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So far, 2009 seems to be the year of controversies in the field of Assisted Reproductive Technologies (ART). To start, there were the octupulets born through IVF in California. Then, an IVF clinic claimed that they are capable of creating embryos with physical traits of parents’ choice, reigniting the old fear of “designer babies” from the early days of IVF. As if that wasn’t enough, a group of researchers then came out with a paper suggesting that the rate of birth defects increases after IVF. For each of these developments, CHR’s Medical Director, Norbert Gleicher, MD, made CHR’s position clear, in his effort to fight misconceptions created by the irresponsible minority in the specialty.
Implications of the Octupulet Case
As we don’t wish to add too much to the farce surrounding the Californian octupulets, we will limit our commentary here to the legal implications of the case. The case sparked calls for more regulatory intervention from a wide range of commentators, including the otherwise conservative Bill O’Reilly. The media, however, failed to note that probably no medical field was as strongly ‘regulated’ by state and federal rules as IVF. They also failed to note how rare such obvious transgressions of voluntary guidelines were.
Some media organizations, therefore, only too willingly jumped on a recent announcement by the CDC, which claimed that a large majority of IVF programs transferred more embryos than recommended by the ASRM/SART guidelines. What CDC (and the media) did not note in their announcement is that ASRM/SART guidelines, correctly in our opinion, allow for some flexibility in the number of embryos transferred. While basic numbers of recommended transferred embryos are determined by age of the woman, guidelines allow at every age for a small range, based on secondary factors, such as ovarian functional reserve (i.e. number of eggs retrieved), embryo quantity and quality, and prior IVF cycle experiences. As meant by the guidelines, those secondary factors will always result in upward adjustments in suggested embryo numbers, to compensate for unfavorable factors, but will be invisible to CDC statisticians.
When asked, on a MSNBC News program, about potential legislative control over the number of embryos to be transferred, Dr. Gleicher, rather categorically opposed more stringent regulation of the number of embryos transferred. He equated such an approach to recommending that “legislative control over newspapers be mandated after one journalist is caught making up fictitious stories.” He then in the same program picked up on a suggestion made by CHR’s business manager Jolanta Tapper (always the business person) during in-house discussions about the octuplets, when she, half serious and half joking, suggested that, “maybe, the physician in this case is best held responsible for the octuplets’ education costs.”
Designer Babies?
After the news cycle about the California Octuplets finally appeared to have run out of steam, there came yet another California-based colleague of ours, who found it necessary to stir up the public with the announcement that, starting in 2010, his clinic will offer patients the ability to select embryos for cosmetic traits, such as eye color, hair color and even skin tone.
The media, of course, had another field day because, primed by an obviously inappropriate medical provider in the octuplets case, here, quite apparently, was once more convincing evidence for the irresponsibility of the medical profession in the field of assisted reproduction. And who can blame the media for such conclusions?
The physician heads what on the website is called The Fertility Institutes, with one confirmed location in Encino, CA. Although his clinic offers comprehensive infertility services on its website, it is apparent that gender selection defines the identity of this clinic, which calls itself the world’s largest provider of sex selection IVF cycles, with thousands of patients having chosen the center’s services from all over the world.
Gender selection through preimplantation genetic diagnosis (PGD), first of all, necessitates an IVF cycle. Therefore, when we realize that, according to the latest CDC data, this “largest sex selection center in the world” has done only 127 cycles of fresh IVF and 38 egg donation cycles, the claim starts to fall apart. This means that, even assuming that all IVF cycles at this institute were done for the purpose of sex selection (a not very likely assumption), it is difficult to understand where the thousands of sex selection cycles were done (of course, with 100% accuracy!), claimed by its official website.
In most of its currently used clinical applications, PGD is a highly complex technical procedure, used to prevent specific genetically inherited diseases in offspring. A wider application of PGD, in an attempt to improve IVF pregnancy rates and reduce miscarriage rates, by selecting chromosomally normal embryos has, as we have extensively written about in many publications, been proven to be mostly ineffective. Indeed, in an older patient population, the additional trauma of embryo biopsy required for PGD may actually reduce IVF pregnancy rates (Gleicher et al., Fertil Steril 2008;89:780-8).
The concept that, assuming the technical ability to affect cosmetic traits reliably, masses would suddenly flock towards PGD to produce blond, blue-eyed offspring, is just as unrealistic as the other fantasy propagated by the institute’s website’s—of thousands of alleged sex selection cycles. Only few couples choose gender selection, even though it has become quite freely available in the U.S (CHR has offered the service for years). Even fewer would choose PGD for cosmetic reasons. You have to give it to the guy, however; he really pulled off a remarkable P.R. stunt!
Increased Risk of Birth Defects after IVF?
After over 3 million IVF births worldwide proved the initial concerns about “freakishly malformed babies” (Peggy Orenstein, New York Times, July 20, 2008) wrong, suddenly the specter of a higher birth defect rate following IVF, once again, became a favorite media topic in March.
It all started with one study published by investigators from the National Center on Birth Defects and Development Disabilities, Centers for Disease Control and Prevention in Atlanta (Reefhuis et al., Human Reprod 2009;360-6), in which the authors reported increased rates of septal heart defects (OR =2.1; 95% CI 1.1-4.0); cleft lip with and without associated cleft palate (OR 2.4; 95% CI 1.2-5.1); esophageal atresia (OR=4.5; 95% CI 1.9-10.5) and anorectal atresia (OR = 3.7; 95% CI 1.5-9.1). On first glance, these data appear impressively significant. Reviewed in more detail, however, significant questions arise about their scientific validity.
Among other issues, the study compared infertile women treated by IVF with women who spontaneously conceived and, therefore, quite apparently did not suffer from infertility. It has been known forever that women requiring infertility treatments give birth to children with slightly increased risks towards birth defects in comparison to spontaneously conceived offspring from fertile couples. Any study attempting to determine whether IVF/ART increases birth defects, therefore, should compare IVF cycle outcomes to outcomes of other infertility treatments. The study format chosen by Reefhuis et al cannot differentiate between effects of infertility in general and effects of IVF on risk towards congenital abnormalities.
In recent years, based on a tiny number of cases, a special group of extremely rare congenital birth defect risks (such as Beckwith-Wiedermann syndrome, Angelman syndrome and retinoblastoma) has been suggested to be directly associated with ART. Whether there even is a genuine association between ART and these disorders is still unproven and has recently been questioned by a group of investigators from the Reproductive Biology and Medicine Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, in Bethesda. Because such imprinting disorders are rare (< 1:12,000 births), the authors currently recommend against routine screening for these disorders in children conceived with ART (Manipalviratn et al., Fertil Steril 2009;91:305-15).
Unfortunately in medicine, poor data and/or incorrect interpretation of data so often lead to poor clinical decision making and, even more unfortunately, to wrong authoritative recommendations. (Readers might recall the old fear about the alleged cancer risks associated with fertility drugs.) The above cited paper of Reefhuis et al is no exception. Perhaps not surprisingly, the United Kingdom’s by now notorious Human Fertilization and Embryology Authority (HFEA) is, according to reports in British and U.S. media, updating its IVF guidance based on this single, obviously flawed, paper by Reefuis et al. It appears that HFEA is out to prove to the rest of the world how bad and illogical government interventions into daily medical practice can be!
We are convinced that, beyond extremely minor direct risks from ART along above-outlined possibilities, appropriately conducted studies will soon debunk the allegedly increased risks towards birth defects in association with IVF, just as properly controlled study years ago erased the anxiety over ovarian cancer risks associated with fertility drugs.
IVF is an extremely safe procedure. Introducing baseless fear into already stressed-out infertile patients seems not only unwarranted, but almost cruel. Infertile couples should not have to worry about speculative risks!
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- "Nancy and Gene," New South Wales, Australia