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Hysteroscopy and CD138+ Plasma Cell Density in Chronic Endometritis

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this observational study is to learn if a hysteroscopy exam alone can find chronic endometritis, a long-lasting inflammation of the lining of the uterus. A hysteroscopy is an exam that looks inside the uterus with a thin camera. Chronic endometritis is usually confirmed with a lab test that counts CD138-positive cells, a type of immune cell, in a small tissue sample from the uterus. About 100 women will take part. All are already having a hysteroscopy and a tissue sample as part of their fertility care, often after repeated failed embryo transfers or repeated miscarriage. The main question it aims to answer is: Do the visual signs seen during hysteroscopy relate closely enough to the CD138 cell count to reliably find chronic endometritis without a lab test? Participants will: Have a hysteroscopy exam and a tissue sample from the uterus, both already part of their routine fertility care Have their hysteroscopy video reviewed by two doctors who do not know the tissue sample results Have their tissue sample checked in the lab for CD138 cells
Trial Details
NCT Number NCT07733713
Lead Sponsor Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)
Conditions
(from sponsor)
Chronic Endometritis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov