Recruitment challenges of a multicenter randomized controlled varicocelectomy trial.

Area of Science:

• Reproductive Medicine
• Clinical Trials
• Male Infertility

Background:

• Suboptimal recruitment hinders randomized controlled trials (RCTs) for male infertility treatments.
• Varicocelectomy and intrauterine insemination (IUI) are common interventions, but trial enrollment remains a challenge.

Purpose of the Study:

• To identify reasons for poor recruitment in a varicocelectomy versus IUI RCT.
• To propose strategies for enhancing future clinical trial enrollment in male infertility research.

Main Methods:

• A survey was distributed to participating sites within the Reproductive Medicine Network (RMN).
• The survey aimed to identify factors contributing to inadequate participant recruitment and suggest improvements for varicocelectomy trials.

Main Results:

• The study screened seven couples and enrolled three, with the trial stopped prematurely.
• Key recruitment barriers included the timing of male screening, patient intolerance of placebo arms due to prior fertility intervention failures, and bias against unstimulated IUI favoring surgical intervention.

Conclusions:

• Early screening of infertile men and minimizing study burden can improve recruitment.
• Patient education is crucial for fostering equipoise and acceptance of placebo arms.
• Varicocelectomy trial designs require creative approaches and a robust network of motivated researchers to overcome low enrollment rates.