MEASUREMENT OF OPIOIDS, DIETARY FACTORS, AND GENETICS IN THE FAZST/IDEAL STUDIES

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The Folic Acid and Zinc Supplementation Trial (FAZST) is a multi-center, double-blind, randomized placebo-controlled trial to assess the effects of follc acid and zinc supplementation among male partners of couples seeking assisted reproduction, on the trial's primary outcomes of semen quality and live birth. Male participants were randomized equally (1:1) either to active study supplement (combined 5 mg folic acid and 30 mg elemental zinc) or to matching placebo. The study intervention continued for 6 months from randomization, and male participants completed in-person study visits, which included blood, urine, and semen collection, at baseline, 2, 4, and 6 months. Female partners provided biospecimens at baseline and questionnaire data, and clinical outcomes were followed through chart abstraction. Trial recruitment was completed in December 2017, with a total of 2372 couples enrolled. The Impact of Diet, Exercise and Lifestyle (IDEAL) Fertility Study involves additional detailed follow-up on a subset of the female partners. A large biospecimen repository is available for analysis and offers a good platform for testing multiple hypotheses. This task order is for the analysis of stored biospecimens in the FAZST/IDEAL studies. The work of this task order to measure zinc and markers of folate metabolism, inflammatory markers, lsoprostanes, endocrine system markers, and metabolic markers will allow DIPHR to answer novel research questions in conjunction with the extensive data already collected in the FAZST/IDEAL studies