Males, Antioxidants, and Infertility Trial
Completed · Phase 2 · Has a placebo group
Conditions studied: Male Infertility
In brief
The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, resulting in higher fertilization rates and improved embryo development, leading to higher pregnancy and live birth rates. Findings from this research will be significant in that they will likely lead to an effective, non-hormonal treatment modality for male infertility. An effective treatment for men would also reduce the treatment burden on the female partner, lower costs, and provide effective alternatives to couples with religious or ethical contraindications to ART (Assisted Reproductive Technology). If antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity, they could allow for couples with male factor infertility to use less intensive therapies such as intrauterine insemination. Male fertility specialists currently prescribe antioxidants based on the limited data supporting their use. A negative finding, lack of any benefit, would also alter current treatment of infertile males.
Key facts
- Study ID
- NCT02421887
- Run by
- Yale University
- People needed
- 171
- Starts
- 2015-12-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2019-09-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- Couple:
- Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
- Planning in vitro fertilization in the next 6 months
- Male:
- Sperm concentration < 5 million/mL on screening semen analysis
- Current use of a medication or drug that would affect reproductive function or metabolism (see Appendix C for list)
- Current multivitamin or herb use (requires 1 month wash-out)
- Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
- Current use of anticoagulants
- Untreated hypothyroidism
- Uncontrolled diabetes mellitus
- Female:
- History of surgically or medically confirmed moderate or severe endometriosis
- Body mass index >35 kg/m2
- Currently pregnant
- History of polycystic ovarian syndrome
- Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
- History of systemic chemotherapy or pelvic radiation
- Current use of a medication or drug that would affect reproductive function or metabolism
Where it is running
- Keck School of Medicine of University of Southern California — Los Angeles, California, United States
- University of California San Francisco — San Francisco, California, United States
- Stanford University — Sunnyvale, California, United States
- Augusta University — Augusta, Georgia, United States
- Wayne State University — Southfield, Michigan, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Carolinas Medical Center - Women's Institute — Charlotte, North Carolina, United States
- University of Oklahoma — Oklahoma City, Oklahoma, United States
- Pennsylvania State University — Hershey, Pennsylvania, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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