Journal Article
A Randomized Trial to Evaluate the Effects of Folic Acid and Zinc Supplementation on Male Fertility and Live Birth: Design and Baseline Characteristics
Schisterman, EF; Clemons, T; Peterson, CM; Johnstone, E; Hammoud, AO; Lamb, D; Carrell, DT; Perkins, NJ; Sjaarda, LA; Van Voorhis, BJ; Ryan, G; Summers, K; Campbell, B; Robins, J; Chaney, K; Mills, JL; Mendola, P; Chen, Z; Devilbiss, EA; Mumford, SL
American Journal of Epidemiology
ISSN: 0002-9262
EISSN: 1476-6256
The Folic Acid and Zinc Supplementation Trial (FAZST) was a multi-center, double-blind, block-randomized, placebo-controlled trial to determine whether folic acid and zinc supplementation in men improves semen quality and increases live birth rate among couples seeking infertility treatment (2013-2017). Eligible men were ages 18 years or older with their female partners ages 18-45 seeking infertility treatment. Men were randomized (1:1) to 5 mg folic acid and 30 mg elemental zinc daily or matching placebo for six months. Randomization was stratified by site and intended infertility treatment (in vitro fertilization (IVF), non-IVF/study site, and non-IVF/outside clinic). Follow-up of men continued for 6 months, while female partners were passively followed for a minimum of nine months. Women who conceived were followed throughout pregnancy. Overall, 2,370 men were randomized between 2013-2017 (1185 folic acid and zinc, 1185 placebo), with mean age of 33 years and body mass index of 29.8. Participants were mostly white (82%), well-educated (83% with some college), and employed (72%). Participant characteristics were balanced across intervention arms. Study visits were completed by 89%, 77%, and 75% of men at months 2, 4, and 6, respectively. Herein, we describe the study design, recruitment, data collection, lessons learned, and baseline characteristics.