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.
Phase:
N/A
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)