Posts Tagged ‘vaginal’

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

July 10, 2011

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

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

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

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

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

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

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

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

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

Preparing the execution of Jan Hus

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

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

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

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

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

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

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

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

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

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

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

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

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

Alphonse Mucha: Madonna Of The Lillies

Alphonse Mucha: Madonna Of The Lilies

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

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

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

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

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

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

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

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

Did not receive any, unfortunately.

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

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

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

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

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

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

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

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

Alfons Mucha, Malířství

Alfons Mucha, Malířství

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

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

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

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

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

But does anyone hear this?

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

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

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

Is this a heresy?

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.

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.

Cervix uteri and seven or eight related things

December 16, 2007

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

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

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

Cervix:

The narrow lower part of the uterus (womb), with an opening that connects the uterus to the vagina. It contains special glands called the crypts that produce mucus, which helps to keep bacteria (and other microbes, including sperm for most of the cycle) out of the uterus and beyond. Sometimes called the neck of the womb, it protrudes into the vagina. The region around the cervical protrusion is known as the vaginal fornix. The sanitary vaginal tampon is inserted so as to reach into the posterior fornix. Likewise the bioZhena sensor. As simple as that.

The cervix is the gateway to the uterus and has a lot of important and challenging roles. It must allow the passage of either sperm (or penis, in some species) at copulation, prevent the entrance of microorganisms before and particularly during pregnancy, and expel the neonate and placenta at parturition (birth). It is a muscular tube that has a very dynamic role in both the menstrual cycle and in forming a tight seal during pregnancy, but opening to form a broad passageway at birth. The multitude of physiological roles of this gateway has caused it to become an important element or focus of the bioZhena technology.

Cervical mucus:

The fluid secreted by the inner walls of the cervical canal and exuded by the cervix. The amount and the properties of the fluid change depending on the phase of the menstrual cycle, e.g., from practically nonexistent during the so-called dry days early in the cycle to the relatively copious amounts of clear slippery fluid during the fertile days.

Cervical mucus is essential for the ability of the sperm to function properly: sperm survival and sperm transport within the woman’s reproductive system are critically dependent upon the presence of a healthy mucus.

To quote a noted expert, Professor Erik Odeblad: “Complications arising from the use of the Pill are very frequent. Infertility after its use for 7-15 years is a very serious problem. S crypts are very sensitive to normal and cyclical stimulation by natural oestrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced. Treatment is difficult.” He also wrote: “After 3 to 15 months of contraceptive pill use, there is a greater loss of the S crypt cells than can be replaced … A pregnancy rejuvenates the cervix by 2-3 years, but for each year the Pill is taken, the cervix ages by an extra year.” Web reference:http://www.billings-ovulation-method.org.au/act/pill.html .

Cervical mucus method:

A method of determining a woman’s fertility by observing changes in her cervical mucus. The Billings ovulation method and the Creighton model ovulation method are both cervical mucus methods.

Cervical palpation:

Feeling the cervix with the middle finger of the thus trained woman-user of FAM or NFP to determine cervical position. This is not a widely used procedure, and is not involved in the Billings and Creighton ovulation methods.

Cervical position:

Three facets of the cervix (its height, softness and the size of its opening, the cervical os) assessed for fertility significance by specially trained users of this method of NFP or FAM. Not many of those around…

Colposcope:

A viewing instrument with a bright light and magnifying lens that is used to examine the vagina and cervix stained with special solutions. Colposcopy: Examination of the vaginal and cervical epithelia by means of a colposcope. [Greek kolpos, vagina, womb + -scopy, suffix that signifies viewing; seeing; observation: as in microscopy. From Greek -skopi, from skopein, to see.] Colposcopy is the diagnostic procedure to evaluate patients whose Pap smear screening produced abnormal cytological smear results.

Billings Ovulation Method (BOM):

An NFP method in which the fertile days are identified exclusively by observations of cervical fluid at the vaginal opening. Developed by the Australian Drs. John and Evelyn Billings. An international survey in 1987 indicated that at least 50 million couples were using the method, and the number is said to be increasing from year to year. It has also been estimated that 80% of natural family planning world-wide is now the Billings ovulation method. In 1978 an international conference in Melbourne was attended by delegates from 48 countries. See also the cervical mucus method.

Creighton model ovulation method:

An NFP method of vaginal-cervical mucus self-evaluation according to criteria developed by Thomas Hilgers, M.D. at St. Louis and Creighton Universities. The criteria are called the vaginal discharge recording system (VDRS) and require that women check for the mucus by wiping the outside of their vaginas with bathroom tissue, checking the mucus for color, stretch and consistency. The last day of mucus that is either clear on appearance, stretches an inch or more, and/or causes the sensation of lubrication is called the peak mucus day. The method is similar to the Billings ovulation method.

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bioZhena’s method of monitoring the cervix:

And then we have the bioZhena method, with the Ovulona inserted briefly just like a tampon applicator, and taking a reading of the fertility status (most of the time NOT FERTILE = cannot conceive; only 3 days of fertility in each menstrual cycle):

Ovulona™

The DIU is or will be an auxiliary add-on

 

 How the Ovulona will be transformed into a (semi-) permanently worn cervical ring obviating daily insertion is shown in slide 4 of QUICK INTRO 4 SLIDES at

Friendly Technology and Next Generation Design

The natural interest of women in being in charge of their reproductive life leads to the possibility of using the information gathered in the process for additional medical purposes. The Ovulona cyclic profile is the signature of the menstrual-cycle vital sign, which is the result of the illustrated interaction between the female brain and the ovaries – the so-called Hypothalamus-Pituitary-Gonad Feedback Loop (F). (This editing added here in 2016.)

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 captured by the bioZhena technology.

Here is why the bioZhena technology had to be invented. One way of saying this is: The available means, methods or products, were not good enough. Another way of putting this is to quote from medical literature, as follows.

A symposium on ovulation prediction in the treatment of infertility covered all the phenomena known to be associated with ovulation [reference 9]. Moghissi, who discussed more than 20 measurable parameters that vary during the menstrual cycle, stated the following [reference 8]: “Mid-cycle mucorrhea, ferning, spinnbarkeit, lowered cell content, and viscosity of cervical mucus are used commonly in ovulation detection and as an index of the estrogenic response of cervical epithelium. However, these changes extend over several days … (These changes) do not necessarily indicate ovulation, and are merely an index of the optimal amount of circulating estrogen…”.

In brief, none of the methods determined ovulation with the required accuracy to be useful either as a conception aid or especially for birth control. Here is how our method (monitoring folliculogenesis) does it by generating the multi-featured cyclic profile that includes the definitive ovulation marker after the predictive signals, and here is how this compares with the older techniques. See how inaccurate is the ovulation assessment by the older means available to the users of NFP or FAM (spread over 3 days):

Marquette comparison with LH kit and Peak mucus – right click on the link to open a larger PDF version of the image.

Marquette comparison with LH kit and Peak mucus

In this example, our device detected delayed ovulation while the LH ovulation kit indicated positive for ovulation on two days (not just one) and the mucus assessment (Creighton method) indicated positive one day later. The LH was positive the day before as well as on the day of the ovulation marker (day 17), while the Peak mucus day indicated ovulation one day after the ovulation marker day.

The spread of 3 days is not acceptable, but it is actually quite typical of the uncertainty associated with these older techniques. You know what that means, don’t you, because you know that every day matters. Their lack of accuracy and precision renders the older techniques not good enough – which is where we started.

Cited references:

[8] Kamran S. Moghissi, “Cervical mucus changes and ovulation prediction and detection”, Journal of Reproductive Medicine 31 (Number 8), Supplement, 748 – 753, 1986.

[9] Stephen L. Corson, guest editor, “Ovulation Prediction in the Treatment of Infertility. A Symposium”, Journal of Reproductive Medicine 32 (Number 8), Supplement, 739, 1986.

Review and listen to 3 narrated slides summarizing the bioZhena technology. Contemplate the importance of the cervix uteri.

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 Ovulona™

December 11, 2007

This is the putative trade name of the women’s health version of the bioZhena core product, as opposed to the animal version (see the BioMeter entry in the Alphabet of bioZhena). An earlier prototype was once referred to as the Ovulon – at the time when it received its FDA 510k clearance – but the feminine-gender form of the name is surely more appropriate (with the a at the end of the name, the Ovulona).

Now a citation:

A remarkable property of the cervix is the extreme sensitivity to the effect of estrogen and progestogens. Changes in the composition and properties of cervical secretions have been used for many years as an in vivo biologic assay for sex steroids.

How well put, on page 564 of the compendium “Human Reproduction: Conception and Contraception”, edited by E.S.E. Hafez and T.N. Evans, Harper & Row Publishers, 1973.

In the Epilogue, Professor Hafez further stated that “…the fertile period of the menstrual cycle is not more than 4 days, and probably less”.

He also said: “Unfortunately, accurate detection of this fertile period is difficult, due to individual variation in the length of the menstrual cycle and frequency of ovulation, and to the absence of clinical signs of ovulation.”

We cite him here because the books edited by Hafez were explored at the inception of this project, and because all these referenced facts of life were the premises for the beginning of the project and for the development of the intellectual property.

You may almost view the cited reference to the remarkable property of the cervix as a possible definition of the bioZhena innovation. Definition of the basic primary application of the invention. Accurate detection of the fertile period is the operative phrase, and it is what eludes the various alternative, already marketed, methods and products. I refer to them as the peri-ovulation methods. We all know that those products have not solved the fundamental diagnostic need of woman- or humankind. 

We have, which is why we can talk about a non-hormonal, non-chemical, non-barrier, non-surgical pregnancy avoidance as well as pregnancy aiding – by timing intercourse with respect to ovulation. Here is a schematic diagram of how (stripped of precision):

The essence of bioZhena’s primary product offering

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For more on how this will work for you, view the slide The three-day fertile window how-to (to exit the slide, just click on it. You can also view this by clicking on the image below).

In this animation, with the “try for” indicators, we reference the outcome of a France et al. study of fetal gender pre-selection superimposed on the menstrual cyclic profile generated by our device in a small clinical trial. Morning and evening monitored data were compared to BBT temperature data of the same subject of the pilot study. You might notice how the data suggests the progress of folliculogenesis between the AM and the PM hours.

Fertile windowClick image to view The three-day fertile window how-to (to exit the slide, just click on it).

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And now, let me insert a fast-forward from the time this post was written in December 2007.

Here is the shortest possible summary introduction of the Ovulona device for women’s personal tracking of fertility with concurrently screening cervical health. 3 slides with some links https://biozhena.files.wordpress.com/2018/03/ovulona-from-startup-version-to-cervical-ring-implementation.pps

For further particulars, try this bioZhena intro in 10 mostly narrated slides https://biozhena.files.wordpress.com/2016/12/new-set-v7-narrated-slides-edec16.pps

How the OvulonaTM will help women’s physicians to better help their patients is shown in this slide: https://www.linkedin.com/feed/update/urn:li:activity:6489235834502463488

Cervical health screening, pregnancy monitoring and other applications will be introduced while generating revenues with the already FDA-cleared minimum-value application of the core OvulonaTM product.

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The Smart Ovulona™ will interpret the daily measurement data for display on the screen of the device in plain language such as FERTILE DAY 1 or PREGNANCY DETECTED or SEE DOCTOR ABOUT CERVIX.

But that is only the beginning. The fertile window determination is the basic or primary application of the Ovulona, our core product with numerous diagnostic ramifications within the bioZhena Fertility and Health Awareness System™.

The various topics for utilization of the Ovulona are discussed in the posts of this blog, reflecting the broad applicability of our technology of FOLLICULOGENESIS IN VIVO™ beyond reproductive management. See, for example, Much in women’s health revolves around folliculogenesis – from teen age to peri-menopause .

Although we do not disclose and I do not blog about all the significant uses of at-home monitoring of the cervix uteri, another example is discussed in the post “Far more than a tool for getting pregnant and for pregnancy avoidance. (On symptometric monitoring correlated with folliculogenesis: Why it is essential for effective diagnosis in women’s healthcare)”. This is a hint at how the technology can help physicians to better help their female patients.

Explore the blog’s Table of Contents. In one of the articles you will read how another Emeritus Professor (Erik Odeblad) influenced the inception and development of the bioZhena project by his work, which influence was memorably captured in his apt saying,

“The cervix is a precision organ as complex as the eye”.

There you have it, the basic tenets of bioZhena and our focus on the cervix uteri.

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For further particulars, read on.

The origination of the Ovulona (and/or BioMeter) technology was a response to a basic human need on the part of a husband and wife pair of scientists. On the one hand, we struggled with the newly experienced pain of an apparently sterile marriage. But we also realized that we were conceivably in a position to help ourselves by combining our respective professional knowledge resources.

It all goes back to the postulate, by the ever so pragmatic female of the species, that before any of the more or less bothersome medical procedures should be undertaken, the basic problem of proper timing of the conceptive intercourse (i.e. of insemination) must be conquered.

This is how the project came about, and everything else followed. (The reader will understand that the postulated principle holds for every couple.) And let’s be explicit about the fact that “everything else” includes not only the broad applicability of the ensuing tissue biosensor.

The said “everything else” also includes the realization that, by interfacing with the cervix, we are monitoring folliculogenesis (the maturation of the egg in the ovarian follicle). And it includes, most importantly, the crucial capability to detect ovulation and not just predicting it. Last but not least, “everything else” also includes the appreciation of the unprecedented impact the monitoring of fertility status via the uterine cervix has on the quality and broad applicability of the menstrual cycle profile.

Better than so many words, let me offer you a picture, a shorthand representation of what the bioZhena ectocervix monitor is involved with, how the menstrual cycle profile records come about – the neuroendocrinological mechanism. Do note well the words in lieu of the figure caption.

Hypothalamus-P-G Feedback and innervation panorama

Here are 447 words in lieu of a caption for the composite image:

The ovulographic monitoring of folliculogenesis in vivo is believed to capture the fine-tuning effects on folliculogenesis of the direct neural control via ovarian and uterine innervation and the acute effects of local (autocrine and paracrine) modulatory actions.

Neither of those effects can be detected by the systemic peripheral variables such as the BBT or the urinary levels of hormones monitored by the commercially available home-use technologies.

See https://biozhena.files.wordpress.com/2019/01/Single-slide-How-the-Ovulona-will-help-physicians.pdf for how this will help physicians to better help their female patients. See how Ovulona anticipates failure to ovulate in a healthy woman, and how Ovulona detects delayed ovulations in asynchronous cycles that happen to many healthy women. These occurrences are where the neurological effects are suspected to play a role.

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Although we could not really be clear about this until Chiara Benedetto, M.D. sent us the results of measurements performed with our early prototypes by her carefully selected baseline subjects, the Ovulona provides not only a short-term anticipation of ovulation but also an earlier long-term prediction signal.

This was subsequently confirmed by another proof-of-concept study with non-baseline subjects at the Natural Family Planning clinic at Marquette University (Wisconsin – Dr. Richard Fehring and associates). See the Fehring and Schlaff paper with a Note about further insight into the published results.

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Three baseline cycles from Turin clinical trial

The cyclic profile features are discussed in the Post Script, below.

To be clear, the long-term predictive peak has no counterpart among the various other methods of fertility monitoring. Its position ahead of ovulation apparently depends on the rate of maturation of the dominant follicle in the given menstrual cycle, and it correlates with the length of the menstrual cycle.The other methods predicting ovulation all monitor hormone markers in general circulation (after clearance into other body fluids), which is too remote, indirect, hence the no counterpart statement of fact.

None of this would have been apparent from the early in-house longitudinal study, since the study involved a non-baseline subject (and then another). In non-baseline cycles, which are common in real life, even the luteal (post-ovulation) phase quite often is not the theoretical 14 days long… and various other deviations occur from the “ideal” (simplified) case descriptions found in medical textbooks.

Data to date indicate that the long-term warning of the upcoming ovulation event occurs sufficiently early for the practice of natural family planning (NFP). Consequently, we are in a position to claim progress over the 1973 statement in the Hafez Epilogue, which stated that “the long-term prediction of ovulation by at least 6 days seems to be difficult and, as yet, unsolved” (loc. cit. page 711).

The capability to anticipate ovulation well in advance, and to then detect ovulation independently of the predictive signals, is unique to the bioZhena technology.

This unique capability results from the mode of action, further discussed in the Alphabet of bioZhena under Modus operandi (MO). See also under Mysterious conceptions – or the non-existence thereof. From the MO also follows the broad applicability of the technology.

This broad applicability is another feature that distinguishes the Ovulona from any other product addressing fertility status and, as they in fact do, merely estimating (guessing at) ovulation.

For a potential impact of the technology on public health, see in the Alphabet under Sexually transmitted diseases, and also under Cervical cancer and under Smoking. You can also find articles on these topics in this blog’s Table of Contents (TOC). The TOC is clickable and provides descriptive snippets about the blog articles. As an example, see the blog post “Smoking affects the menstrual cyclic profile as captured by the Ovulona™, monitoring might help with smoking-cessation” .

It could be argued that the greatest aspect of the bioZhena project is the idea of introducing – via the affordable personal fertility monitoring method – a general, routinely usable, women’s health tracking and diagnostic tool, with the potential to impact on several important areas of public health. We have every intention to make this argument, and we plan to put it into practice – with support of a well-matched investor. That is why the plan to transform the Ovulona into the (semi) permanently worn telemetric cervical ring.


Post script

Here is a larger, easier to read, rendition of the Figure with the data (choose either a silent graph or a narrated animation):

Three baseline cycles from Turin study and/or the same as an annotated slide narrated by yours truly

The cyclic pattern exhibits a number of well defined peaks and troughs: The first repeatable feature is the first post-menstruation minimum occurring typically on day 6, 7, or 8 (driven by the selection of the dominant follicle). The signal then rises to a maximum (the long-term predictive peak), which is driven by the maturation of the dominant follicle.

At this point I share with you the explanation of the long-term predictive peak by reference to the picture of the baseline cycles that we are now well familiar with. The picture is annotated with labels and short-hand elucidation of the features under discussion.

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For better legibility, click the image, view a slide show version.          The URL is: https://biozhena.files.wordpress.com/2016/12/wealth-of-info-elucidation-of-domin-folli-peak-3-slides.ppsWealth of information and elucidation of DF peak

 R… Recruitment on days 1 to 5 ± 1 (data captured usually only after blood flow – due to hygiene concerns).

S… Selection on day  6 ± 1.

GC+TC E2up… Dominant Follicle Maturation: Granulosa and Theca Cells produced Estradiol  (E2) rises, which drives the signal up; Dominant Follicle also initiates expression of LH Receptors.

GC P4up… After the appearance of LH Receptors, the preovulatory Granulosa Cells secrete Progesterone (P4), which drives the signal down. (That’s also why the ovulation marker is a trough, the lowest minimum in the menstrual cyclic profile.)

Ref.: Page 39 of 23rd Edition of Williams OBSTETRICS © 2010, 2005, 2001 by The McGraw-Hill Companies, Inc. (www.gums.ac.ir/Upload/Modules/Contents/asset39/williams23.pdf)

Above: Elucidation of the long-term ovulation-predictive dominant follicle peak (December 2016)

The long-term predictive dominant follicle peak is followed by the usually narrow short-term predictive peak, which falls off directly into the trough of the ovulation marker, the lowest reading of the cycle. We have found the ovulation-marker minimum to correlate with urinary LH and FSH peaks, and we view the marker to be an effect of the steroid hormone switch that occurs at ovulation (estrogen to progesterone dominance).

Note that the corresponding basal body temperature (BBT) curve rises, to the post-ovulatory higher level, after the ovulation marker. This indicates, to the extent that the BBT can be relied on, that ovulation had, indeed, occurred. The planned sonographic (ultrasound) investigations will confirm this correlation with a better accuracy.

The post-ovulation (luteal phase) peaks and valleys have only recently been interpreted as due to the follicular waves (preparing for the next menstrual cycle). The follicular waves are a relatively recent discovery in women [Baerwald AR, Adams GP, Pierson RA, Fertil. Steril. 2003 Jul;80(1):116-22, “A new model for ovarian follicular development during the human menstrual cycle”], which now adds a diagnostic usefulness to the luteal-phase part of our cyclic profile – for example re: menopause, aging, which is a use of the waves invoked by the cited authors.

Our understanding of the implication for early detection of pregnancy came in due course. Very early detection, essentially instant – no waiting for two weeks for the absent menstrual bleeding and for a detectable concentration of hCG in the urine!

See https://biozhena.wordpress.com/2010/11/11/instant-detection-of-pregnancy-and-of-early-pregnancy-loss-epl-the-adversary-of-trying-to-conceive-ttc-especially-after-age-25/ for the article “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

Early Pregnancy Loss (EPL) is also known as stillbirth or miscarriage, or early embryonic mortality, and the Ovulona™ will enable the user to try conceiving again as soon as possible, in order to avoid recurrent EPL miscarriage (since it is now known that the sooner conception occurs after the EPL, the better the chance of success).

Should you wish to talk with me on the phone or via Skype, please email me first to schedule the call. My email is: vaclav at biozhena dot com

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BIOZHENA’S MISSION: A HEALTH TOOL FOR EVERY WOMAN

December 10, 2007

Far more than a tool to aid achieving and avoiding pregnancy

In the early years of the project, I published here a modestly formulated version of bioZhena’s vision statement. That was before a female OBGYN physician joined the team and together we broadened the vision and mission.

With the “Ambassador for the Vagina” it became plausible to fully explore the broad applicability of the technology, and to plan pregnancy monitoring and the transformation of the daily-inserted Ovulona into the semi-permanently worn telemetric cervical ring version that Kim the OBGYN named the Halo™.

Friendly Technology - with cervical ring & Ovulograph

For healthcare providers the Ovulograph™, and the Halo™ cervical ring for all women

Our vision is to create a product that practically every woman will want to use. The woman of the 21st century is envisaged to become accustomed to using her daily Ovulona and/or Halo self-check about as routinely as she is using her toothbrush.

It is pertinent to note that a May 2017 Human Factors in Computing Systems study found that the smartphone apps that track menstrual cycles “often disappoint users with a lack of accuracy… and an emphasis on pink and flowery form over function and customization”. Significantly, too, “teenage girls were relying on smartphone apps as their primary form of birth control”. Such evidence indicates that the market is primed for the bioZhena technology breakthrough.

The Ovulona™/Halo™ will be useful to the point of becoming an essential tool of women’s health management, both at home and, when appropriate, via the Ovulograph™, for the provider in the doctor’s office – and for the payer, too. Accordingly, the Ovulona will be supremely user-friendly and affordable for everyone.

See and listen to the slides in the link at the end of the post.

The Ovulona personal fertility status self-diagnosis device

 What is folliculogenesis - like EKG

Applications of cervical sensor girl w. device and other solutions - panorama1

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Go to New mostly narrated slides 2017

Slide show takes a few moments to open

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