Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
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ClinicalTrials.gov Identifier: NCT00100269 |
Recruitment Status
:
Completed
First Posted
: December 28, 2004
Last Update Posted
: May 3, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility, Male Oxidative Stress | Drug: Menevit anti-oxidant | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility |
Study Start Date : | December 2004 |
Study Completion Date : | March 2006 |

- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100269
Australia, South Australia | |
Repromed | |
Adelaide, South Australia, Australia, 5065 |
Principal Investigator: | Kelton P Tremellen, MB BS (Hons) PhD | Repromed, University of Adelaide |
Publications:
ClinicalTrials.gov Identifier: | NCT00100269 History of Changes |
Other Study ID Numbers: |
RCHDW002 |
First Posted: | December 28, 2004 Key Record Dates |
Last Update Posted: | May 3, 2006 |
Last Verified: | June 2005 |
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 Protective Agents Physiological Effects of Drugs |