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Completed

NCT Number: NCT06290518

Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713

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.

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Key information

Conditions

Infertility Unexplained Genital Diseases Infertility Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Biosearch S.A.U., Granada, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • legal age
  • Intention to achieve a pregnancy, but without achieving it;
  • Be willing to undergo in vitro fertilization treatment;
  • Be on the waiting list for the IVF cycle with an expected waiting time > 5 months.

Exclusion criteria

  • Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).
  • Genitourinary malformations;
  • Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).
  • Treatment/intervention other than the planned IVF after the start date of the intervention.
  • Antibiotic treatment at the start date of the intervention.
  • Intention to consume another probiotic supplement in the following 3 months.
  • Participation in another clinical trial.
  • Allergic/intolerant to the excipient.
  • Inability to understand the informed consent form and/or to follow the basic instructions of the trial.

Treatment and study plan

Ligilactobacillus salivarius CECT5713

Dietary Supplement

Oral administration of a capsule containing 9.5 log10 cfu of the strain.

Placebo

Dietary Supplement

Oral administration of a capsule containing maltodextrin.

Primary outcomes

  1. Successful pregnancies

    Time frame: 9 months

    Total number of pregnancies with delivery of a healthy baby

Secondary outcomes

  1. Modification of the vaginal microbiota

    Time frame: 9 months

    Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces)

  2. Vaginal immunomodulation

    Time frame: 9 months

    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)

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Collaborators

  • Hospital San Carlos, Madrid
  • Universidad Complutense de Madrid

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 4, 2024
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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