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Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Biosearch S.A.U.
Granada, Spain
Hospital Clínico San Carlos
Madrid, Spain
Universidad Complutense de Madrid
Madrid, Spain
Start Date
September 1, 2020
Primary Completion Date
May 3, 2023
Completion Date
January 29, 2024
Last Updated
March 4, 2024
72
ACTUAL participants
Ligilactobacillus salivarius CECT5713
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Biosearch S.A.
Collaborators
NCT07404969
NCT06821685
Data Source & Attribution
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