Why “The Wyden Bill” Does Not Support Infertility Patients

David Kreiner, MD Regulation of IVF 0 Comments

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Patients often seek my help, desperate to try In-Vitro Fertilization (IVF) after having a previous cycle cancelled at an outside clinic. These patients stimulated with fewer follicles and therefore due to their lower pregnancy expectations were not allowed to proceed. We presented our data on IVF performed on patients with 3 or fewer follicles at the American Society for Reproductive Medicine (ASRM) (insert hyperlink to www.asrm.org) in 2008. Our pregnancy rate was 15% for this group. Though this is admittedly low, for those who were successful in having a baby using their own eggs it was felt by them to be miraculous because they were either not allowed to cycle at other centers or had their cycles cancelled.

We counseled them regarding their lower odds for success but some elected to give it a try. Previously, most of these patients were offered Intra-Uterine Insemination (IUI), a much less successful option that does not affect the programs reportable pregnancy rates.

Unlike most other fields in medicine, IVF results are subject to public reporting since the passage of the Wyden Bill in 1992. The intent of the CDC (Center for Disease Control) report and SART (Society of Reproductive Technology) report was to help infertility patients by informing them of the relative success of different IVF programs. Unfortunately, what sometimes creates the best IVF statistical outcomes in pregnancy rates is not always what is in the best interest of the mother, child, family and society. Now that prospective patients are comparing pregnancy rates between programs there is a competitive pressure on these programs to produce the best reportable rates. This means that patients with lower odds of success are less likely to be offered IVF retrievals and are diverted to IUIs or donor egg cycles.

The high order multiple birth rate was also fueled by competition in the field to have the highest success rates. The Wyden Bill results in competitive pressure to transfer more embryos to increase pregnancy rate as reported. Despite the fact that there is evidence that a program can achieve similar live birth rates by transferring a single embryo each time, the Wyden Bill creates a disincentive to do so. It is no surprise that the clinics with the highest success rates have also had the highest triplet rates. Live birth rates are reported per fresh cycle and those from subsequent frozen embryo transfers are not included. It is true that live birth rates are reported for frozen embryo transfers separately but again it is per transfer motivating programs to transfer multiple embryos to enhance their success rates. If live birth rates were reported per fresh IVF stimulation and retrieval (that part of IVF with risk) including those conceived from subsequent frozen embryo transfers then programs would be likely to provide the less risky option of single embryo transfer to patients.

William Petok, Ph.D the Chair of The American Fertility Association’s Education Committee reported on Single Embryo Transfer (SET) “Single Embryo Transfer: Why Not Put All of Your Eggs in One Basket?” He stated that “at the ASRM meeting in November of 2008 … data was reported that looks favorably at SET. A Center for Disease Control researcher said that although multiple rather than single embryo transfer for in-vitro fertilization is less expensive in the short run, the risk of costly complications is much greater. Universal adoption of single embryo transfer would cost patients an extra $100 million to achieve the same pregnancy rates as multiple embryo transfer, but this approach would save a total of $1 billion in healthcare costs.

The risks of prematurity and pregnancy complications are far higher in multiple pregnancies than in singleton pregnancies. The financial and emotional costs to families and society are enormous. These multiple pregnancies result in much longer hospitalizations, NICU admissions, complications resulting in handicapped children and occasionally death. They often do not have a happy end including increasing the incidence of divorce. So does it not behoove insurance companies to make IVF available in such a way that encourages SET? Should not the government enforce the recommendations of SART regarding the number of embryos to transfer?

At ECF, we have, since 2006 offered our Single Embryo Transfer program to cover the financial cost for transferring one embryo at a time. For the fee of one IVF cycle, we offer free cryopreservation, embryo storage and unlimited frozen embryo transfers until a patient achieves a live birth.

We offer MicroIVF, minimal stimulation IVF, for $3900, less than the cost of 2 IUIs with three times the success rate and ¼ the risk of hyper stimulation syndrome. Since minimal stimulation does not result in as many eggs, many programs are uncomfortable offering it and therefore lowering their reported pregnancy rates.

If we are going to report pregnancy rates with IVF as is required by the Wyden Bill, let us put all programs on the same playing field by enforcing the number of embryos to be transferred and promoting minimal stimulation IVF as a safer and more efficient treatment than IUI.

The Wyden Bill without the teeth to regulate such things as the number of embryos transferred and reporting success per stimulation and retrieval and not by isolated embryo transfer does more harm than good. Let us support efforts to reduce the number of embryos transferred by removing the added costs to the patient of cryo-preservation, storage and subsequent frozen embryo transfers and by absorbing them ourselves as a profession. This will go a long way in eliminating multiple birth pregnancies, and will do the right thing for the patients, their families and for society. It’s time for us doctors to “Man Up”.

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