Reflections on the Challenges of Infertility-Based Randomized Controlled Trials

Abstract

Successful randomized clinical trials (RCTs) are considered the gold standard in clinical research, but require sufficient recruitment, adequate sample size, appropriate participant selection, pre-defined outcomes, and transparent reporting of outcomes. Infertility-related RCTs harbor a unique set of logistical and ethical challenges, as highlighted by our multicenter RCT evaluating clinical differences in low-dose versus high-dose gonadotropin in poor responders undergoing assisted reproductive technology. This is a descriptive review and reflections of frequent difficulties faced by researchers while conducting RCTs and their implications, as well as potential solutions when conducting this type of research. While our RCT in poor responders undergoing in vitro fertilization (IVF) failed to demonstrate superior clinical outcomes with high-dose versus low-dose gonadotropins, the study was significantly underpowered. Despite this, our results help underscore universal difficulties in the recruitment, conduct, and publication of RCTs. We review our challenges and suggest available tools to aid in recruitment and enhance trial completion. Recruitment, conducting, and publishing an RCT have numerous challenges, particularly in an infertile population, which are not unique to our study. Addressing these barriers, despite the shortcomings, provides significant value to the scientific community.