Elsevier

Fertility and Sterility

Volume 102, Issue 4, October 2014, Pages 952-959.e15
Fertility and Sterility

ASRM pages
Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement

https://doi.org/10.1016/j.fertnstert.2014.08.002Get rights and content
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Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which creates a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant after ≥20 weeks' gestation) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.

Key Words

Infertility trial
CONSORT
reporting
IMPRINT
modification

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Disclosures are listed in within the text if the article.

This study, participants' travel and their attendance to the meeting was funded from by the National Clinical Trial Base in TCM, National Key Discipline/Specialty, Longjiang Scholars' Program, and Innovative Team of Heilongjiang Province Universities.

This article has not been externally peer reviewed.

This article is being published simultaneously in Human Reproduction.

Conference Chairs: Richard S. Legro (USA) and Xiaoke Wu (China). Scientific Committee: Kurt T. Barnhart (USA), Cynthia Farquhar (New Zealand), Bart C. J. M. Fauser (the Netherlands), Ben Mol (Australia).

Reprint requests: Xiaoke Wu, M.D., Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin 150040, People's Republic of China (E-mail: [email protected]).