Males, Antioxidants, and Infertility Trial

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

DRUG

Antioxidant Supplement

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

• University of North Carolina

  collaborator OTHER

• Augusta University

  collaborator OTHER

• Penn State University

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• Esther Eisenberg, MD · Eunice Kennedy Shriver National Institue of Child Health and Human Development

• Nanette Santoro, MD · University of Colorado, Denver

• Anne Z Steiner, MD · University of North Carolina

• Michael P Diamond, MD · Augusta University

• Richard S Legro, MD · Penn State University

• Marcelle Cedars, MD · University of California, San Francisco

• Karl R Hansen, MD · University of Oklahoma

• Christos Coutifaris, MD · University of Pennsylvania

• Heping Zhang, PhD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-31

Primary Completion

2018-06-11

Completion

2018-12-31

Countries

• United States

Study Locations