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NCT01857310 · ClinicalTrials.gov registry record · NA
Folic Acid and Zinc Supplementation Trial (FAZST)
A NA study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- NA
- Development phase
- 2,370
- Enrollment target
NCT01857310: Completed NA study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01857310 is a NA study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 2,370 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01857310, a NA study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- NA
- Development phase
- 2,370 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Based on hospital delivery records
Interventions
- DRUG Placebo Comparator: Placebo
- DIETARY_SUPPLEMENT 5 mg folic acid and 30 mg elemental zinc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,370 participants |
| Start Date | 2013-06 |
| Est. Completion | 2019-06 |
| Phase | NA |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT01857310 record still lists
NCT01857310 is an interventional study that assigns participants to a tested intervention. Its 2,370 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (69% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator: Placebo is the first listed.
NCT01857310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01857310 about?
NCT01857310 is a clinical study titled "Folic Acid and Zinc Supplementation Trial (FAZST)". 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 object...
What is the current status of trial NCT01857310?
This trial is currently completed. It is a NA study. The enrollment target is 2,370 participants. The study started on 2013-06. Estimated completion is 2019-06.
What interventions are being tested in trial NCT01857310?
The interventions under investigation include: Placebo Comparator: Placebo (DRUG), 5 mg folic acid and 30 mg elemental zinc (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01857310?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01857310's enrollment target sits among peer trials
2,370 46th of 2000 higher than 1,955 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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