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

NCT06122207 | Recruiting

• 1 other identifier: FEC/23.03
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.

  The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.

  After 3 months of intervention.

• Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.

  The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.

  After 6 months of intervention.

Secondary Outcomes (18)

• Number of vaginal dysbiosis criteria in case of pregnancy confirmation.

  Up to 6 months.

• Percentage (%) of women with vaginal dysbiosis.

  Before intervention.

• Number of dysbiosis criteria per woman.

  Before intervention.

• Number of dysbiosis criteria per woman.

  After 3 months of treatment pregnancy confirmation.

• Number of dysbiosis criteria per woman.

  After 6 months of treatment or pregnancy confirmation.

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Women will take two daily doses containing approximately 2\*10E9 Colony Forming Unit (CFU) of Ligilactobacillus salivarius PS11610 (Fertibiome®). Men will take one daily dose containing approximately 1\*10E9 CFU of Ligilactobacillus salivarius PS11610 (Fertibiome®). In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Women will take two daily doses of Placebo supplement. Men will take one daily dose of Placebo supplement. In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

* 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.

Placebo

Probiotic DIETARY_SUPPLEMENT

* 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.

Probiotic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples or women with ages between 18 and 45 for woman and between 18 and 55 for man (in case of couple participation).
• Couples or women with fertility disorders.
• Couples or women undergoing IVF treatment or willing to start it.
• Signature of the Informed Consent.

You may not qualify if:

• Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.
• Women with Body Mass Index (BMI) ≥ 30.
• Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:
• Azoospermia
• Sperm motility (A + B) \< 25%.
• Sperm morphology ≤ 2%.
• Vas deferens obstruction.
• Couples or women with any of the following characteristics:
• Chronic diseases that cause intestinal malabsortion.
• Congenital or acquired immunodeficiency.
• Current history or diagnosis of alcohol, tobacco, or drug abuse.
• Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.
• Under treatment with probiotics during the last week.

Sponsors & Collaborators

• ProbiSearch SL: lead

Study Sites (2)

Dr. Miguel Raimundo (Portugal)

Lisbon, Portugal

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Susana Manzano Jiménez, PhD

CONTACT

918035179; susana.manzano@probisearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 8, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

PT (1); ES (1)