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Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin

NCT04446572 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-06-26

No results posted yet for this study

Summary

In this study, we aimed to assess the cervicovaginal environment (pH, Nugent score, soluble immune factors and bacterial profile) in women with reproductive failure because of either repetitive abortion or infertility of unknown origin and compare it to that of healthy fertile women. The second objective was to evaluate the ability of Lactobacillus salivarius CECT5713 to modulate such parameters and to increase pregnancy rates in women with reproductive failure. The administration of L. salivarius CECT5713 (\~9 log10 colony-forming units (CFU)/day) for 6 months or until a diagnosis of pregnancy to women with reproductive failure resulted in an overall successful (term) pregnancy rate of 56%.

Conditions

  • Abortion, Spontaneous
  • Abortion in First Trimester
  • Infertility Unexplained

Interventions

BIOLOGICAL

Lactobacillus salivarius CECT5713

Starting at day 0, women of the RA and INF groups consumed (oral route) a daily sachet with \~50 mg of freeze-dried probiotic (\~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).

Sponsors & Collaborators

  • Bisearch Life

    collaborator UNKNOWN

  • Centro de Diagnóstico Médico. Ayuntamiento de Madrid.

    collaborator UNKNOWN

  • Universidad Complutense de Madrid

    lead OTHER

Principal Investigators

  • Juan M Rodríguez, PhD · Complutense University Madrid

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
33 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-11-29
Completion
2019-11-29

Countries

  • 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 NCT04446572 on ClinicalTrials.gov