Recruitment challenges of a multicenter randomized controlled varicocelectomy trial

Abstract

Objective: To review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy versus intrauterine insemination (IUI) for treatment of male infertility and to suggest means for improving future study recruitment.

Design: Survey of Reproductive Medicine Network (RMN) participating sites.

Setting: Reproductive Medicine Network.

Patient(s): None.

Intervention(s): None.

Main outcome measure(s): Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails.

Result(s): This study screened seven and enrolled three couples, with the first couple randomized on June 30, 2010. The study was subsequently stopped on March 30, 2011. The following themes were cited most frequently by sites and therefore determined to be most likely to have played a role in suboptimal recruitment: [1] men must be screened at the beginning of a couple's infertility evaluation, [2] inclusion of infertile women who had failed previous fertility interventions appeared to be associated with the couple's intolerance of a placebo arm, and [3] an apparent bias against the use of unstimulated IUI cycles indicated a prejudicial preference for surgical intervention in the male partner.

Conclusion(s): Improved recruitment may be realized through screening infertile men as early as possible while minimizing study-related time commitments. Focused patient education may promote improved equipoise and acceptance of a placebo arm in male infertility studies. Creative approaches to implementing varicocelectomy trials must be considered in addition to having a network of motivated researchers who carry a high volume of possible study participants because very large numbers may need to be screened to complete the clinical trial enrollment.

Trial registration: ClinicalTrials.gov NCT00767338.

Figure 1. Varicocelectomy Flow Chart

Figure 2. RMN Recruitment Flowchart