July - August 2010

Summer is usually not a very news-intense period. We, therefore, historically take CHR Update into hiatus during July and August. But when something newsworthy comes up, we do not hesitate to go back on-line. CHR is fully staffed all summer, and we actually during the hot summer months usually work overtime.

The ESHRE Meeting

CHR's Medical Director, Norbert Gleicher, MD, and visiting CHR staff member, Dozent Andrea Weghofer, MD, from Vienna University in Austria, represented CHR at this year's annual meeting of the European Society of Human Reproduction & Embryology (ESHRE). Taking place in beautiful Rome, Italy, it met, and in selected aspects, exceeded expectations, both in the positive and the negative.

Rome is, of course, almost unbeatable in beauty. No matter how many times one has seen St. Peters Basilica, the Vatican Museum, the Roman Forum, Colosseum or even the Great Synagogue of Rome in the ancient Jewish Ghetto (now prime real estate) before, one is always smitten by the uniqueness of the innumerable landmarks of this very special city.

Unfortunately, the days of the congress were almost unbearably hot and, coming from the U.S., good air conditioning in the "old world" seemed sparse, and not infrequently completely absent.

Most surprising was the chosen venue for the congress. Located at Fiera Roma, Rome's new exhibition center, the congress really did not take place within Rome's city limits. Indeed, Fiera Roma is practically as far removed from the city as its airport, and Rome's airport is not amongst the closest to the city in Europe. While shuttle busses were announced, they were so infrequent that, for all practical purposes, one had only two choices: either take the train (imagine taking the train to your lecture!) or taking a taxi at a cost of ca. €45.00 (almost $60.00) in one direction.

This is, however, not where the story ends: After reaching the entrance to the grounds of the exhibition center (an accumulation of 14 huge exhibition halls, lined up in two rows) by taxi, local rules did not permit cabs to enter the convention center grounds with passengers. Passengers had to be offloaded at the entrance, from where (in, likely, at least a half-mile walk) everybody had to find his/her way on foot (in 90-100 degrees) to halls 5-10, where the various activities were spread out.

No wonder then that, announced as the meeting with the largest attendance ever, participation in lectures dwindled very rapidly. By the third day attendance in these huge lecture halls appeared almost comical.

This very apparent break down in organization is regrettable because, as noted by Focus in Reproduction, ESHRE's official organ, an unprecedented increase in abstract submissions had taken place this year (33% increase from 1154 in 2009 to 1539 in 2010). An interesting side statistic was that the USA, with 86 submissions (18 accepted for oral and 44 for poster presentations, 62 combined), was outsubmitted by Spain (157), Italy (128), and the UK (114) but not outaccepted for presentation. With 72.1% of all U.S. submissions accepted for either oral or poster presentation, only The Netherlands came close (81/23/35, 71.2%). Bigger submitters, quite obviously, went for quantity over quality (Spain's acceptance rate 53.5%; Italy's 45.3% and the UK's 59.7%, respectively).

Maybe most interestingly, CHR presented two out of only 18 oral U.S. papers – not bad for one small U.S. -based infertility center!

And how was ESHRE in regards to the presented science? The truth is that this is a difficult question to answer because large meetings, like ESHREare difficult to assess. Were there any groundbreaking news? The answer is NO! This is best demonstrated by which paper got the most media attention. Interestingly, this was probably a paper from an Iranian group, presented in the same first session on "ovarian reserve" of the congress (when the public still was quite large) as one of our center's papers, presented by Dr. Weghofer. Two slots ahead of our paper, these investigators suggested that age at menopause may be predictable based on anti-Müllerian hormone (AMH) levels [Ramezani Tehrani et al., Hum Reprod 2010;25(Suppl 1):i2].

Readers of CHR Updates, of course, know for quite some time about the predictive abilities of AMH levels. The special recognition this paper received from the media, therefore, is reflective of the paucity of really groundbreaking work at this congress. One also cannot help but wonder how much political correctness played a role in giving special attention to a paper from Iran.

Some of the more interesting studies presented were actually amongst poster presentations. This is somewhat unusual, though not uncommon, since the most interesting papers are supposed to be selected for oral presentations. Which papers are chosen for oral and/or poster presentations is usually determined by committee and, while probably the best possible method, it is anything but perfect.

So, in summary, it was great being in Rome. Only too bad that attending the congress required that we spent most of the time in ugly concrete shells somewhere in the country, far removed from Rome's beauty and such places as Piazza di Spagna, Piazza Navona and Piazza del Popolo. Fortunately, however, evenings were free and, if one knows where to have dinner in the city, it could more than make up for all the "suffering" during hot days in the country.

Is infertility a disease?

Two infertile Austrian couples won a decision in their favor in front of the European Court of Human Rights, which ruled that the country's ban on sperm and egg donation violated the right to respect family life, and that not allowing them the use of donor gametes (when others could use their own) was discriminatory.

As quoted in Focus on Reproduction (May 2010), Luca Gianaroli, MD, current ESHRE Chairman, feels it is too early to determine what this decision means for other European countries but believes that the ruling sets a precedent that restrictions on gamete donations are in violation of the European Convention on Human Rights.

This argument is similar to that of the Human Rights Commission in the State of Illinois, which, quite a number of years ago, based on a challenge by a CHR (Illinois) patient, ruled that withholding infertility care, in contrast to other medical services (which are offered), is discriminatory under the Americans With Disability Act. Under that ruling, Illinois State was practically mandated to provide comprehensive infertility services to all of its employees.

Infertility is increasingly defined as a "disease." At a presentation in Rome, ESHRE for the first time presented a number of new definitions, which included infertility as a "disease," rather than "diagnosis" or "condition." The reason is clear: diseases fall under coverage by medical insurance; diagnoses and conditions may not!

The ESHRE representative, summarizing these new definitions, also noted that Europe does not have a legal framework like the Americans With Disability Act, which prohibits discrimination against basic life activities (including reproduction) and, therefore, had to resolve to define infertility as a disease.

Such a definition, however, of course raises quite a number of potential issues: Is infertility one disease or a compendium of many diseases? How can one consider male infertility within the same framework as, for example, tubal disease?

The biggest issue may, however, lie with the fact that diseases usually require treatments (unless, of course, known to be self-limited). In association with infertility (undoubtedly not a self-limited condition), presence of the "disease" does not necessarily indicate intent to conceive. Indeed, it is well known that a large percentage of infertile couples (for whatever reasons) choose not to even pursue diagnosis. Amongst those that reach confirmatory diagnosis, many choose not to pursue treatments and amongst those who do, many voluntarily drop out of treatment.

Which percentage of truly infertile couples end up receiving fertility treatment is, therefore, rather poorly defined. Definition of infertility treatment needs is further complicated by the fact that, increasingly, single and gay women also seek out fertility treatments while widely recognized definitions of infertility require "regular exposure to semen" over a defined time period.

Words and their definitions are of great importance! Whether infertility is a disease is, for example, of great importance when it comes to designating pharmaceutical agents as so-called "orphan drugs." The Food and Drug Administration (FDA) has the power of such designation when the number of potential individuals affected by any given disease is below a certain cut off. The idea is that large pharma companies are not interested in developing drugs for small markets. Such "orphan drugs," therefore, deserve the FDA's help.

Probably no area in medicine would need such help as much as infertility. Yet, because infertility is seen by the FDA as a "disease," and since approximately 7.4% of married couples are believed to be "infertile," the FDA recently rejected an orphan drug application, which attempted to develop an innovative approach towards treatment of diminished ovarian reserve. The argument was that the infertility market was too large for an "orphan drug" designation, completely ignoring the fact that, in contrast to practically all serious diseases, only a small fraction of infertile patients ever seek out treatment.

Defining infertility as a "disease" is, therefore, not always beneficial!

- The CHR

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