Unexplained Recurrent Pregnancy Loss: New Therapeutic Perspectives

Not Applicable

Active, not recruiting

• Conditions: Miscarriage, Recurrent

• Registration Number: NCT06867900
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Evaluation of gut permeability and endometrial inflammasome NLRP3 in women with unexplaid recurrent pregnancy loss before-after administration of Bifidobacteriumlongum ES1.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-07-05
• Study First Submitted: 2023-07-06
• Status Verified: 2024-09
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Completion: 2025-07-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Idiopathic recurrent pregnancy loss
• Genetic predisposition to celiac disease

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assessment of Endometrial inflammation in RPL women	3 months	Analysis of the inflammasome NALP3 expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.
Assessment of Gut permeability status in RPL women	3 months	Analysis of zonulin expression and activation in serum and endometrial fluid in women with unexplained recurrent pregnancy loss compared to women with uncomplicated pregnancy history.

Trial Locations

Locations (1)

Reasearch Laboratory 3J IRCCS Gemelli; 🇮🇹 Rome, Italy