The healthy men study: design and recruitment considerations for environmental epiderniologic studies in male reproductive health

Objective: To describe study design, conduct and response, and participant characteristics. Design: Prospective cohort study. Setting: Participants were male partners of women who were enrolled in a community-based prospective cohort study of drinking water disinfection by-products and pregnancy health. Patient(s): Two hundred thirty presumed fertile men recruited from 3 study sites in the United States. Intervention(s): Men completed a telephone interview about demographics, health history, and exposures and provided a semen sample that was express mailed to the study laboratory. Main Outcome Measure(s): Response and participation rates, participant demographics, and lifestyle exposures. Result(s): We obtained a high participation rate (84%) among men who were located, but a low overall response rate (25%). Participants were more likely to be white, more highly educated, be married, and have a higher household income than the underlying study cohort. Conclusion(s): Our multisite study design may be applicable to the study of community environmental factors and reproductive health of men. Our design was efficient in that men from geographically disparate sites could be recruited, a semen sample was collected at home, and a telephone interview was conducted from a central study site. Despite these design features, the low response rates may suggest selection bias that can be addressed partially in the analysis. (Fertil Steril (R) 2007;87:554-64. (c) 2007 by American Society for Reproductive Medicine.)