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

This study has been completed.
Sponsor:
Information provided by:
Repromed
ClinicalTrials.gov Identifier:
NCT00100269
First received: December 27, 2004
Last updated: May 1, 2006
Last verified: June 2005
  Purpose

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.


Condition Intervention Phase
Infertility, Male
Oxidative Stress
Drug: Menevit anti-oxidant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Resource links provided by NLM:


Further study details as provided by Repromed:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 60
Study Start Date: December 2004
Estimated Study Completion Date: March 2006
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100269

Locations
Australia, South Australia
Repromed
Adelaide, South Australia, Australia, 5065
Sponsors and Collaborators
Repromed
Investigators
Principal Investigator: Kelton P Tremellen, MB BS (Hons) PhD Repromed, University of Adelaide
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00100269     History of Changes
Other Study ID Numbers: RCHDW002
Study First Received: December 27, 2004
Last Updated: May 1, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Repromed:
Male infertility
sperm
pregnancy
IVF (in vitro fertilisation)
oxidative stress
free radicals
DNA damage

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014