Overview

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