Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxidative stress related damage to sperm is believed to be a major cause of male infertility. The object of the Menevit study is to investigate the role of a novel anti-oxidant preparation (Menevit) on sperm function, embryo quality and pregnancy rates in an in vitro fertilization (IVF) setting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repromed
• Treatments: Antioxidants

Criteria

Inclusion Criteria:

• Evidence of oxidative stress to sperm on LPO-586 assay or poor HOST result or clinical evidence for oxidative stress (heavy smoker, varicocele, poor motility in the abscence of anti-sperm antibodies etc)

• Evidence of significant sperm DNA damage (25% or more DNA fragmentation as assessed by Tunel assay).

• Female partner willing to undergo IVF treatment within 3 months of starting Menevit trial

Exclusion Criteria:

• Female partner 40 years of age or older at trial entry.

• Significantly reduced ovarian reserve in female partner (day 3-5 FSH > 10 iu/L if no prior IVF cycle or less than 5 oocytes on a prior IVF cycle.

• Sperm count below 0.5 million per ml (impossible to conduct all sperm function assays