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Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.

NCT06122207 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-13

No results posted yet for this study

Summary

In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).

Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.

An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.

The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.

Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.

Conditions

  • Fertility Disorders

Interventions

DIETARY_SUPPLEMENT

Probiotic

* Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy: * Women: 1 capsule of probiotic per day for 12 weeks. * Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months.

DIETARY_SUPPLEMENT

Placebo

* Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy: * Women:1 capsule of placebo per day for 12 weeks. * Men: 1 capsule of placebo per day for 6-months.

Sponsors & Collaborators

  • ProbiSearch SL

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06122207 on ClinicalTrials.gov