Folic Acid and Zinc Supplementation Trial (FAZST)

Completed · Not applicable · Has a placebo group

Conditions studied: Pregnancy, Live Birth, Spontaneous Abortion

In brief

The overarching goal of this trial is to determine if an intervention comprising folic acid and zinc dietary supplementation improves semen quality and indirectly fertility outcomes (i.e., live birth rate) among couples trying to conceive and seeking assisted reproduction. The following study objectives underlie successful attainment of the overarching research goal: 1. To estimate the effect of folic acid and zinc dietary supplementation on semen quality parameters, including but not limited to concentration, motility, morphology, and sperm DNA integrity, relative to the placebo group. 2. To estimate the effect of folic acid and zinc dietary supplementation on fertility treatment outcomes \[fertilization, embryo quality, implantation/human Chorionic Gonadotropin (hCG) confirmed pregnancy, clinical pregnancy, live birth\], relative to the placebo group. 3. To estimate the association between semen quality parameters, sperm DNA integrity and fertility treatment outcomes (fertilization, embryo quality, clinical pregnancy, live birth) and to identify the best combination of semen quality parameters for prediction of clinical pregnancy and live birth. 4. To estimate the effect of folic acid and zinc dietary supplementation on fertilization rates among couples undergoing assisted reproductive technology procedures, relative to the placebo group. 5. To estimate the effect of folic acid and zinc dietary supplementation on embryonic quality among couples undergoing assisted reproductive technology procedures, relative to the placebo group.

Key facts

Study ID
NCT01857310
Run by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
People needed
2370
Starts
2013-06-01
Expected to finish
2019-06-01
Last updated by the study team
2020-11-19

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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