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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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) on sperm function, embryo quality and pregnancy rates in an in vitro fertilization (IVF) setting.

Detailed Summary: 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
Sponsor: Repromed

Current Primary Outcome:

  • 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.


Original Primary Outcome: pregnancy (viable pregnancy noted on first trimeter ultrasound examination)

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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)
  • embryo quality (morphology score, % progression to blastocyst, embryo number avaliable for freezing)
  • miscarriage rate (clinical and biochemical)
  • adverse side effects


Information By: Repromed

Dates:
Date Received: December 27, 2004
Date Started: December 2004
Date Completion: March 2006
Last Updated: May 1, 2006
Last Verified: June 2005