The Playing Field is Changing . . .

7 01 2014

To the Editor:

The clinical practice of assisted reproductive technology (ART) has continued to evolve rapidly. The Practice Committee of the American Society for Reproductive Medicine (ASRM) in collaboration with the Society for Assisted Reproductive Technology (SART) in October 2012 e-published a guideline indicating that the cryopreservation of oocytes should no longer be experimental (1). As a direct result, the current system of data collection for SART and the Center for Disease Control and Prevention (CDC) requires revision. Additional data collection is required to comply with the Fertility Clinic Success Rate and Certification Act (FCSRCA) of 1992 (Wyden Law).

Moreover, other trends in ART practice have been identified. The freezing of embryos following blastocyst biopsy is often necessary to allow adequate time to obtain results of genetic testing prior to embryo transfer (2). Some clinics also freeze eggs or embryos from multiple stimulations/retrievals prior to transfer as a strategy to manage low responder patients (3). Critiques of our current reporting system together with suggested changes have recently been published by SART members (4, 5). SART has been well aware of these practice trends and the inability of our current reporting system to handle them. Many in-depth discussions have occurred involving the SART Executive Council, the CDC, and various SART members. We have sought to balance the burden of additional data collection with the benefit of a more complete, accurate, and transparent report. A substantial upgrade to the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) software was needed to accommodate our goal and this has been completed. The Registry Committee has devised and recommended changes to data collection, which have been approved and will begin next year. These changes were presented at the SART business meeting at the ASRM meeting this year. The slide presentation detailing these changes is available on the SART website in the Members Only area. A webinar is being scheduled so that these changes can be reviewed. The new data collection will begin for the 2014 reporting year. The new report reflecting these changes will be published beginning in 2016 (shortly after the 2014 data collection is finalized).

In accordance with the intent of the Wyden law, data collection will include all stimulation cycles to obtain oocytes to freeze or create embryos. In addition, we will be able to link the oocytes or embryos by using the date of retrieval to any embryo(s) transferred. We feel that by connecting the two, the most accurate data will be generated, taking into account the stimulation, retrieval, transfer, and outcome. Our report will, therefore, shift to reporting the initial transfer or primary transfer following a retrieved cohort rather than a “fresh.” Occasionally, the retrieval and the transfer will not occur in the same reporting year. We have developed appropriate mechanisms to handle these situations fairly. A guidance addressing how this is to be handled will be forthcoming.

While we are excited to see progression and change in our field, we feel that a coordinated approach to data collection will allow a better and more accurate report without overburdening our member clinics. Our goal remains to provide the best information to our patients in a timely manner.

David Ball, Ph.D., Seattle Reproductive Medicine, Seattle, Washington
Charles Coddington, M.D., Mayo Clinic, Rochester, Minnesota
Kevin Doody, M.D., Center for Assisted Reproduction, Bedford, Texas
Glenn L. Schattman, M.D., Weill Medical College of Cornell University, New York, New York
James Toner, M.D., Ph.D., Atlanta Center for Reproductive Medicine, Atlanta, Georgia
Bradley J. Van Voorhis, M.D., University of Iowa Hospitals and Clinics, Iowa City, Iowa
Robert S. Williams, M.D., UF and Shands Reproductive Medicine at Spring Hill, Gainesville, Florida

References

1. ASRM. Mature oocyte cryopreservation: a guideline. Fertil Steril 2013;99:37-43.

2. Scott RT, Upham KM, Forman EJ, Zhao TZ, Treff NR. Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial. Fertil Steril 2013;100:624-30.

3. Cobo A, Garrido N, Crespo J, José R, Pellicer A. Accumulation of oocytes: a new strategy for managing low-responder patients. RBM Online 2012;24:424-32.

4. Meldrum DR. Pregnancies and deliveries per fresh cycle are no longer adequate indicators of in vitro fertilization program quality: how should registries adapt? Fertil Steril 2013;100:620-1.

5. Kushnir VA, Vidali A, Barad DH, Gleicher N. The status of public reporting of clinical outcomes in assisted reproductive technology. Fertil Steril 2013;100:736-41.

Published online in Fertility and Sterility doi:10.1016/j.fertnstert.2014.01.002

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