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Protocol for developing a core outcome set for male infertility research: an international consensus development
Michael P Rimmer1, Ruth A Howie2, Richard A Anderson1,2
1MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Human Reproduction Open
|April 11, 2022
Summary
This study aims to create a standardized core outcome set for male infertility research. This will improve the quality and interpretability of studies on male fertility treatments.
Area of Science:
- Reproductive Medicine
- Men's Health
- Clinical Trials
Background:
- Male infertility research faces challenges in design, conduct, and reporting.
- Variations in outcome measures and reporting bias hinder evidence interpretation.
- Existing general infertility core outcome sets do not address male-specific issues.
Purpose of the Study:
- To develop a minimum data set, or core outcome set, for male infertility research.
- To enhance the quality, consistency, and interpretability of male infertility studies.
- To incorporate the perspectives of individuals experiencing fertility problems.
Main Methods:
- An international steering group will guide development.
- A systematic review of randomized controlled trials will identify potential outcomes.
- Modified Delphi method and consensus development meetings will finalize the core outcome set.
Main Results:
- A systematic review will identify potential core outcomes for male infertility.
- Consensus methods will be used to refine and prioritize these outcomes.
- Standardized definitions and measurement instruments will be established.
Conclusions:
- A bespoke core outcome set is needed for male infertility research.
- This initiative will lead to more robust and clinically relevant research findings.
- The developed set will improve the design and reporting of male infertility trials.
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