Keywords: Fertility , reproductive medicine , pregnancy outcomes , folic acid and zinc supplementation trial , semen quality , infertility , secondary infertility , pcos , male fertility
IRB Number: 00053611
Specialty: Reproductive Endocrinology and Infertility, Andrology, OB/Gyn, General
This is a multi-center, double-blinded, block randomized placebo-controlled clinical trial to assess the effects of folic acid and zinc dietary supplementation in males on semen quality and fertility rates among couples trying to conceive and seeking assisted reproduction.
The primary objective of the study is to assess the impact of folic acid and zinc dietary supplementation in males on semen quality and indirectly fertility outcomes (i.e., live birth rate) among couples attempting to conceive and seeking assisted reproduction. A double-blind, placebo-controlled block randomized trial of folic acid and zinc dietary supplementation will be conducted. Following a screening/randomization visit, participants will return at 2, 4, and 6 months. The rate of adverse events will be noted throughout the double-blind trial.