CHR Update

The following articles represent an update on CHR activities. If you want further information on any of these articles, please contact us. CHR is a comprehensive fertility center in New York, NY.

January 2012

Welcome to the Year 2012! We hope you had a wonderful Holiday Season and did not gain too much weight. But if you did, so did we. So, let's agree to lose it together in the New Year!

At CHR, the Holiday Season was unusually busy. The year-end is always an extremely active time at the center since many patients want to complete treatments before tax and insurance years end. The week between Christmas and New Year is, however, usually rather sedate. Not so this year! Where we usually barely see any new patients during this last week of the year, this year we had over 20 new patient bookings from all over the world.

We hope that this is reflective of an improving economy but it certainly is reflective of the considerable, indeed unprecedented, growth CHR experienced during 2011. We, therefore, significantly expanded our clinical and laboratory staffs and, as we previously noted in various issues of UPDATE, have set into motion the physical expansion of the center, with construction set to start in early 2012.

We also have started the recruitment process for a third full-time physician. CHR is, thus, moving into 2012, blazing on all cylinders, and looking forward to many important changes, hopefully all for the better!

The year 2012, therefore, promises on many different levels to become an unusually exciting year at the center. Since all new evolves from the old, allow us to present a brief potpourri of the old (2011) leading towards the new (2012).

CHR publications

No less than 14 peer-reviewed publications in highly prestigious medical journals represent CHR's 2011 publishing output. This, likely, exceeds the annual output of most major university departments. The listing below offers a glimpse of the breadth of research conducted at CHR. While a large majority of publications, of course, appeared in medical journals within the medical specialty of reproductive endocrinology and infertility, a surprising number were published in more general medical journals.

The wider a journal's coverage area, the more competitive acceptances tend to be, because of increasing competition for limited publication spaces. Noteworthy, therefore, are a first-ever publication from the center in the prestigious Journal of Clinical Endocrinology and Metabolism, the official publishing organ of the Endocrine Society, and of all endocrinology; a publication in the Journal of Autoimmunity and in Autoimmune Reviews, each, both prominent rheumatology journals; another paper in Dermatology, of course a dermatology journal; and, finally, for the second year in a row, a paper in PLoS ONE, the leading general medical online journal.

  1. Gleicher N et al. Toward a better understanding of functional ovarian reserve: AMH (AMHo) and FSH (FSHo) hormone ratios per retrieved oocyte. J Clin Endocrinol Metab 2011; In press.
  2. Gleicher N. Eliminating multiple pregnancies: an appropriate target for government intervention? Reprod Biomed Online 2011;23(4):403-6.
  3. Gleicher N et al. The role of androgens in follicle maturation and ovulation induction: friend or foe of infertility treatment? Reprod Biol Endocrinol 2011;9:116.
  4. Gleicher N et al. Low-intensity IVF: real progress? Reprod Biomed Online 2011;23(3):247-8.
  5. Weghofer A et al. Anti-Müllerian hormone levels decline under hormonal suppression: a prospective analysis in fertile women after delivery. Reprod Biol Endocrinol 2011;9:98.
  6. Gleicher N et al. Cutting edge assessment of the impact of autoimmunity on female reproductive success. J Autoimmun 2011; In press.
  7. Gleicher N, Barad DH. Dehydroepiandrosterone (DHEA) supplementation in diminished ovarian reserve (DOR). Reprod Biol Endocrinol 2011;9:67.
  8. Gleicher N, Barad DH. Gestational dermatosis shortly after implantation associated with parental class II HLA compatibility and maternal immune activation: preliminary report of a prospective case series. Dermatology 2011;222(3):206-11.
  9. Weghofer A et al. Live birth chances in women with extremely low serum anti-Müllerian hormone levels. Hum Reprod 2011;26(7):1905-9.
  10. Gleicher N et al. Association of FMR1 genotypes with in vitro fertilization (IVF) outcomes based on ethnicity/race. PLoS One 20116(4):e18781.
  11. Gleicher N et al. Successful treatment of unresponsive thin endometrium. Fertil Steril 2011;95(6):2123.
  12. Gleicher N et al. Defining ovarian reserve to better understand ovarian aging. Reprod Biol Endocrinol 2011;9:23.
  13. Barad DH et al. Utility of age-specific serum anti-Müllerian hormone concentrations. Reprod Biomed Online 2011;22(3):284-91.
  14. Gleicher N et al. Do chromosomally abnormal pregnancies really preclude autoimmune etiologies of spontaneous miscarriages? Autoimmun Rev 2011;10(6):361-3.

An additional three publications are currently in press, and have not yet appeared but are expected in early 2012. If you are interested in reading any of the here listed publications, please contact us. We gladly will e-mail, fax or mail you reprints.

CHR research

This publication list reflects CHR's current research interests. A few explanatory comments appear, however, in place. Even though these 14 publications appear to represent very different topics, they, in principle, are all interrelated in reflecting some core interests CHR researchers are pursuing. The big topic, as frequently discussed in UPDATE, is diagnosis and treatment of the aging ovary.

The most recent example is the 1st publication listed, which is a forerunner for much more to come because CHR investigators are determined to find better ways to assess ovarian reserve (OR) and, thereby, predict pregnancy chances in women with very poor ovarian reserve (i.e., "aged ovaries").

In this publication, CHR reports a brand-new tool, the so-called FSHo, which is a ratio of follicle stimulationg hormone (FSH) level per retrieved oocyte. The paper reports that FSHo, but not AMHo, is statistically predictive of IVF pregnancy chances. Indeed, FSH levels at all ages in women who do conceive remain exactly the same, suggesting that there may be a benefit from stimulating patients towards this FSHo level in maximizing IVF pregnancy chances.

CHR's interest in OR is also reflected in the 3rd publication on the list. Here CHR investigators review the newly evolving understanding of the importance of androgens (male hormones) for follicle development and ovulation induction. For the longest time, it was believed that androgens are bad for healthy growth and development of follicles. Now convincing evidence has arisen that androgens, indeed, are essential for the normal development of small follicles--the so called primary, preantral and early antral follicles.

CHR's experience with dehydroepiandrosterone (DHEA), itself a mild androgen, which is converted to the male hormone testosterone, of course, has been a forerunner of these developments. The new understanding of the importance of androgens to normal female fertility now validates CHR's DHEA work over many years (see also the 7th publication for 2011 listed).

Other publications address either accurate assessments of OR or treatment of diminished ovarian reserve (DOR): The 5th, for the first time demonstrates the unreliability of anti-Müllerian Hormone (AMH) testing in women after pregnancy. The 9th demonstrates the limitations of AMH at very low levels in predicting pregnancy success with IVF. This study, indeed, demonstrates how CHR still establishes respectable pregnancy rates in women, whom other IVF centers usually refuse to treat with use of own eggs. Publications #12 and #13 also address assessments of OR and treatment of DOR.

Another big research theme at CHR, related to OR, is familiar to readers of UPDATE: the FMR1 gene was repeatedly discussed in CHR publications during 2011. Indeed, because this gene has been established quite clearly as important in defining different ovarian aging patterns, it likely affects all female fertility-related studies. CHR, therefore, has started stratifying most studies for the ovarian FMR1 genotypes and sub-genotypes CHR investigators have reported in 2009/10.

The 10th publication specifically reports how the gene affects IVF pregnancy outcomes in different races/ethnicities, and reconfirms the first report in 2009 that the FMR1 gene also appears associated with autoimmune risk.

There is much more to come about this gene in 2012. Brace yourself for some rather remarkable observations, which link the FMR1 gene to other, non-fertility related medical risks of major significance. CHR research, indeed, suggests that the FMR1 gene, despite its name, fragile X mental retardation gene 1, appears associated with much more important physiological functions than neuro-psychiatric diseases, which have given it its name. Based on CHR's research, the gene's name may, indeed, have to be changed. Stay tuned!

CONFLICT STATEMENT: CHR, Drs. Gleicher and Barad have been awarded two U.S. patents, claiming therapeutic benefits from DHEA supplementation in women with DOR, improving pregnancy chances and diminishing embryo aneuploidy. Those patents have been licensed to a company called Fertility Nutraceuticals, LLC, which produces an over-the-counter DHEA supplement, called Fertinatal™. Dr. Gleicher is a share holder in this company. CHR, Drs. Gleicher and Barad also are co-inventors on pending patent applications regarding use of FMR1 testing in infertility.

CHR's publication list also includes a number of papers in the areas of reproductive immunology and autoimmunity, both long-standing research interests of Dr. Gleicher, CHR's Medical Director (#6; #8; #14). While the immune system is considered by many uninvolved in reproduction, he has argued for decades that the immune system plays a crucially important role in human reproduction, and especially in reproductive failures.

CHR recently published research that demonstrated associations between the FMR1 gene and autoimmunity, considerably strengthening Dr. Gleicher's long-held view.

The CHR publication that garnered most attention from colleagues in the specialty during 2011 was probably the 11th listed, describing CHR's preliminary experience in treating a small group of women with previously treatment-resistant thin endometrium with granulocyte-colony stimulating factor (G-CSF).

Though this paper was definitely not considered their most important paper of the year by the CHR team, G-CSF appears to offer a radically new treatment approach, and new hope for previously untreatable patients. CHR is in the midst of two clinical trials of G-CSF, with at least the results of one of them, hopefully, becoming available during 2012.

Finally, CHR investigators remained outspoken during 2011 where they believe the profession is moving into wrong directions: In the 2nd listed paper, Dr. Gleicher, in his function as one of the journal's editors, was asked to contribute a commentary, addressing the increasingly popular concept of single embryo transfer (sET). As many times discussed in these pages, CHR considers sET as a disservice to patients who are desirable of more than one child, and have no medical contraindication for twinning. The reasoning behind our opinion has been presented many times, and, probably never better and more succinct than in this commentary.

In another commentary (paper #4) in the same journal, CHR investigators address the folly of another fad in the specialty, the so-called mild or "mini" IVF, with many other acronyms in the literature. CHR's authors summarized the issue under the title "low- intensity IVF," taking the whole concept to task by critically analyzing a paper published by proponents of the approach.

What to expect

Best demonstrated by our staffing and facility expansion, we also expect significant expansion in CHR's research efforts during 2012. Even though it will still take months to enlarge our laboratory facilities, we already ordered a state-of-the arts PCR machine, which will, for the first time, allow us to do molecular genetics in house.

Our embryology team has been significantly enlarged, with the principal goal of establishing a laboratory-driven research effort, which can keep up with the center's highly successful clinical research.

Outside parties, who have come across CHR's FMR1 research, have expressed interest in potentially financing expansion of this research towards commercial exploration. In other words, CHR is quickly morphing from a fertility center into a much more multi-faceted single specialty institution.

But nothing, of course, is more important at CHR than patient care. By early February, we will be able to publish our 2011 IVF cycle outcomes. While we have data for only three quarters so far, we already can tell you that everybody who knows our center's patient population will be nothing but amazed!

Some comments about treatment costs at CHR

We are very convinced that, considering CHR's service levels and special expertise, our center's cost structure is not only very fair but actually extremely competitive. Considering the widespread economic difficulties over the last 3-4 years, we also greatly expanded discount fertility treatment options in efforts to help our patients as much as we could. In the process, quite a large number of new programs were added, from our discount program for U.S. soldiers on active duty, our income-associated discount program for patients without infertility insurance coverage, the multiple IVF cycle program for very low-chance patients with multiple prior IVF failures, to our most recently introduced Eco-Donor Egg Program (EcoDEP).

The larger the variety, the more difficult it is, of course, to be knowledgeable about all of the various fertility program costs. CHR's long-established policy of keeping clinical medical care and financial counseling strictly separate is, therefore, more important than ever.

We want to take the opportunity of starting a new year to reemphasize that CHR's physicians are never involved in insurance, billing and related issues, beyond writing support letters if asked by the Billing Department. Their job is to concentrate on offering the best possible clinical care, independent of cost-considerations. Indeed, they usually are unaware of insurance circumstances of patients they have sitting across from them during consultations. CHR has a well-trained front desk staff, ready to address all insurance and billing issues that may come up. We, therefore, request that all insurance and billing matters be brought up with our staff, and not with physicians.

CHR also follows a strict policy of non-discrimination. This means that all patients are offered the same financial opportunities, excluding, of course, income-based discounts. None of CHR's physicians, therefore, can or will overrule administrative decisions as to patient charges made by the staff.

You, of course, are welcome to appeal any staff decision, but that appeal has to stay within the administrative hierarchy of CHR. This means that dissatisfaction with information received from a front desk staff member can be taken to Ms. Ju Shan (Susan) Gu, the center's Billing Supervisor, and then even further to the center's manager, Ms. Jolanta Tapper-Tyszko. She, therefore, in regards to insurance and billing matters, is the center's ultimate decision maker!

Please contact us, as always, with comments or questions!

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-The CHR

Last Updated: December 23, 2011