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EB Research - Reproductive Epidemiology
Folic Acid and Zinc Supplementation Trial
Study Objective
The primary objective of the study is to assess the efficacy of folic acid and zinc supplementation in males on semen quality and fertility treatment outcomes (i.e., live birth rate) among couples seeking fertility treatment. A double-blind, placebo-controlled randomized trial of folic acid and zinc supplementation will be conducted. Following a screening/randomization visit, participants will return at baseline, 2, 4, and 6 months.
Background
Infertility affects 10 to 15% of couples attempting to conceive. Male factor subfertility plays a role in about 50% of subfertile couples, with largely unknown etiology. An intervention with even a small absolute effect on any component of male factor infertility has tremendous implications at the population level because of the large potential attributable benefit. Two micronutrients fundamental to the process of spermatogenesis, folate and zinc, are of particular interest as they offer a potential low cost and widely available treatment. Though the evidence has been inconsistent, small randomized trials and observational studies show that folate and zinc have biologically plausible effects on spermatogenesis and improved semen parameters. These results support the potential benefits of folate on spermatogenesis, and suggest that supplementation with folate and zinc may improve semen quality, and perhaps, assisted reproductive technology (ART) outcomes.
Study Design & Progress
This is a multi-center, double-blind, randomized placebo-controlled trial to assess the effects of folic acid and zinc supplementation on semen quality and fertility treatment outcomes among 2400 male partners of couples seeking fertility treatment. The primary objective of the study is to assess the efficacy of folic acid and zinc sulfate supplementation in males on semen quality and fertility treatment outcomes (i.e., live birth rate) among couples seeking fertility treatment. Following a screening visit, participants will return at baseline, 2, 4, and 6 months. FAZST will recruit a total of 2400 participants who will be randomized to either study supplements (5 mg folic acid and 30 mg elemental zinc) or matching placebo. The trial is ongoing and recruitment is expected to begin May 2013 and will be completed in 2017.
Clinical Sites
- Utah: Ahmad Hammoud
- Minnesota: Bruce Campbell
- Data Coordinating Center: Traci Clemons
Principal Investigators
Enrique F. Schisterman, Ph.D. & Sunni L. Mumford, Ph.D.
DESPR Collaborators
- Katherine Ahrens, Ph.D.
- Ruzong Fan, Ph.D.
- Pauline Mendola, Ph.D.
- James Mills, M.D., M.S.
- Kerri Kissell, M.D.
- Neil Perkins, Ph.D.
- Anna Pollack, Ph.D., M.P.H.
- Ankita Prasad, B.A.
- Karen Schliep, Ph.D., M.S.P.H
- Edwina Yeung, Ph.D.
- Cuilin Zhang, M.D., M.P.H., Ph.D.