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Incomplete and Inconsistent Reporting of Maternal and Fetal Outcomes in Infertility Treatment Trials

Dapuzzo, Lisa MD; Seitz, Faith E. BS; Dodson, William C. MD; Stetter, Christina BS; Kunselman, Allen R. MA; Legro, Richard S. MD

Obstetrical & Gynecological Survey: January 2012 - Volume 67 - Issue 1 - p 32–34
doi: 10.1097/OGX.0b013e3182439f1b
Gynecology: Infertility
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Infertile couples seeking in vitro fertilization treatment desire information from practitioners on the risk of adverse maternal and fetal outcomes. The ability of physicians to provide such risk information is limited. The lack of a current standard for reporting outcomes of infertility trials results in considerable variability in reported outcomes due to the difficulty of extracting maternal and fetal risk information from articles with incomplete data. It is hoped that the adoption of standards for reporting outcomes will improve the quality of published trials and allow physicians to provide more meaningful risk information.

This literature review investigated outcomes regularly reported in recent articles published in the top impact journals in obstetrics and gynecology with the aim of using these articles as examples for the development of standardized guidelines for reporting outcomes of infertility trials. A search of PubMed and online archives was conducted to identify all clinical trials in infertility published between 2004 and 2010.

A total of 294 articles were identified that met prespecified criteria for inclusion.

During the 6-year review period, there were large gaps and variability in the reporting of outcomes related to pregnancy and live birth, multiple pregnancy, and adverse events. Deficiencies in reporting included the following: pregnancy loss was not discussed in 35% of studies, and those mentioning it did not report when the loss occurred. Adverse events during the preconception treatment period were reported in only 43% of the articles. Moreover, serious adverse events were reported in less than 10% of the studies.

These findings indicate that incomplete reporting of pregnancy loss, adverse events, and other outcomes, limit the ability of practitioners to counsel patients on the risks and benefits of infertility treatment.

Department of Obstetrics and Gynecology, Lehigh Valley Hospital, Allentown, Pennsylvania; Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, Pennsylvania; Department of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania

Fertil Steril 2011;95:2527–2530

© 2012 Lippincott Williams & Wilkins, Inc.