Recruitment challenges of a multicenter randomized controlled varicocelectomy trial

STUDY OBJECTIVE: To review reasons for suboptimal recruitment for a randomized controlled trial (RCT) of varicocelectomy vs. intrauterine insemination for treatment of male infertility, and suggest means to improve future study recruitment. DESIGN: A survey of RMN participating sites. SETTING: The Reproductive Medicine Network. PATIENTS: N/A INTERVENTIONS: N/A MAIN OUTCOME MEASURES: Ascertain reasons for inadequate recruitment and suggest improvements for future varicocelectomy trails. RESULTS: This study screened 7 and enrolled 3 couples with the first couple randomized on 6/30/2010. The study was subsequently stopped on 03/30/2011. 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 have failed previous fertility interventions appeared to be associated with couple intolerance of a placebo arm, and (3) there appeared to be bias against the use of unstimulated IUI cycles, indicating a prejudicial preference for surgical intervention in the male partner. CONCLUSIONS: 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. Lastly, 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, as screening of very large numbers may be needed to complete clinical trial enrollment. Clinicaltrials.gov: NCT00767338