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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00100269




Registration number
NCT00100269
Ethics application status
Date submitted
27/12/2004
Date registered
28/12/2004
Date last updated
3/05/2006

Titles & IDs
Public title
Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Scientific title
A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Secondary ID [1] 0 0
RCHDW002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility, Male 0 0
Oxidative Stress 0 0
Condition category
Condition code
Reproductive Health and Childbirth 0 0 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Embryo quality (morphology score, progression to blastocyst rates, number of embryos available for freezing/transfer per cycle)
Timepoint [1] 0 0
Primary outcome [2] 0 0
Embryo quality is a good measure of pregnancy potential and is also an indicator of sperm DNA integrity, making it the ideal primary endpoint.
Timepoint [2] 0 0
Secondary outcome [1] 0 0
sperm DNA fragmentation
Timepoint [1] 0 0
Secondary outcome [2] 0 0
sperm count
Timepoint [2] 0 0
Secondary outcome [3] 0 0
sperm motility (total motile sperm per ejaculate)
Timepoint [3] 0 0
Secondary outcome [4] 0 0
sperm morphology
Timepoint [4] 0 0
Secondary outcome [5] 0 0
sperm membrane integrity (as assessed by hypo-osmolar swelling test)
Timepoint [5] 0 0
Secondary outcome [6] 0 0
levels of sperm lipid peroxidation (LPO-586 assay)
Timepoint [6] 0 0
Secondary outcome [7] 0 0
retrospective comparison of embryo quality between the Menevit IVF cycle and the preceding non-Menevit IVF cycle.
Timepoint [7] 0 0
Secondary outcome [8] 0 0
miscarriage rate (clinical and biochemical)
Timepoint [8] 0 0
Secondary outcome [9] 0 0
clinical pregnancy rates (number of fetal hearts seen on first trimester scan)
Timepoint [9] 0 0
Secondary outcome [10] 0 0
adverse side effects
Timepoint [10] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Repromed - Adelaide
Recruitment postcode(s) [1] 0 0
5065 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Repromed
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00100269
Trial related presentations / publications
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.
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.
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Kelton P Tremellen, MB BS (Hons) PhD
Address 0 0
Repromed, University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00100269