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Reporting multiple cycles in trials on medically assisted reproduction.

Irma Scholten1, Miriam Braakhekke1, Jacqueline Limpens2

  • 1Center for Reproductive Medicine, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

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Summary

Most medically assisted reproduction (MAR) trials, particularly IVF studies, fail to report on multiple cycles. This limits their clinical significance, as cumulative pregnancy rates are crucial for couples undergoing fertility treatments.

Keywords:
cumulative pregnancy ratemultiple cyclesrandomized clinical trials

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Area of Science:

  • Reproductive Medicine
  • Clinical Trials Methodology

Background:

  • Medically assisted reproduction (MAR) trials should reflect clinical practice by assessing outcomes over multiple cycles.
  • Cumulative pregnancy rates are essential for evaluating the overall effectiveness of MAR treatments for couples.

Purpose of the Study:

  • To evaluate the extent to which multiple cycles are reported in randomized controlled trials (RCTs) for MAR.
  • To identify factors influencing the reporting of multiple cycles in MAR research.

Main Methods:

  • A systematic sample of 253 MAR RCTs published across four time periods in 11 journals was analyzed.
  • Trials focused on in vitro fertilization (IVF), intrauterine insemination (IUI), and ovulation induction (OI) were included.

Main Results:

  • Only 19% of MAR RCTs reported on multiple cycles, with this being more common in IUI and OI trials than IVF trials.
  • IVF trials using live birth as the primary outcome were more likely to report multiple cycles.
  • Trials comparing protocol variations were less likely to report multiple cycles.

Conclusions:

  • The majority of MAR RCTs, especially those on IVF, do not report cumulative pregnancy rates.
  • The limited reporting of multiple cycles in MAR trials restricts their clinical applicability and the perspective of couples undergoing treatment.