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Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss

NCT05612620 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-11-10

No results posted yet for this study

Summary

Recurrent pregnancy loss (RPL) is defined as 2 or more consecutive miscarriages1 This condition affects about 1-3% of couples during their reproductive years. The role of vaginal infections in RPL is controversial and microbiological screening is not recommended as per the international guidelines. Current theories suggest that altered vaginal and uterine microbiota may trigger an inflammatory response in the endometrium even without the presence of clinical infection which could affect the success of embryo implantation and future development of pregnancy2 .Changes in the uterine microbiota can lead to chronic endometritis (CE). This condition is caused by continuing inflammation of the endometrium, involving a variety of common bacterial and yeast species and has been associated with RPL3 . Notably, CE can be found in up to 45% of infertile patients4. Current diagnosis of CE is based on histopathological examination, immunohistochemistry assay for CD138 cells and morphological appearance on hysteroscopy. While antibiotic treatment can improve ongoing pregnancy rates in patients with RPL treatment success is still partial and unpredictable. A mechanistic link is yet to be established between vaginal and uterine microbiota and RPL and it is unknown whether restoration of the microbiome in patients with RPL can improve pregnancy outcomes.

Conditions

  • Microbiome
  • Recurrent Pregnancy Loss

Interventions

DIAGNOSTIC_TEST

coulture

Samples from the vagina, fornix and cervical canal will be taken by introducing a flocked nylon swab to the vagina via a speculum and circular swabbing for 5-10 seconds before using any antiseptics.

Sponsors & Collaborators

  • Assuta Ashdod Hospital

    lead OTHER

Principal Investigators

  • Oshri Barel, MD · Assuta Ashdod Hospital

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Israel

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 NCT05612620 on ClinicalTrials.gov