Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development - the LIFE Study

Summary Buck Louis GM, Schisterman EF, Sweeney AM, Wilcosky TC, Gore‐Langton RE, Lynch CD, Boyd Barr D, Schrader SM, Kim S, Chen Z, Sundaram R, on behalf of the LIFE Study. Designing prospective cohort studies for assessing reproductive and developmental toxicity during sensitive windows of human reproduction and development – the LIFE Study. Paediatric and Perinatal Epidemiology 2011; 25: 413–424. The relationship between the environment and human fecundity and fertility remains virtually unstudied from a couple‐based perspective in which longitudinal exposure data and biospecimens are captured across sensitive windows. In response, we completed the LIFE Study with methodology that intended to empirically evaluate a priori purported methodological challenges: • implementation of population‐based sampling frameworks suitable for recruiting couples planning pregnancy; • obtaining environmental data across sensitive windows of reproduction and development; • home‐based biospecimen collection; and • development of a data management system for hierarchical exposome data. We used two sampling frameworks (i.e. fish/wildlife licence registry and a direct marketing database) for 16 targeted counties with presumed environmental exposures to persistent organochlorine chemicals to recruit 501 couples planning pregnancies for prospective longitudinal follow‐up while trying to conceive and throughout pregnancy. Enrolment rates varied from