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NCT05612620
Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss
Conditions: Microbiome, Recurrent Pregnancy Loss
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Enrollment: 40
Sponsor: Assuta Ashdod Hospital
Location: Israel
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.
Eligibility Criteria
Inclusion Criteria:• women aged 18-40 years old, with two or more consecutive miscarriages.Exclusion Criteria:• 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.
Source: ClinicalTrials.gov (NCT05612620). StuddyBuddy aggregates publicly available trial information.