NCT02421887

Males, Antioxidants, and Infertility Trial

Males, Antioxidants, and Infertility (MOXI) Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Male Infertility

Interventions

Type	Name	Description
DRUG	Antioxidant Supplement	An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2018-06-11
• Completion: 2018-12-01
• First posted: 2015-04-21
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

10 sites across 1 country: United States