Status:
COMPLETED
Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Lead Sponsor:
Repromed
Conditions:
Infertility, Male
Oxidative Stress
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) o...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00100269
Start Date
December 1 2004
End Date
March 1 2006
Last Update
May 3 2006
Active Locations (1)
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1
Repromed
Adelaide, South Australia, Australia, 5065