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Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Primary Purpose

Infertility, Male, Oxidative Stress

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Menevit anti-oxidant
Sponsored by
Repromed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Male infertility, sperm, pregnancy, IVF (in vitro fertilisation), oxidative stress, free radicals, DNA damage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Repromed

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 27, 2004
Last Updated
May 1, 2006
Sponsor
Repromed
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1. Study Identification

Unique Protocol Identification Number
NCT00100269
Brief Title
Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Official Title
A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Repromed

4. Oversight

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male, Oxidative Stress
Keywords
Male infertility, sperm, pregnancy, IVF (in vitro fertilisation), oxidative stress, free radicals, DNA damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Menevit anti-oxidant
Primary Outcome Measure Information:
Title
Embryo quality (morphology score, progression to blastocyst rates, number of embryos available for freezing/transfer per cycle)
Title
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 Measure Information:
Title
sperm DNA fragmentation
Title
sperm count
Title
sperm motility (total motile sperm per ejaculate)
Title
sperm morphology
Title
sperm membrane integrity (as assessed by hypo-osmolar swelling test)
Title
levels of sperm lipid peroxidation (LPO-586 assay)
Title
retrospective comparison of embryo quality between the Menevit IVF cycle and the preceding non-Menevit IVF cycle.
Title
miscarriage rate (clinical and biochemical)
Title
clinical pregnancy rates (number of fetal hearts seen on first trimester scan)
Title
adverse side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelton P Tremellen, MB BS (Hons) PhD
Organizational Affiliation
Repromed, University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Repromed
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
15367373
Citation
Aitken RJ, Baker MA. Oxidative stress and male reproductive biology. Reprod Fertil Dev. 2004;16(5):581-8. doi: 10.10371/RD03089.
Results Reference
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PubMed Identifier
9780307
Citation
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.
Results Reference
background
PubMed Identifier
12721180
Citation
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.
Results Reference
background
PubMed Identifier
15066449
Citation
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.
Results Reference
background
PubMed Identifier
12647778
Citation
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.
Results Reference
background
PubMed Identifier
15169573
Citation
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.
Results Reference
background
PubMed Identifier
9675617
Citation
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.
Results Reference
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Menevit Study: Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

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