NCT00100269

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 3, 2006

Status Verified

June 1, 2005

First QC Date

December 27, 2004

Last Update Submit

May 1, 2006

Conditions

Infertility, MaleOxidative Stress

Keywords

Male infertilityspermpregnancyIVF (in vitro fertilisation)oxidative stressfree radicalsDNA damage

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • sperm DNA fragmentation

  • sperm count

  • sperm motility (total motile sperm per ejaculate)

  • sperm morphology

  • sperm membrane integrity (as assessed by hypo-osmolar swelling test)

  • +5 more secondary outcomes

Interventions

Menevit anti-oxidantDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Repromed

Adelaide, South Australia, 5065, Australia

Location

Related Publications (7)

  • Aitken RJ, Baker MA. Oxidative stress and male reproductive biology. Reprod Fertil Dev. 2004;16(5):581-8. doi: 10.10371/RD03089.

    PMID: 15367373BACKGROUND

  • 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.

    PMID: 9780307BACKGROUND

  • 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.

    PMID: 12721180BACKGROUND

  • 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.

    PMID: 15066449BACKGROUND

  • 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.

    PMID: 12647778BACKGROUND

  • 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.

    PMID: 15169573BACKGROUND

  • 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.

    PMID: 9675617BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Kelton P Tremellen, MB BS (Hons) PhD

    Repromed, University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 27, 2004

First Posted

December 28, 2004

Study Start

December 1, 2004

Study Completion

March 1, 2006

Last Updated

May 3, 2006

Record last verified: 2005-06

Locations

AU(1)