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

Study Overview
=================
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

Official Title
-----------------
A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Conditions
-----------------
Infertility, Male, Oxidative Stress

Intervention / Treatment
-----------------
* Drug: Menevit anti-oxidant


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Menevit anti-oxidant|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male infertility, sperm, pregnancy, IVF (in vitro fertilisation), oxidative stress, free radicals, DNA damage