Improving the Reporting of Clinical Trials of Infertility Treatment (IMPRINT): explanation and elaboration of the modification of the CONSORT statement

摘要

Infertility is a common disability, and is listed by the World Health Organization as the fifth leading serious disability among populations under the age of 60 years. Effective therapies exist, but evidence-based options are uncommon. Clinical trials in infertility treatment lack uniform guidelines for reporting methodology and results. Clinical trials in infertility are unique in that they usually involve, at minimum, two individuals who may receive or participate in treatment, i.e., a woman and a man, and if treatment is successful, a third individual is followed in the trial, i.e., an infant, who is also the desired outcome of the treatment. This tripartite involvement of three unique humans in a clinical trial is unprecedented in other clinical trials, and the Consolidated Standards of Reporting Trials (CONSORT) guidelines leave several areas of uncertainty regarding what to report with multiple individuals involved. Two of the individuals, the woman seeking pregnancy and the infant, have been classified ethically as vulnerable populations requiring careful collection of all adverse events, including congenital anomaly rates. Participants may experience varied risk and benefit from the trial; for example, multiple pregnancy may be desired by the father, feared by the mother, and fatal to the infant. The outcome of primary interest to participants, i.e., a live birth, is separated from the actual treatment by 9 months and subject to confounding influences from other factors. These myriad issues lead to incomplete and inconsistent reporting of results. We developed this modification to the CONSORT statement, which we describe and justify in this document, to report the items of vital interest to infertile couples, clinicians, and the public that should be collected in an infertility trial.