DATA COORDINATING CENTER FOR THE IDEAL FERTILITY STUDY

The Emmes Company, Llc, Rockville MD

Investigators

Abstract

The Epidemiology Branch and Division are currently inviting female partners of participants in the Folic Acid and Zinc Supplementation Trials (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 proposed initiative, which includes additional detailed follow-up (both questionnaires and biospecimen collection) to the female partners of the Folic Acid and Zinc Supplementation Trial (FAZST), will involve a Trial Coordinating Center that is responsible for recruitment and retention of the female partners, and the Data Coordinating Center that is responsible for overall data management and the web-based data collection system. 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 16 months which will support the study through the end of recruitment, as well as a detailed report of the recruitment efforts which will form the basis of a study design paper to be submitted for publication.