An interventional study of Ligilactobacillus salivarius CECT5713 and Placebo in Infertility Unexplained, sponsored by Biosearch S.A.. Completed at 3 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by Biosearch S.A. · Not applicable, Interventional, and Basic science
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 72 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Biosearch S.A. is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin) 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.
Dietary Supplement: Ligilactobacillus salivarius CECT5713
All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin 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.
Dietary Supplement: Placebo
Oral administration of a capsule containing 9.5 log10 cfu of the strain.
Oral administration of a capsule containing maltodextrin.
Successful pregnancies
Total number of pregnancies with delivery of a healthy baby
Time frame: 9 months
Modification of the vaginal microbiota
Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces)
Time frame: 9 months
Vaginal immunomodulation
Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, RANTES, TGF-β1, 2 and 3, VEGF, GRO-alpha and TNF-alpha)
Time frame: 9 months
Plan to share: Yes — Global and individual reproductive rates, microbiological and immunological data will be available to other researchers once the study (including analyses of all the samples) is completed and published.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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