CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 171 enrolled
Drug / intervention
Antioxidant Supplement +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02421887
NCT02421887Phase 2Completed

Males, Antioxidants, and Infertility (MOXI) Trial

Yale University·interventional·Posted Apr 21, 2015·Updated Sep 4, 2019

In Brief

A Phase 2 clinical trial evaluating Antioxidant Supplement and Placebo for Male Infertility. Completed, enrolled 171 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 21, 2015
Enrollment StartDec 1, 2015
Primary CompletionJun 11, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.2 years ago

Interventions

Antioxidant Supplementdrug

An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine

Placeboother

Placebo