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.
Phase:
Phase 2
Details
Lead Sponsor:
Yale University
Collaborators:
Augusta University Penn State University University of California, San Francisco University of North Carolina University of Oklahoma University of Pennsylvania