Protocol for developing a core outcome set for male infertility research: an international consensus development study

Abstract

Abstract: Male infertility affects millions of men world-wide, and many different treatments have been proposed for this. How effective these treatments are can only be truly understood if clinical trials report the same outcomes, which are measured and defined in the same way. The protocol described here sets out the process by which we will develop a multinational, multi professional driven ‘core outcome set’ for future male infertility research. Currently, there is no agreed consensus on what outcomes clinical trials should collect and report when evaluating treatments for male infertility. This means that when new trials are published to evaluate a treatment for male infertility, researchers and clinicians may not be able to fully understand its potential benefit for patients, in the context of previously published research. A core outcome set allows researchers to measure a consistent set of clinical endpoints. By developing a core outcome set for male infertility research, we hope to harmonize the outcomes collected and published in future research. We hope this will better inform clinical decision-making for healthcare professionals and improve the care patients receive.