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FERTIBIOME® | Clinical Evidence: Couples Undergoing ART

9 Mar 2025

Ligilactobacillus salivarius PS11610 exerts an effect on the microbial and immunological profiles of couples with unexplained infertility.

Study Details

Study conducted in 2020 by the La Paz University Hospital, Madrid (Spain). Published in the American Journal of Reproductive Immunology, 2022. Registered at Clinicaltrials.gov.

Abstract

Problem

Unknown or idiopathic infertility has been associated with urogenital tract dysbiosis, reducing pregnancy and delivery rates during assisted reproductive treatments (ART). The Ligilactobacillus salivarius PS11610 strain has shown extraordinary antimicrobial activity in vitro against urogenital pathogens as well as other probiotic characteristics. Therefore, an intervention study was performed to evaluate the effect of L. salivarius PS11610 on the microbial composition of the urogenital tract in infertile couples with bacterial dysbiosis.

Method of Study

Seventeen couples undergoing ART, diagnosed with unknown infertility, were selected. After confirming urogenital dysbiosis, they started a 6-month treatment with L. salivarius PS11610 (1 dose/12 h for female and 1 dose/24 h for male). Vaginal, seminal, glans, uterine, and plasma samples were collected for determination of the microbiome and immune profile at the beginning and the end of the treatment.

Results

Supplementation with L. salivarius PS11610 significantly modified the urogenital microbiome composition in male and female samples, solving dysbiosis in 67% of the couples. Pathogens disappeared from the vaginal samples, whereas Lactobacilli percentage increased after 3 and 6 months of treatment. Moreover, L. salivarius PS11610 changed the uterine microbiome, which could be associated with a change in the uterine immune profile. Additionally, the probiotic intake could be associated with the observed change in the systemic immunological profile of couples. Finally, the pregnancy and delivery rates were improved.

Conclusions

Probiotic supplementation with L. salivarius PS11610 improved the male and female urogenital tract microbiome, modulating the immune system and increasing pregnancy success in couples undergoing ART.

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