A Phase 3 interventional study of Menevit anti-oxidant in Infertility, Male and Oxidative Stress, sponsored by Repromed. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-05-03.
Sponsored by Repromed · Phase 3, Interventional, and Treatment
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.
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
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with Repromed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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
This study is completed, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.