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

Repromed

Status and phase

Completed

Phase 3

Conditions

Infertility, Male

Oxidative Stress

Treatments

Drug: Menevit anti-oxidant

Study type

Interventional

Funder types

Other

Identifiers

NCT00100269

RCHDW002

Details and patient eligibility

About

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.

Full description

Men will be screened for oxidative stress (free radical) related damage to their sperm. This will include screening for lipid peroxidation of sperm using the LPO-586 assay, HOST test and for sperm DNA fragmentation using the Tunel technique. Those men found to have free radical related damage will be enrolled in a randomized control trial in which they will receive either the Menevit anti-oxidant or placebo (in a 2:1 randomization ratio respectively). The Menevit anti-oxidant is a capsule containing several different anti-oxidants, taken orally once per day. The placebo is identical in appearance and taste. After 3 months of Menevit/placebo the female partners of these men will undergo an IVF oocyte retrieval operation and embryo transfer. Pregnancy rates and embryo quality will be compared between groups. Changes in semen characteristics (count, motility, morphology, membrane integrity) and lipid peroxidation (LPO-586) plus sperm DNA fragmentation (Tunel assay) will be assessed at trial entry, 6 weeks and 3 months. Comparisons between the patients embryo quality in the IVF cycle immediately before and during the Menevit trial will also be compared when possible

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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