Archive for the ‘blog’ Category

About Clomid, Serophene or, generically, clomiphene citrate. A critical look, part 1.

June 23, 2010

In relation to folliculogenesis, the mechanism of menstrual cycling, which we monitor in vivo – to get away from drugs as much as possible.

Last night I re-tweeted this:

RT @FertilAidAmy What is Clomid…? http://blog.fairhavenhealth.com/ = it’s NOT recommended to take it for >6 cycles, and it causes decreased fertile mucus

Then I found that there is no entry about Clomid in the Alphabet of bioZhena. Yet, Clomid is a very frequently administered medication for women with difficulty conceiving, “prescribed to women that are trying-to-conceive to induce ovulation. Clomid is often prescribed to women with irregular cycles that either experience irregular ovulation or don’t ovulate at all” (http://blog.fairhavenhealth.com/ ).

30% of women or couples cannot get pregnant

Clomid was also involved in a peculiar episode when a business-incubator director took me once to a local hospital’s young lady gynecologist thinking that, because she was written about in the local newspaper, she was just right for bioZhena Corporation’s quest for good people and/or “strategic allies”. Instead, the take of the young physician, who took several calls from upstairs during the “interview”, was something along the lines, “I don’t see what’s in it for me with your technology. When they [subfertility sufferers] come to us, we put them on Clomid, and that’s that…”.

dali - longlegs_large

Dali - Longlegs

Well, let’s look at what the “that’s that” is about. The referenced tweet mentioned, within the allowed 140 characters, two features. One, that Clomid should not be taken for more than 6 menstrual cycles. And two, that it is known to reduce the amount of the all-important fertile mucus, which is the cervical mucus form occurring only during the run up to ovulation. This essential temporary change is for the purpose of opening the cervical canal for the penetration of the sperm and, in fact, for what is called the capacitation of the sperm. At all times outside of the fertile window, the fertile mucus is replaced by the protective type of cervical mucus, which prevents the entry of microbes including sperm into the uterus and beyond.

For a concise overview of this essential mucus, read the article Cervical mucus (under C) in the Alphabet of bioZhena, at  https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf . There we cite a noted expert on the subject, Dr. Erik Odeblad, and the gist of his message is: “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 estrogens, and the Pill causes atrophy of these crypts. Fertility is impaired since the movement of sperm cells up the canal is reduced.”

You can imagine that this will have something to do with the reason why the woman becomes a patient and is now prescribed the fertility drug.

One other thing about the drug is the issue of the official “10-per-cent possibility that Clomid could produce twinning”, described by a physician’s blog post at KevinMD.com about “one of the largest malpractice awards in Canadian history. At issue is how the patient understood the discussion of the risks of Clomid”: http://to.ly/5cE7 .

Sublime moment by Salvador Dali, 1938

Sublime moment by Salvador Dali

Clomid is the brand name for the fertility drug clomiphene citrate. Clomiphene citrate may also be sold under the brand name Serophene or as the generic version called clomiphene citrate (http://to.ly/5cIc ).

Here is a bit more scientific take on how it works, cited from Wikipedia (http://en.wikipedia.org/wiki/Clomifene ):

Therapeutically, clomiphene is given at day 2 of menses [menstruation]. By that time, FSH level is rising steadily, causing development of a few follicles [in the ovary].

Let’s interject a clarification: This timing is called the recruitment stage of folliculogenesis, during which LH induces an “angiogenesis” factor from the theca cells, increasing the blood supply and estrogen synthesis by the recruited cohort of follicles.

The term “selection” indicates the reduction of the recruited group of follicles down to the species-characteristic ovulatory quota, which in women and related primates is one. Selection is the culmination of recruitment on day 6 ± 1. “Typically only one of the two ovaries sponsors recruitment and selection of the single dominant follicle, which is destined for ovulation.” We detect the selection stage as the first marker in our ovulographic™ (or folliculogenesis in vivo™) cyclic profile. Refer to the bioZhena tech pitch page http://to.ly/xE6 and/or to http://to.ly/MJU , http://to.ly/MWl .

Back to the language of the Wikipedia article: Follicles in turn produce the estrogen, which circulates in serum. Clomiphene acts by inhibiting the action of estrogen on the pituitary [gland, or hypophysis, in the brain]. [It] binds to estrogen receptors and stays bound for long periods of time.

This prevents normal receptor recycling and causes an effective reduction in hypothalamic estrogen receptor number. As a result, the body perceives a low level of estrogen… Since estrogen can no longer effectively exert negative feedback on the hypothalamus, GnRH secretion becomes more pulsatile, which results in increased pituitary gonadotropin (FSH, LH) release. Increased FSH level causes growth of more ovarian follicles, and subsequently rupture of follicles resulting in ovulation. END OF QUOTE.

Dali - Geopoliticus Child Watching the Birth of the New Man (1943)

Salvador Dali - Geopoliticus Child Watching the Birth of the New Man

From another Wikipedia article, about GnRH (http://en.wikipedia.org/wiki/GnRH ):

At the pituitary, GnRH [Gonadotropin Releasing Hormone (synthesized and released from neurons within the hypothalamus )] stimulates the synthesis and secretion of the gonadotropins, (that is) follicle-stimulating hormone (FSH) and luteinizing hormone (LH). These processes are controlled by the size and frequency of GnRH pulses, as well as by feedback from androgens and estrogens. Low-frequency GnRH pulses lead to FSH release, whereas high-frequency GnRH pulses stimulate LH release. …the frequency of the pulses varies during the menstrual cycle, and there is a large surge of GnRH just before ovulation.

To reiterate, Clomiphene acts by inhibiting the natural action of estrogen on the pituitary gland in the brain, interfering with – or, shall we say, altering, manipulating – the process of folliculogenesis. Women’s health revolves around folliculogenesis and its complex control mechanism by the brain and by the ovaries.

To give you a sense of said complexity of the biology we are working with when we monitor folliculogenesis in vivo, we cite the specialist, Dr. Ernst Knobil: “The mechanism is believed to involve the circhoral* clock of the hypothalamic GnRH pulse generator, on which the circamensual** ovarian clock is obligatorily dependent”. [*Occurring cyclically about once an hour, pulses from the brain; ** about once a month.] From Knobil’s memorial lecture The Wisdom of the Body Revisited, available online at http://physiologyonline.physiology.org/cgi/content/full/14/1/1 .

Sleep by Salvador Dali, 1937

During the reproductive years, pulse activity is critical for successful reproductive function as controlled by feedback loops. Cited in conclusion from the Wikipedia GnRH article referenced above. (The Wikipedia also has an article about the cervix and cervical mucus, at http://en.wikipedia.org/wiki/Cervical_mucus#Cervical_mucus .)

15- Word(le) greetings from bioZhena's follicular waves

15- Word(le) greetings from bioZhena's follicular waves

A wordle is a toy for generating “word clouds” from text.

In this case the entire bioZhena’s Weblog as it was in November 2009 — 15 most prevalent words.

It is advisable – and safer – to go about TTC, Trying To Conceive, without the use of chemicals, especially man-made chemicals, and note that herbal preparations are chemicals too. Monitoring (measuring) the effects of anything you ingest is basically a must, if you do not play “Russian roulette” with yourself, your offspring, your family.

The above wordle, the “greetings from bioZhena’s follicular waves”, is a reminder that, before resorting to the chemical route, the innocuous “right time” approach is indicated (because it does not go against – it goes with – the natural biology of the body).

Have you noticed that the powerful Clomid is an estrogen agonist/antagonist? (Acting like estrogen or against estrogen. Tricky, yes? You bet. Or play roulette…)

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Comment on Female sexual dysfunction treatment options

June 20, 2010

An excellent overview post appeared on the KevinMD.com blog, titled Female sexual dysfunction treatment options, written by Jill of All Trades, MD: http://www.kevinmd.com/blog/2010/05/female-sexual-dysfunction-treatment-options.html .

It is worthwhile to capture the introductory paragraphs of Jill’s post here:

Female sexual dysfunction has been reported in up to 40% of women, and described as causing actual distress in approximately 12% of women.

Michelangelo The Last Judgment, 2 cropped

Michelangelo, The Last Judgment, 2 cropped

Therefore, it is an important topic to familiarize with and screen for as a primary care physician, as many patients may not report these symptoms unless they are elicited during the history taking process of the patient encounter. Female sexual dysfunction is often multifactorial and complex; it is affected by such factors as depression and anxiety disorders, life stressors, interpersonal conflict between the couple, medication side effects, age, religious concerns, personal health, privacy issues, personal body image, substance and alcohol abuse, and hormonal influences.

In order to understand the necessary treatment options, it is important to understand the normal female sexual cycle. There are four phases:

1. Libido: the desire for sexual intimacy, through images or thoughts.

2. Arousal: the increase in heart rate, blood pressure, and respiratory rate, along with increased genital blood flow.

3. Orgasm: the peak of sexual pleasure, with rhythmic contractions of the pelvic muscles.

4. Resolution: the return to baseline with pelvic muscle relaxation.

Michelangelo The Last Judgment

Michelangelo The Last Judgment

The author then very nicely and concisely reviews the treatment options.

I posted the following comment, which at this writing was “awaiting moderation”. –

Thank you for an excellent overview.

I envisage that our Ovulona™ personal vaginal monitor (https://biozhena.wordpress.com/2007/12/11/the-ovulona™ ) will do two useful things for peri-menopausal women and their physicians (https://biozhena.wordpress.com/2008/10/06/ovulona-is-not-another-ovulation-kit ):

#1. Detect effect of any treatment on vaginal tissues and thus allow for personalization of therapy, titration of medications); and

#2. Allow vaginal delivery of therapeutic compounds.

The Ovulona should become a friendly companion tool for all women, to be routinely used from adolescence to peri-menopause (not only for reproductive management, its primary – or certainly initial – purpose).

Ref.: https://biozhena.wordpress.com/2007/12/18/menopause-hrt-and-biozhena/

Regards,

@bioZhena

Michelangelo, The Last Judgment, 2

Michelangelo, The Last Judgment, 2

To this, for the purpose of bioZhena’s Weblog, I would add a reminder about the significance of the problem of (tissue) atrophy, which the reader will find in The Alphabet of bioZhena (under A in the article titled Atrophy) at https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

Atrophy means a wasting away, deterioration, or diminution, any weakening or degeneration (especially through lack of use). Read the article, you’ll see about genitourinary atrophy that leads to a variety of symptoms (in both sexes), affecting the quality of life.

And more, including about “estrogen therapy, which is invariably successful in reversing the atrophic problems. Relief from these problems often results in significant improvements in general well-being.”

In my comment above, #1 (detect the effect of treatment on vaginal tissues), the need for personalization of estrogen therapy is reflected, which requires the end-organ effect measuring tool that we provide. See also under E for End-organ effect in the Alphabet of bioZhena at https://biozhena.files.wordpress.com/2007/11/aaee-the-alphabet-of-biozhena.pdf .

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

March 23, 2010

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

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

Michelangelo - The Drunkenness of Noah

Michelangelo – The Drunkenness of Noah

Excerpts from their first study:

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

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

BBT + mucus                                    5/76                     7%

Monitor + mucus                               4/69                     6%

Mucus only                                       1/29                      3%

BBT + mucus + monitor                     2/25                      8%

Monitor only                                      0/5

Second study excerpts:

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

Monitor + mucus                          28/313                        9%

Mucus only                                  41/315                        13%

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

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

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

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

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

Wassily Kandinsky - Little Words

Kandinsky – Little Words

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

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

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

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


Michelangelo - The Battle of Cascina

Michelangelo – The Battle of Cascina

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Salvador Dali - Metamorphosis of Narcissus

Salvador Dali – Metamorphosis of Narcissus

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

The most succinct word about all this is as follows:

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

STOP PRESS

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

A few more peri-vernal equinox tweets on #conceiving, #fertility, achieving #pregnancy & #baby gender contrary to Shettles

March 21, 2010

While NFP users know that fertility awareness is a must for birth control

We all know that the peri in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology…”. We know that “peri” is in fact a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek, such as in the title here [http://dictionary.reference.com/browse/peri].

Peri - 1865

Peri - 1865

And now for the last few tweets; again somewhat edited, since here we do not have the 140 character limit. And again with clickable links to further information, including the #hash tags with all sorts of tweets there by anybody using a given hash tag, in the manner of the Twitter social networking mechanism.

These tweets should do it for this departure into the so-called microblogging. Do check out http://to.ly/VCF for what a reliable #fertility tool is about. Read up on it http://to.ly/vUz

Here is a birth control product that will be in the competition category when we go into the birth control market: http://twitpic.com/1971ez – This is the device used to insert the ‘Mirena’ coil into the patient’s uterus. Sent via TwitPic. Retweeted by you and 1 other. The reason why this was re-tweeted by yours truly was to highlight the invasiveness of the pictured device, which bears no comparison with ours (quite apart from our device not inserting into the uterus). But, of course, our product is not out yet, with all its user-friendly and otherwise beneficial attributes. Any comments, dear reader, would be appreciated.

RT@pregnancyorg: Read about your cycles getting #pregnant before #conceiving http://ow.ly/1l765 — and then I suggest you also read http://to.ly/VCF and http://to.ly/vUz

RT@Averyugya81: ARTs [Artificial Reproductive Technologies] for #infertility treatment may pass on genetic defects – warns ART pioneer http://to.ly/1pOJ . This is reminiscent of the development when Father of the Pill Dr. Djerassi turned against oral contraception, promoting instead what he called “the Jet-Age Rhythm Method”, by which he meant fertility awareness (aided by technology, hence the reference to jet age)

RT@Averyugya81: How often do I have to have sex to get #pregnant? http://to.ly/1pPi

Adam and Eve by Tamara de Lempicka - solarized

How often?

– Every day for 20 days with 69% chance of success, write statisticians http://to.ly/1phs (from day x to day y of your cycle)

If this continues to be pleasuresome, carry on for months on end to overcome the odds. Else, you need focus, and see my earlier tweets. Fight statistics! (With pleasuresome determination and with the aid of a deterministic timing tool… in the offing)

Again: The odds are against us! #pregnancy #birth control #fertility #startup angel-investor-find-and-match… same difference! Odds are very low (without that focus)

@pregnancyorg‘s gender selection http://to.ly/1qkx seems to perpetuate the Shettles recipe. However, evidence http://to.ly/1nyK http://to.ly/1qmz contradicts Shettles (whose claims have the reputation of not being backed by or based on any properly designed clinical studies). Here is a summary of a solid study, which – for the lack of “Perfect” – employed three “Imperfect Measures” of ovulation as defined in the previous post. The three gave similar results. Female births at (or near) ovulation, male births 2 days earlier (or so)

Birth distribution by gender - France et al., focused NFP TTC study

Birth distribution by gender - France et al., focused NFP TTC study

The uncertainty expressed by the “or near” and “or so” is the consequence of the “Imperfect Measures”, but the trend is clear. Also rather clear is that the low birth counts flanking the high ones are data outliers due to measurement errors inherent in “Imperfect Measures”. For more on this, go to the earlier post at https://biozhena.wordpress.com/2007/12/15/fetal-sex-pre-selection-%E2%80%93-the-fundamentals

Baby gender pre-selection will require a clinical study as stringent as the France et al. study was, but performed with our Ovulona instead of the inaccurate methods (BBT, Peak mucus, LH rise as opposed to LH surge apex)

Delville - Satan Treasures, 1895

Delville - Satan Treasures, 1895

RT@BabyMed: So can you get pregnant from having sex on your period? http://bit.ly/29yLQJ — THE absolute requirement is a RELIABLE #fertility monitor. (Persistent monitoring in the interest of evidence-based medicine)

RT@BabyMed: So can you get pregnant from having sex on your period? Yes, but only if the cycle is very short, which would be due to a very short follicular phase, which you can only detect with a RELIABLE monitor. (Not to track merely one, two or even three hormones in body fluids – you need to follow FIV™, Folliculogenesis In Vivo™)

RT@bioZhena RT@BabyMed: Furthermore, you want our built-in #pregnancy detection because it will see you #pregnant right away (not only about two weeks later), and – importantly – our device will also see if the pregnancy is lost, which happens quite frequently. See  https://biozhena.wordpress.com/2010/01/10/about-the-added-bonus-of-folliculogenesis-monitoring-automatic-pregnancy-detection . Early embryonic mortality is very high (according to some sources significantly more than 50%), and most of the losses of the conceptus occur early on, prior to 12 weeks. Mostly they occur sub-clinically, without the knowledge of the mother (by one expert source, 52% of all women who conceive experience early miscarriage…)             

RT@bioZhena: RT@BabyMed: Can #pregnancy result from sex on period? Yes, if it’s a very short cycle (due to a very short follicular phase) – which is unlikely – as the pre #ovulation phase is rarely that short. Since teenage cycles tend to be irregular and often short, this is of particular interest to sexually-active teens.  You must MONITOR your cycles if you don’t want any such surprise

RT@bioZhena: RT@BabyMed: Can #pregnancy result from sex on period? See here how unlikely it appears http://to.ly/1k9L . Unlikely, if the shortest follicular phase is 6 days. Menstrual bleeding would have to be as close to ovulation as 4 days, to make the answer unequivocally positive; that would mean cycle length of 18 days (or 16 to 20 days). Very rapid dominant follicle maturation. Until this (shortest follicular phase question) is investigated with our Ovulona monitor of Folliculogenesis In Vivo™ [FIV™], there is probably little data to invoke. I would be interested in any evidence.

Further peri-vernal equinox tweets on #conceiving, kairos time and #fertility, achieving #pregnancy, caution about in vitro & appearances

March 20, 2010

And NFP users still know that fertility awareness

is for birth control, too

As previously noted, language aware readers and subject matter aficionados know that the “peri” in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology …” nor, for that matter, to “any lovely, graceful person” such as you are.

You already know that “peri” is a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek [http://dictionary.reference.com/browse/peri]. Just like here, whereby we take notice of the Spring Equinox – when the Sun rises exactly in the east, travels through the sky for exactly 12 hours and sets exactly in the west – this year on March 20 “, today.

And, “anyone standing on the equator at noon will not cast a shadow” [http://www.wilsonsalmanac.com/book/mar20.html]. Lovely thought [entertained in snowbound Colorado Rockies]! Then another idea, not necessarily lovely – but a key concept: The dictionary does not tell that this is one of the instances of “kairos time” of the Earth! For the meaning of “kairos time” you can check out an earlier post here, https://biozhena.wordpress.com/2007/12/28/birthday-and-how-it-relates-to-the-biozhena-enterprise-%E2%80%93-eukairosic%E2%84%A2-diagnostic-tools

Spring Equinox

Spring Equinox (aka rovnodennost)

But now for some more of the tweets (again a little edited, since here we do not have the 140 character limit. And still – in the usual manner – with clickable links to further information, including more tweets of all sorts via the #hash tags).

Do you chart your #fertility cycles? If so, would you like to include our FIV cyclic profile http://to.ly/VCF in your charts? Do let me know if interested #pregnancy #birth 7:24 PM Mar 16th

If you have not yet explored bioZhena’s Weblog http://to.ly/vUz do visit http://to.ly/1kXE Variability of menstrual cycles and ovulation timing. Read on kairos time. 8:05 PM Mar 16th

A collage that depicts our message. After disappointments, once you determine your exact “kairos time” in the cycle you want to conceive in, you’ll get the #pregnancy you wish for http://tweetphoto.com/14671191 8:38 PM Mar 16th

Collage of 3 pics with 15-WordlegreetingsfrombioZhenasf-3.jpg

Collage of 3 pics with 15-WordlegreetingsfrombioZhenasf-3.jpg

Mistiming intercourse is the chief cause of apparent #infertility http://to.ly/1ppi . With a certain Fertility Monitor, they claim that 50% of users got #pregnant in the 1st cycle, and 92% in the 3rd. 196 women provided this statistic, out of 276 women asked. “The issue of early intervention with [clinical] tests and medications were highlighted, resulting in escalating costs and strain on the couple.”  2:02 AM Mar 17th

RT@bioZhena Compare the cost of the certain Fertility Monitor, which – unlike ours – requires monthly reagent sticks, from ~$250 (1cycle) to some $550 (10 cycles). Compare that to the average cost of ART medical treatment, which they report was $6,637 for the surveyed women, with a median medical evaluation cost $1,075 per cycle 2:06 AM Mar 17th

Kirchner Modern Bohemia

... with a median medical evaluation cost $1,075 per cycle ...

Numerous papers http://to.ly/1pq1 show improved #pregnancy rates and effective #birth control with #fertility monitors. That is with focus on determining the #fertile window 2:20 AM Mar 17th

Statisticians reported on day-specific probabilities of #pregnancy with data from 2 studies that used what they called (correctly) Imperfect Measures of ovulation http://to.ly/1pqh They did not ask: Perfect Measure of ovulation soon? 2:34 AM Mar 17th

*Perfect Measure*of ovulation resides in deterministic versus statistical approach.  *Imperfect* (fuzzy) replaced by accurate #fertility determination that indicates the first fertile day and the last fertile day, day 1, day 2, day 3, boom, boom, boom 2:49 AM Mar 17th

Fertile window of opportunity to conceive

Fertile window as determined by the Ovulona, and how it compares with the BBT

You should understand: No in vitro diagnostics (out of body), no circulating hormones like LH and/or estrogen can ever make a RELIABLE #fertility monitoring method because fertility is the result of a complex integration or interplay of numerous neuroendocrinological signals. This or that hormone in a body fluid does not do that. (It’s merely one of many input signals. In case of the BBT, more like an output.)

Similar caution applies to NFP observations of #fertility signs. Mucus is a measure of estrogen. It does NOT show the boundaries of the #fertile window, it only indicates ovulation is likely, but not when, and not really if

Your #cervix receives #fertility signals from the active ovary and from your brain. But understand that the cervix appearance and feel only indicates approaching #ovulation, not ovulation as such

The appearance of the cervix, like (the appearance of) ovarian ultrasound will indicate that ovulation was yesterday. Or, more accurately put, ultrasound indicates that the follicle collapsed and PERHAPS (80% probability) released the egg

Monitoring your #fertility signs is better than nothing BUT if it’s not helping you to get #pregnant, it will #stress you out and make things worse

Until you use a definitive deterministic tool, “better than nothing” is arguable if you take it from the statisticians that having intercourse about every day for 20 days is 60% likely to result in conception

Of course, you would still have ~40% probability of not achieving #pregnancy so what is new. That is the meaning of #subfertility. Need a solid tool that determines the 3-day fertile window, boom, boom, boom (but stress may prolong this – in a detectable manner).

Our deterministic tool avoids statistics and probabilities, and detects ovulation after anticipating it from what the cervix is saying electronically now, in this cycle. Most of the time not fertile, and then for a few precious days, #fertile

Songs of Innocence and of Experience

Songs of Innocence and of Experience

To sum up: Appearances are no real measures, they are only approximate.  Approximate is not good enough for #fertility status – to get #pregnant or, especially, to avoid getting pregnant. And, especially, if you want to try for a desired baby gender.

***

FOR MORE ABOUT ALL THIS GO TO THE 2012 ARTICLE https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/ = The fallacy of ovulation calculators, calendars and circulating-hormone detectors. Don’t let them lead you by the nose with likely this and probable that! You need to know for sure.

Peri-vernal equinox tweets on #conceiving, #fertility status, achieving #pregnancy in the era of #infertility – “a modern epidemic”

March 20, 2010

NFP aficionados know that fertility awareness is for birth control, too

And language aficionados will know that the peri in the title does not refer to any “one of a large group of beautiful, fairylike beings of Persian mythology, represented as descended from fallen angels and excluded from paradise until their penance is accomplished.” Nor, for that matter, to “any lovely, graceful person.”

Peri or Paeri of Persian folklore and mythology

Peri or Paeri of Persian folklore and mythology

Peri is a prefix meaning “about” or “around” and “near”, appearing in loanwords from Greek [http://dictionary.reference.com/browse/peri]. Just like here, whereby we invoke the Spring Equinox – when the Sun rises exactly in the east, travels through the sky for exactly 12 hours and sets exactly in the west – this year on March 20. “And anyone standing on the equator at noon will not cast a shadow” [http://www.wilsonsalmanac.com/book/mar20.html]. Lovely!

So then, now for the tweets (a little edited, since here we do not have the 140 character limit, and – in the usual manner – with clickable links to further information, including the #hash tags).

1)         2009 sales of #fertility LH kits at $272M outpaced #pregnancy tests http://to.ly/1p8Q Not exactly surprising since ~30% of US women do not get #pregnant in 6 or 12 months 12:04 PM Mar 16th

2)         #Infertility is “a modern epidemic”. In 17 studies, 56% of the relevant sub-population (range 42–76%) in developed countries sought medical help http://to.ly/1pdo but less than 1/2 of them received care 2:30 PM Mar 16th

3)         Unintended pregnancies = “global epidemic”. US family planning is “uniquely deficient” (50%) http://to.ly/1pcB Cause: high contraceptive failure rates 2:34 PM Mar 16th

4)         Leading causes of unintended pregnancy are closely related to #contraceptive failure. Failure rates: 31% the Pill, 18% condoms, 5% 3-month injectable #birth control 2:43 PM Mar 16th

5)      Medscape OBGYN: #fertility awareness can be highly satisfactory #birth control & #family planning method http://to.ly/1peK http://to.ly/1peM 3:14 PM Mar 16th

6)      RT @bioZhena #fertility awareness [FA] is a great #birth control & #family planning method especially for women 30+ years of age, and those who are able to practice FA without a teacher 3:23 PM Mar 16th

7)      Statisticians: Best frequency of sex for unfocused conception attempts is every 2 or 3 days http://bit.ly/d9tCfm to avoid exhaustion. Else, everyday 5:32 PM Mar 16th

8)      RT@bioZhena But even sex every day for 20 days from day 6 to day 25 only computes as 69% probability of conception. So what else is new in the world of sub- #fertility, wanting #pregnancy but being put into the sub- #fertile category 5:34 PM Mar 16th

9)      Trying to get #pregnant without knowing when-to frequently does not work for a long time. Yet, often all that’s needed is knowing your actual fertile window in the present cycle http://to.ly/VCF 7:18 PM Mar 16th

10)  For #fertilityawareness, NFP for #pregnancy and/or #birthcontrol, we have the tool for you http://to.ly/VCF — or, rather, will have, once funded. Comments? 7:19 PM Mar 16th

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.

About the Added Bonus of Folliculogenesis Monitoring – Automatic Pregnancy Detection

January 10, 2010

.

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

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

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

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

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

Immediate detection

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

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

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

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

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

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

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

Commenting on the Ovulona advantage

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

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

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

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

Conceptus signature - small

Conceptus signature – small

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

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

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

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

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

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

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

How it works

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

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

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

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

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

Seriousness of the EPL problem

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

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

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

Further References:

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

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

Excerpted:

Early pregnancy loss is unfortunately the most common complication of human gestation, occurring in at least 75% of all women trying to conceive. Most of these losses are unrecognized and occur before or with the next expected menses. Of those that are recognized, 15-20% are spontaneous abortions (SABs) or ectopic pregnancies diagnosed after the pregnancy is clinically recognized.

The incidence of spontaneous miscarriage is10-15%, whereas the rate of recurrent miscarriage is 3-5%.

Approximately 5% of couples trying to conceive have 2 consecutive miscarriages, and approximately 1% of couples have 3 or more consecutive losses. Early pregnancy loss is defined as the termination of pregnancy before 20 weeks’ gestation or with a fetal weight of

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

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

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

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

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

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

What Women Know, And What They Want To Know About Their Fertility Status

October 10, 2009

There: What Women Know

Despite the many BBT charting apps and some BBT monitors, and despite the urine analyzing (or the saliva testing) products on the market, here is a fundamental fact:

There is no device in the marketplace today that would tell you, in plain English, “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy.  And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. There is no device out there that would detect (not just guess at) ovulation, which will enable you to try to conceive a girl, if that is what you wish for.

There is no such device on the market that would subsequently confirm the pregnancy within a day or two – when, after ovulation on fertile day 3, you or rather your Ovulona device for you – will no longer register the usual follicular waves. Your Ovulona device will interpret that as pregnancy detected, because that is how the biology works.

There is no device out there that would identify the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial. The commercially available fertility monitors cannot detect either delayed ovulation (which happens due to stress) or when ovulation does not occur at all. Because they do not detect ovulation, they just guess at it.

Because the currently marketed fertility monitors (ovulation predictors) cannot detect ovulation, they merely assume its occurrence due to the particular hormonal marker-predictor of their choice (usually LH, in some cases estrogen, in one case both). But no single hormone, even if it were detected with the accuracy of laboratory methods, determines the fertile window. It’s much more involved than that.

For more on this, go to The post on The Fallacy of Ovulation Calculators, Calendars and Circulating Hormone Detectors at   https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/

Here: What Women Want To Know

Only scarcity of funds keeps us from marketing a device doing all those things not available today.

Our personal self-diagnostic device, the Ovulona™, will tell the woman user in plain English (or any other language) whether today is one of the three days when she can become pregnant.

https://biozhena.files.wordpress.com/2015/09/ovulona-single-slide-3-day-fertile-window.jpg

Ovulona - single slide 3-day fertile window

How? We’ll have the woman monitor at home the process that causes menstrual cycles and is fundamental to women’s health (folliculogenesis). The use of the Ovulona device is very simple, just like a tampon, except that it is inserted for only a few seconds (about 20) to obtain the result, with an instant display of the result.

The Smart Ovulona will display the results electronically interpreted, presented in plain language such as FERTILE DAY 1 while the raw data is stored within the device for optional use by healthcare professionals.

Primary use is for personal reproductive management – that is aiding the achievement of pregnancy, and also aiding fertility-awareness based non-invasive birth control.

But there is much more, including an automatic screening for cervical cancer, management of PMS/PMDD and management of hormone therapy, to name just a few of the applications that will come with the core technology.

We show below the working of the prototyped product using the graphs of the measurement results plotted against the days of the menstrual cycle – and compared with the woman’s basal body temperature for reference. The graphs of the measurement data produce cyclic profiles descriptive of the nuances of the monitored menstrual cycles. None of the old techniques can do that.

These cyclic profiles have important characteristics:

1. The menstrual cyclic profile has numerous repeatable features. It is an electronic signature of the menstrual cycle, which is the female 5th vital sign.

2. The range of measurement values is the same in different cycles and, importantly, also in different women.

3. The profile features are interpretable, and are due to the biological process that causes the menstrual cycle phenomena (folliculogenesis).

The significance of these menstrual cycle profiles goes beyond reproductive management.

To wit: Ours is a unique and disruptive technology.

https://biozhena.files.wordpress.com/2018/05/biozhena-corp-single-slide-3-day-window.pps Click the link or the image for a better view – an animated slide.

Fertile window for birth control

Fertile window for birth control

For a better insight, visit the other posts on this blog [https://biozhena.wordpress.com/ ], and check out http://www.linkedin.com/in/vaclavkirsner.

Before you go, see this, to get some sense of what is going on here:  https://biozhena.files.wordpress.com/2018/05/wealth-of-information-in-menstrual-profile-signature.jpg The link opens a larger version of the slide snapshot image.

Better still, click the next link for the animated and narrated slide:  https://biozhena.files.wordpress.com/2016/11/single-slide-narrated-best-wealth-of-info-in-menstrual-cycle-profile-signature.pps

wealth-of-information-in-menstrual-profile-signature

Note the planned use of the follicular waves for early pregnancy detection (the waves disappear; the right term for this is “instant pregnancy detection”), and monitoring for early pregnancy loss (in that unfortunate eventuality, the waves come back; it is advisable – by certain recent medical findings – that the couple should not delay trying to conceive again).

Refer to the following for more about said recent findings: original medical publication in BMJ http://to.ly/9WtG; BMJ editorial comment http://to.ly/9WtI; CNN.com article “Miscarriage? Try again ASAP, study suggests” http://ht.ly/2mlwb; bioZhena’s post http://to.ly/802p “Instant detection of pregnancy and of Early Pregnancy Loss, EPL – the adversary of Trying To Conceive, TTC – especially after age 25”.

———————————————————————————————————-

A party with an interest relevant to bioZhena Corporation can be provided with more confidential information upon request (email: vaclav@biozhena.com).

Visit https://www.linkedin.com/in/vaclavkirsner/ .

The Ovulona is not another ovulation kit, my dear

October 6, 2008

@bioZhena‘s reply to Jennifer K. who wrote: How is this different from the other ovulation kits on the market today? It seems very similar to products I have seen before. QUOTE UNQUOTE

Actually, Jennifer, you are mistaken. There is no such thing available to you in the marketplace today.

This blockquote is added in April 2017

Ovulona - single slide 3-day fertile window

ovulona-single-slide-3-day-fertile-window-forexs.pps

None of the ovulation kits – which the Ovulona™ is not – or any other fertility-status monitors on the market today have the required ability to determine fertile day 1, fertile day 2, and fertile day 3 (= ovulation, the last day of the fertile window).

All the existing techniques merely guesstimate the approach of ovulation, and none of them can detect ovulation separately from predicting it. They detect neither the first day nor the last day of your brief fertile window – so, they declare the fertile window to be wider than it actually is.

Let’s try to illustrate this with the following graphical comparison of the Ovulona 3-day fertile window versus the fuzzy and much wider, uncertain window indicated by one of the old techniques. (In this case depicted here it was the so-called Peak mucus method but LH kit and BBT yielded similarly wide and fuzzy fertile periods, that is the days on which intercourse resulted in pregnancy.)

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

Ovulona 3-day fertile window versus one of the old methods

Because in the Old Method ovulation was only guessed at, a fuzzy fertile period obtained.

Fuzzy and long. Wrong.

There is no device in the marketplace that would tell you, in plain English (or in Spanish, Chinese or maybe even in Czech!), “today is your fertile day 1” – meaning that sex today is likely to lead to pregnancy. And from our clinical trial results you will know that the pregnancy conceived on this first of the fertile days is likely to be a male fetus, a boy. We base this expectation on the results of other people’s studies, referenced below.

The rationale, briefly, is this: 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. With the Ovulona, the rationale will have a chance to be tested and/or utilized in real life…

No such powerful tool out there

There is no device that would – subsequent to determining the days of the fertile window – confirm the pregnancy within a day or two. When, after ovulation on fertile day 3 (indicated in the graph here as day 0), your Ovulona would no longer register the usual follicular waves – and the device would interpret that as pregnancy detected, because that is how it works.

In gynecological convention, days of the menstrual cycle are counted from the first day of menstrual bleeding, but the researchers involved in studying the prediction of ovulation use also another counting system. In that counting system, the day of ovulation is day 0 (zero). This is to allow for comparisons of different cycles, because cycle lengths as well as the phases of the menstrual cycle vary from month to month and also, of course, from woman to woman.

Because the sperm can remain viable for several days but the egg can be fertilized only for several hours after ovulation, there are several fertile days before ovulation. Should the egg remain viable for fertilization longer than the believed 12 to 24 hours, there would be also one fertile day after the day of ovulation. Delayed ovulation will have this effect and this is discussed below. Only our menstrual cycle tracking technology can detect delayed ovulation, a very important attribute.

We believe that published evidence from clinical studies of this problem leads to the conclusion that there are only 3 days of high probability of getting pregnant, and that the ovulation day is the last day of this narrow fertile window.

3-day fertile window vs. old method e2

For more on the foundation of this hypothesis (i.e. for the working hypothesis of the 3-day fertile window), see https://biozhena.wordpress.com/2007/12/03/fetal-sex-preselection-%E2%80%93-illustrated/ where we show the outcome of the France et al. study of fetal gender pre-selection superimposed on the menstrual cyclic profile generated by our device in a small clinical trial. This indicates how baby gender pre-selection works or rather how it will work when the Ovulona™ is launched in the marketplace.

This is how come that, in the illustrations above including this one, the days of the fertile window are counted back from ovulation, and hence their negative signs in the graph. Day -2 on this time scale is the first day of the fertile window. It is clearly discerned in our menstrual cyclic profile signature, as shown in the first illustration of this post.

How prior art products and methods fail

If you only detect the ovulation day with your LH kit, it is too late for the previous 2 fertile days. Similarly, if you detect an elevated BBT temperature, which rises and remains elevated after ovulation, it is also too late. The timely determination of the pre-ovulation fertile days has always been THE key problem for NFP [Natural Family Planning] and generally for the Fertility Awareness Based Methods of reproductive management.

There is no device out there that would determine the only 3 days in each menstrual cycle during which – and only during which – pregnancy can result from insemination, whether natural or artificial.

The other fertility monitors – including the more recent smart phone apps – cannot detect delayed ovulation (which happens due to stress) despite the LH hormone signaling that ovulation should go ahead. Neither can the various other monitors warn you when ovulation cannot occur because of the failure of dominant follicle maturation in the present menstrual cycle.

There is no other device that would enable you to avoid the expense and hassle of trying to become pregnant with the help of the costly Artificial Reproductive Technologies when your dominant follicle maturation is not happening – which is only detectable with our folliculogenesis-tracking little device for home use.

Your gynecologist, your family doctor – or your psychiatrist if you suffer badly with PMS (diagnosed as PMDD) – does not have the benefit of the folliculogenesis cyclic profiles stored in the Ovulona memory for better diagnosis and better treatment than you can get today. They do not as yet have the benefit of systematic longitudinal recording of your menstrual cycle vital sign signatures, to facilitate better diagnosis of a health problem such as you may have.

There is no other technology that would – automatically and without bothering you at all – keep track of whether your cervical tissues are healthy, and would issue a warning only when detecting tissue aberration several months in a row – to spare you the anxieties and expenses associated with the Pap smear cervical cancer tests’ frequent false positives. Yes, this too is a functionality planned for the Ovulona in the future.

There is no technology as yet available to all women worldwide with these empowering features at a perfectly affordable cost.

oh yeah

oh yeah

Read also the 2012 article https://biozhena.wordpress.com/2012/02/13/the-fallacy-of-ovulation-calculators-calendars-and-circulating-hormone-detectors/The fallacy of ovulation calculators, calendars and circulating-hormone detectors.  Don’t let them lead you by the nose with likely this and probable that! You need to know for sure. Day 1, day 2, day 3. Simple.

Should you want to look deeper into this, do check out the  Home Page of bioZhena’s Weblog

Contact me via email at vaclav@biozhena.com


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