Journal article
A Randomized Trial to Evaluate the Effects of Folic Acid and Zinc Supplementation on Male Fertility and Livebirth: Design and Baseline Characteristics
American journal of epidemiology, Vol.189(1), pp.8-26
2020
DOI: 10.1093/aje/kwz217
PMCID: PMC8204144
PMID: 31712803
Abstract
Abstract
The Folic Acid and Zinc Supplementation Trial (FAZST) was a multicenter, double-blind, block-randomized, placebo-controlled trial to determine whether folic acid and zinc supplementation in men improves semen quality and increases livebirth rate among couples seeking infertility treatment (2013–2017). Eligible men were aged 18 years or older with female partners aged 18–45 years, seeking infertility treatment. Men were randomized (1:1) to 5 mg folic acid and 30 mg elemental zinc daily or matching placebo for 6 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, and female partners were passively followed for a minimum of 9 months. Women who conceived were followed throughout pregnancy. Overall, 2,370 men were randomized during 2013–2017 (1,185 folic acid and zinc, 1,185 placebo); they had a mean age of 33 years and body mass index (weight (kg)/height (m)2) of 29.8. Most participants were 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. Here we describe the study design, recruitment, data collection, lessons learned, and baseline participant characteristics.
Details
- Title: Subtitle
- A Randomized Trial to Evaluate the Effects of Folic Acid and Zinc Supplementation on Male Fertility and Livebirth: Design and Baseline Characteristics
- Creators
- Enrique F Schisterman - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentTraci Clemons - EmmesC Matthew Peterson - University of UtahErica Johnstone - University of UtahAhmad O Hammoud - IVF Michigan Fertility Centers, Bloomfield Hills, MichiganDenise Lamb - University of UtahDouglas T Carrell - University of UtahNeil J Perkins - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentLindsey A Sjaarda - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentBradley J Van Voorhis - Roy J. and Lucille A. Carver College of MedicineGinny Ryan - Roy J. and Lucille A. Carver College of MedicineKaren Summers - Roy J. and Lucille A. Carver College of MedicineBruce Campbell - Colorado Center for Reproductive MedicineJared Robins - Northwestern UniversityKayla Chaney - EmmesJames L Mills - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentPauline Mendola - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentZhen Chen - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentElizabeth A DeVilbiss - Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentSunni L Mumford - Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland
- Resource Type
- Journal article
- Publication Details
- American journal of epidemiology, Vol.189(1), pp.8-26
- Publisher
- Oxford University Press
- DOI
- 10.1093/aje/kwz217
- PMID
- 31712803
- PMCID
- PMC8204144
- ISSN
- 0002-9262
- eISSN
- 1476-6256
- Grant note
- name: Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, award: HHSN275201200007C, HHSN275201300026I; DOI: 10.13039/100000002, name: NIH
- Language
- English
- Date published
- 2020
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9984318222902771
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