The Epidemiology Branch and Division are currently inviting female partners of participants in the Folic Acid and Zinc Supplementation Trial (FAZST), to participate in a study (the Impact of Diet, Exercise and Lifestyle on Fertility [IDEAL] study) that includes specific and detailed follow-up for the female partners to address these important research questions. The FAZST trial is a multi-site double-blind block-randomized placebo-controlled clinical trial to evaluate the effect of folic acid and zinc sulfate supplementation on semen quality and fertility treatment outcomes among male partners of couples seeking fertility treatment. The proposed initiative is a 16-month data supporting contract for the ?Impact of Diet Exercise And Lifestyle on Fertility: The IDEAL Fertility Study? with the University of Utah under contract HHSN275201500001C. The Data Coordinating Center (DCC) has been responsible for the overall data management and the web-based data collection system throughout the study and has worked in conjunction with the Trial Coordinating Center(TCC) that has been responsible for recruitment and retention of the female partners. The Trial Coordinating Center is a separate scope of work and is a separate non-severable contract. The objective of the proposed task order is to provide data management support for the final 200 women recruited for the study and close-out support for 16 months. As the close-out requires several specific variables to be created and extensive data cleaning, it is necessary to start the process early to ensure timeline completion in line with the FAZST trial.
