Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290518
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2024-02-08
Brief Title:
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
Sponsor:
Biosearch SA
Organization:
Biosearch SA
Study Overview
Official Title:
Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause On the other hand the project is aimed to detect microbiological immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective This is a randomized double-blind parallel-group controlled nutritional intervention study The intervention Ligilactobacillus salivarius CECT5713 or placebo will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle estimated 1-2 months In case of pregnancy the woman will continue the treatment until 12 weeks of gestation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None