Status:
COMPLETED
Folic Acid and Zinc Supplementation Trial (FAZST)
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Live Birth
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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 ...
Detailed Description
Two micronutrients fundamental to the process of spermatogenesis, folic acid (folate) and zinc, are of particular interest for fertility as they are of low cost and wide availability. Though the evide...
Eligibility Criteria
Inclusion
- Couples
- Heterosexual couples in a committed relationship with a female partner aged 18-45 years and male partner aged 18 years and older attempting to conceive and seeking assisted reproduction at participating fertility clinics.
- Couples actively trying to conceive.
- Couples who are planning ovulation induction (OI), natural fertility optimization methods, or intrauterine insemination (IUI) should be willing to be on the study dietary supplement for at least 3 weeks before starting the next assisted reproduction cycle.Women with regular periods may initiate their fertility therapy at the start of the woman's menstrual cycle following randomization if randomization occurred within the first 10 days of the cycle, but must wait one menstrual cycle if the visit occurred after day 10 of the cycle). For women with irregular periods or amenorrhea, the male must be on the study supplement for 3 weeks prior to initiation of any ovulation induction medication (e.g., clomid, letrozole, gonadotropins).
- Couples
Exclusion
- Female partner unwilling to participate (e.g., no abstraction of her assisted fertility treatment record or unwilling to complete baseline visit).
- Couples using donor, cryopreserved sperm, or sperm obtained via microsurgical or percutaneous epididymal sperm aspiration.
- Couples attempting to conceive with a gestational carrier (surrogate).
- Positive urine pregnancy test at screening.
- Male Inclusion Criteria:
- Willing to provide semen samples according to the proposed schedule at baseline, 2, 4, and 6 months of follow-up.
- Able to complete regular study questionnaires and daily journals aimed at capturing ejaculation, sexual intercourse and lifestyle factors considered to affect male fecundity (e.g., cigarette smoking, fever, high temperature environment and other environmental exposures) and other data collection instruments (e.g., physical activity, food frequency questionnaire, stress).
- Male
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
2370 Patients enrolled
Trial Details
Trial ID
NCT01857310
Start Date
June 1 2013
End Date
June 1 2019
Last Update
November 19 2020
Active Locations (4)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Iowa
Iowa City, Iowa, United States, 52242
3
Center for Reproductive Medicine
Minneapolis, Minnesota, United States, 55407
4
University of Utah
Salt Lake City, Utah, United States, 84132