NCT06290518

Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility Unexplained

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ligilactobacillus salivarius CECT5713	Oral administration of a capsule containing 9.5 log10 cfu of the strain.
DIETARY_SUPPLEMENT	Placebo	Oral administration of a capsule containing maltodextrin.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-03
• Completion: 2024-01-29
• First posted: 2024-03-04
• Last updated: 2024-03-04

Locations

3 sites across 1 country: Spain