Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss

NCT05612620 | Unknown

• 1 other identifier: 0140-21-AAA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Microbiome differences in patients with repeat pregnancy loss and healthy population

  microbiome data will be analyzed using standard methods for rarefaction, alpha and beta diversity and abundance of taxa at different taxonomical levels. A statistical analysis will be performed in order to evaluate if there is a significant difference in the presence of different bacteria strains in patients with a history of RPL and healthy controls

  through study completion, an average of 2 years

Study Arms (2)

RPL

Samples from the vagina, fornix and cervical canal and rectum 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.

Diagnostic Test: coulture

Healthy

Samples from the vagina, fornix and cervical canal and rectum 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.

Diagnostic Test: coulture

Interventions

coulture DIAGNOSTIC_TEST

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.

Healthy; RPL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with two or more consecutive miscarriages ages 18-40 With a normal uterine cavity as per hysteroscopy, no chromosomal abnormalities and negative APLA test.

You may qualify if:

• women aged 18-40 years old, with two or more consecutive miscarriages.

You may not qualify if:

• documented past PID,
• previous history of uterine malformations,
• patients with hyperplasia and endometrial cancer,
• patients with IUD and antimicrobial treatment in the preceding 4 weeks.

Sponsors & Collaborators

• Assuta Ashdod Hospital: lead

Study Sites (1)

Assuta Ashdod University Hospital

Ashdod, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples from uterine discharge vaginal discharge and stool samples

Study Officials

• Oshri Barel, MD

  Assuta Ashdod Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 10, 2022
• Study Start: November 14, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-09

Locations

IL (1)