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Infertility, MalePhase 3NCT00100269

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

A Phase 3 study testing Menevit anti-oxidant in people with Infertility, Male and Oxidative Stress, run by Repromed at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infertility, Male, Oxidative Stress
What is being tested?
Menevit anti-oxidant
How many people
60 participants
Where
1 siteAustralia
Study dates
Dec 2004to Mar 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Repromed

    Adelaide, South Australia, 5065

Other trials in Australia

About this study

Official title: 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.

Read the 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

Being tested
Menevit anti-oxidant
Keywords
Male infertility, sperm, pregnancy, IVF (in vitro fertilisation), oxidative stress, free radicals, DNA damage
Medical subject headings
Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menevit anti-oxidantDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Embryo quality (morphology score, progression to blastocyst rates, number of embryos available for freezing/transfer per cycle)

  2. 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)

  1. sperm DNA fragmentation

  2. sperm count

  3. sperm motility (total motile sperm per ejaculate)

  4. sperm morphology

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

  6. levels of sperm lipid peroxidation (LPO-586 assay)

  7. retrospective comparison of embryo quality between the Menevit IVF cycle and the preceding non-Menevit IVF cycle.

  8. miscarriage rate (clinical and biochemical)

  9. clinical pregnancy rates (number of fetal hearts seen on first trimester scan)

  10. adverse side effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2004 (estimated)
  2. Study startDec 2004
  3. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00100269
Sponsor's protocol ID
RCHDW002
Status last verified
Jun 2005
First submitted
27 Dec 2004
Last updated
3 May 2006
Results posted
No

Publications

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

    PubMed 15367373

  • 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.

    PubMed 9780307

  • 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.

    PubMed 12721180

  • 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.

    PubMed 15066449

  • 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.

    PubMed 12647778

  • 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.

    PubMed 15169573

  • 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.

    PubMed 9675617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Menevit anti-oxidant in people with Infertility, Male and Oxidative Stress, run by Repromed at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Embryo quality (morphology score, progression to blastocyst rates, number of embryos available for freezing/transfer per cycle). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00100269, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2006.

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