Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100269
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2004-12-27
Brief Title:
Menevit Study Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Sponsor:
Repromed
Organization:
Repromed
Study Overview
Official Title:
A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 21 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 Menevitplacebo 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None