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

May 1, 2006 updated by: Repromed

A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5065
        • Repromed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Embryo quality (morphology score, progression to blastocyst rates, number of embryos available for freezing/transfer per cycle)
Embryo quality is a good measure of pregnancy potential and is also an indicator of sperm DNA integrity, making it the ideal primary endpoint.

Secondary Outcome Measures

Outcome Measure
sperm DNA fragmentation
sperm count
sperm motility (total motile sperm per ejaculate)
sperm morphology
sperm membrane integrity (as assessed by hypo-osmolar swelling test)
levels of sperm lipid peroxidation (LPO-586 assay)
retrospective comparison of embryo quality between the Menevit IVF cycle and the preceding non-Menevit IVF cycle.
miscarriage rate (clinical and biochemical)
clinical pregnancy rates (number of fetal hearts seen on first trimester scan)
adverse side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repromed

Investigators

  • Principal Investigator: Kelton P Tremellen, MB BS (Hons) PhD, Repromed, University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

December 27, 2004

First Submitted That Met QC Criteria

December 27, 2004

First Posted (Estimate)

December 28, 2004

Study Record Updates

Last Update Posted (Estimate)

May 3, 2006

Last Update Submitted That Met QC Criteria

May 1, 2006

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCHDW002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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