Folic Acid and Zinc Supplementation Trial (FAZST)

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.

Conditions

• Pregnancy
• Live Birth
• Spontaneous Abortion

Interventions

DIETARY_SUPPLEMENT

5 mg folic acid and 30 mg elemental zinc

DRUG

Placebo Comparator: Placebo

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  lead NIH

Principal Investigators

• Enrique F. Schisterman, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Sunni L. Mumford, PhD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• C. Matthew Peterson, MD · University of Utah

• Jared C. Robins, MD · Northwestern University

• Ginny L. Ryan, MD, MA · University of Iowa

• Bradley J. Van Voorhis, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-06-30

Primary Completion

2019-06-30

Completion

2019-06-30

Countries

• United States

Study Locations