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

      Harbin Consensus Conference Workshop Group
      Fertility and sterility
      CONSORT, IMPRINT, Infertility trial, modification, reporting

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          Abstract

          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.

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          Author and article information

          Journal
          Fertil. Steril.
          Fertility and sterility
          1556-5653
          0015-0282
          Oct 2014
          : 102
          : 4
          Article
          S0015-0282(14)02028-7
          10.1016/j.fertnstert.2014.08.002
          25225072
          ba5cf4f2-fdaf-426a-ba00-9e476210c2c3
          Copyright © 2014 The Author. Published by Elsevier Inc. All rights reserved.
          History

          CONSORT,IMPRINT,Infertility trial,modification,reporting
          CONSORT, IMPRINT, Infertility trial, modification, reporting

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