- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100269
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
-
-
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
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
- Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
- Agarwal A, Nallella KP, Allamaneni SS, Said TM. Role of antioxidants in treatment of male infertility: an overview of the literature. Reprod Biomed Online. 2004 Jun;8(6):616-27. doi: 10.1016/s1472-6483(10)61641-0.
- Aitken RJ, Baker MA. Oxidative stress and male reproductive biology. Reprod Fertil Dev. 2004;16(5):581-8. doi: 10.10371/RD03089.
- Aitken RJ, Gordon E, Harkiss D, Twigg JP, Milne P, Jennings Z, Irvine DS. Relative impact of oxidative stress on the functional competence and genomic integrity of human spermatozoa. Biol Reprod. 1998 Nov;59(5):1037-46. doi: 10.1095/biolreprod59.5.1037.
- Henkel R, Hajimohammad M, Stalf T, Hoogendijk C, Mehnert C, Menkveld R, Gips H, Schill WB, Kruger TF. Influence of deoxyribonucleic acid damage on fertilization and pregnancy. Fertil Steril. 2004 Apr;81(4):965-72. doi: 10.1016/j.fertnstert.2003.09.044.
- Carrell DT, Liu L, Peterson CM, Jones KP, Hatasaka HH, Erickson L, Campbell B. Sperm DNA fragmentation is increased in couples with unexplained recurrent pregnancy loss. Arch Androl. 2003 Jan-Feb;49(1):49-55. doi: 10.1080/01485010290099390.
- Gomez E, Irvine DS, Aitken RJ. Evaluation of a spectrophotometric assay for the measurement of malondialdehyde and 4-hydroxyalkenals in human spermatozoa: relationships with semen quality and sperm function. Int J Androl. 1998 Apr;21(2):81-94. doi: 10.1046/j.1365-2605.1998.00106.x.
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.
Clinical Trials on Oxidative Stress
-
University of SouthamptonEuropean Space AgencyActive, not recruiting
-
University of ThessalyActive, not recruiting
-
NestléCompleted
-
University of BirminghamCompleted
-
University of KentuckyAlltech Life Sciences Inc.Completed
-
Ganin Fertility CenterThe Cleveland Clinic; University of the Western CapeUnknown
-
Antalya Training and Research HospitalCompleted
-
Gazi UniversityCompleted
-
Chinese University of Hong KongCompleted
-
Seoul St. Mary's HospitalRural Development Administration, KoreaCompletedOxidative StressKorea, Republic of
Clinical Trials on Menevit anti-oxidant
-
Milton S. Hershey Medical CenterNational Institute on Drug Abuse (NIDA)Not yet recruitingTobacco Use | Oxidative Stress
-
Assiut UniversityCompletedAutoimmune Thyroiditis
-
Altitude Physiology ExpeditionsUniversity of EdinburghCompletedAcute Mountain SicknessUnited Kingdom
-
Light Sciences LLCTerminatedMacular Degeneration | Choroidal NeovascularizationUnited States
-
Woman's Health University Hospital, EgyptCompletedOilgohydramniosEgypt
-
Brock UniversityOntario Neurotrauma FoundationCompletedDepression | Cognitive Impairment | Neuropathic Pain | Autonomic Dysfunction | Somatic NeuropathyCanada
-
Walter Reed National Military Medical CenterCompletedType 2 DiabetesUnited States
-
Inonu UniversityCompletedMorbid Obesity | Oxidative StressTurkey
-
Derming SRLUniversity of BolognaCompleted