people will use our Ovulona monitor.

More details are in the attached file: Fetal sex preselection – illustrated

The file is a description of the origin (including the best clinical trial evidence available to date) of the 3-day fertile window.

The 3-day window of high conception probability is unequivocal (there is no doubt that the data show that window). The low birth counts on the flanks of this 3-day group are data point outliers due to errors in the investigators’ estimating the ovulation day.

The 3-day group of high birth counts is in the data whether we simply ignore the outliers or add them to this group. This is no unreasonable massaging of the data because the investigators’ methods of estimating ovulation timing are well known to have high error bars associated with their ovulation-day estimation.

The 3-day fertile window is also supported by evidence published in the NIH paper referenced below. The 3 days of unequivocally high probability of conception are clear in their data, which is all based on analysis of first morning urine samples for metabolites of estrogen and progesterone that they considered “highly concordant with the peak urinary concentration of luteinizing hormone (which corresponds approximately with the day of ovulation)”.

The NIH researchers (Wilcox et al.) did not consider the inaccuracy of their estimated ovulation despite their having acknowledged that their method only “approximately” assessed the timing of ovulation. Unlike France et al., they did not use more than the one method of estimating ovulation. They simply accepted that, in addition to the three days of high conception probability, their data also contained three early days of low probability of conception – as though 3 to 5 days old spermatozoa made a woman a little bit fertile, despite the 3-day maximum lifespan of the sperm.

We account for their days of low conception probabilities in the same way as above, in terms of data point outliers. A probable cause of their low conception probabilities in the early pre-ovulation days (days -5 to -3), additional to their merely approximately estimating ovulation timing, was the possible delay between the indirectly monitored systemic hormone signals and the actual ovulation. Ovulation (day 0) in their study was not detected but only assumed based on urine hormone metabolite measurements. Despite this and other flaws in their study design, the evidence of the 3 days of high conception probability is there, similar to the data of France et al.

The Wilcox et al. technique of tracking certain ovarian hormones in the urine does not monitor the complex mechanism of folliculogenesis. Any mismatch between the ovarian and the brain hormone signals goes therefore undetected, and their estimate of ovulation timing is indeed very approximate. Of the other study design flaws, let’s mention the artifice that any “intercourse recorded on a given morning was assumed to have occurred the previous day”. This incongruous assumption artificially produced the day 1 conception probability of zero.

As for their low probability data for days -5 to -3, we can consider them to be data point outliers because a pilot study with our prototypes produced evidence of ovulation delays of up to 3 days after urinary LH detection (even 4 days in one of the 21 cycle records, monitoring urinary LH, Peak mucus, and Ovulona prototype). Ref.: https://biozhena.wordpress.com/2010/03/28/folliculogenesis-in-vivo%E2%84%A2-monitoring-is-far-better-than-current-home-use-fertility-self-help-tools/

Further, in support of the fetal gender preselection based on fertilization timing, a “statistically significant lower proportion of male births among conceptions that occur during the most fertile time of the cycle”, meaning at or near estimated ovulation, was found in a 1991 Johns Hopkins University meta-analysis of six NFP studies, cited below in the References.

Similar conclusion came out of an assessment of medical literature in 1989: “More females are conceived when coitus occurs relatively close to ovulation…”. The view of the cited group at University of Washington School of Medicine, Seattle was that the “influence of coital timing on the sex ratio is overall quite subtle and is not a practical method to alter the sex ratio for individual couples” (for citation see References). We would say that our purpose is to offer a means with which to make it practical…

Besides the referenced reviews of clinical outcomes, there is the above-mentioned evidence from a premier infertility treatment institute (G. Hodgen et al., see References) that male spermatozoa (Y-chromosome-bearing sperm) live longer than female spermatozoa (X-chromosome-bearing).

Therefore, intercourse two days before ovulation favors the conception of a boy because only the male Y-chromosome bearing spermatozoa live that long. The male sperm live long enough to be available for fertilization when ovulation releases the ovum (egg) from the ovulating ovarian follicle.

Whereas the female X-chromosome bearing spermatozoa have a chance to produce a baby girl only if intercourse takes place on the day of ovulation, because of their short lifespan.

Note that these are probabilistic indications, hence the labeling “try for a boy” and “try for a girl”. Certainly, we would not say that on the given day you will definitely conceive as indicated.

That should be no surprise because you know that conception is a matter of chance, a probabilistic matter, in the first place. More on this topic of conception probability is in the post Difficult conception tied to pregnancy complications – addressed.

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References

France et al. paper with data on fetal sex pre-selection, 3-day fertile window:

J.T. France, F.M. Graham, L. Gosling, P. Hair and B.S. Knox, “Characteristics of natural conception cycles occurring in a prospective study of sex preselection: fertility awareness symptoms, hormone levels, sperm survival, and pregnancy outcome”, International Journal of Fertility 37 (4), 224 – 255, 1992.

Wilcox et al. NIH paper:

A.J. Wilcox, C.R. Weinberg and D.D. Berg, “Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby”, New England Journal of Medicine 333, 1517 – 1521, 1995.

Hodgen et al. paper on different survival times of X and Y sperm:

Q. Van Dyk, M. C. Mahony and G. D. Hodgen, “Differential binding of X- and Y-chromosome-bearing human spermatozoa to zona pellucida in vitro”, Andrologia, Volume 33, Issue 4, Page 199, July 2001.

Johns Hopkins University meta-analysis of six NFP studies:

R. H. Gray, “Natural family planning and sex selection: fact or fiction?”, American  Journal of Obstetrics and Gynecology 1991 Dec; 165(6 Pt 2):1982-4.

University of Washington School of Medicine review and assessment:

P. W. Zarutskie, C. H. Muller, M. Magone and M. R. Soules, “The clinical relevance of sex selection techniques”, Fertility and Sterility 1989 Dec; 52(6):891-905.



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