Ignite Creation Date:
2024-05-05 @ 11:44 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407432
Status:
COMPLETED
Last Update Posted:
2016-06-09
First Post:
2011-06-28
Brief Title:
Impact of Folates in the Care of the Male Infertility
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Folates in the Care of the Male Infertility
Status:
COMPLETED
Status Verified Date:
2016-05
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:
FOLFIV
Brief Summary:
Unexplained male infertility is increasing and nowadays the investigators only can propose palliative treatment as In VITRO Fertilization IVF The folate metabolism is a key for the maintenance of genome integrity A dysfunction in this pathway can be responsible of spermatogenesis defects and further of infertility Few assays have shown that folate treatment can improve sperm parameters and fertility till 30 in some of theses studies The purpose of the investigators study is to demonstrate the impact of folates treatment on improvement of sperm parameters and on the rate of success of in VITRO fertilization procedures
Detailed Description:
The folate impact in the treatment of male infertility will be reviewed by this large multicentric randomized controlled double-blind study comparing 2 parallel groups of 184 patients In each group folic acid 15mgday versus placebo orally for at least 3 months duration of a cycle of spermatogenesis This assay will evaluate the effectiveness of treatment with folic acid compared to its placebo in infertile men with the outcome of IVF-ICSI techniques pregnancy rate It will also assess the impact of folate therapy on sperm parameters and further the impact on abnormal sperm DNA methylation profiles
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