Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00100269