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Hysteroscopy for Chronic Endometritis: Diagnostic Performance and Observer Variability

NCT06890754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-03-26

No results posted yet for this study

Summary

This study investigates the role of hysteroscopy in diagnosing chronic endometritis (CE), a condition linked to female infertility but difficult to diagnose due to nonspecific symptoms. While histological examination with CD138 ( Cluster of Differentiation 138 )immunohistochemistry is the gold standard, hysteroscopy remains widely used. This prospective, multicenter study included infertile women with no uterine abnormalities on ultrasound. Hysteroscopy was performed using standardized criteria, and its diagnostic performance was compared to histopathology. Intra- and inter-observer variability were also assessed through blinded video evaluations by two specialists. The study aimed to determine the reliability of hysteroscopy in diagnosing CE and its agreement among different observers.

Conditions

  • Chronic Endometritis

Interventions

DIAGNOSTIC_TEST

Diagnostic hysteroscopy

Diagnostic hysteroscopy. An IHC study of the expression of the plasma cell marker CD138 was systematically performed for all samples studied

Sponsors & Collaborators

  • Tunis University

    lead OTHER

Principal Investigators

  • Haithem Aloui · Tunis University Manar

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2022-08-01
Completion
2022-08-08

Countries

  • Tunisia

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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 NCT06890754 on ClinicalTrials.gov