Design and analysis of randomized clinical trials of embryo diagnostics: phase 3

Randomized controlled trials represent the strongest method for evaluating the effectiveness and safety of embryo diagnostics, provided that they are designed and conducted to a high standard. Many design decisions are complex and contentious. We describe key considerations in the design of embryo diagnostic trials, including choice of outcome, timing of randomization, and strategies for data analysis, describing the implications of different decisions. Thirty recommendations for the design and conduct of randomized controlled trials of embryo diagnostics are supplied.