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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 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.
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.
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
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01857310
The ClinicalTrials.gov registry entry for NCT01857310 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator: Placebo is the first listed.
NCT01857310 reports 0 study locations.
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.
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