Hysteroscopy for Chronic Endometritis: Diagnostic Performance and Observer Variability

NCT06890754 | Completed

• 1 other identifier: Endometrite hysteroscopy
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic endometritis; intra-observer variability; inter-observer variability; hysteroscopy; CD138

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Undergoing Diagnostic Hysteroscopy

  Examination of the uterine cavity and the cervico-isthmic canal.

  peroperatively

• Expression of CD138 Marker in Endometrial Biopsy

  An immunohistochemical study of plasma cell marker CD138 expression was systematically performed on all analyzed samples. The anti-CD138 monoclonal antibody (Clone Ml15, Leica Biosystems, Reference: PA0088), ready to use on the BOND immunohistochemistry automated system, was used.

  First 24 hours

Interventions

Diagnostic hysteroscopy DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consisted of infertile women aged 18 to 42 years with no uterine abnormalities on pelvic ultrasound. Exclusion criteria included biological inflammatory syndrome, recent acute genital infections (within three months), antibiotic therapy, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, and endometrial cancer. The sample size was determined based on the reported prevalence of chronic endometritis (CE) in infertile women, ranging from 2.8% to 30%, with a calculated target of 68 participants to ensure statistical significance at a 95% confidence level.

You may qualify if:

• included women aged 18 to 42 years, consulting for infertility, with a pelvic ultrasound showing no uterine abnormalities

You may not qualify if:

• Excluded from the study were patients with biological inflammatory syndrome, those on antibiotic therapy or with a recent acute genital infection (less than three months), autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer.

Sponsors & Collaborators

• Tunis University: lead

Study Sites (1)

Haithem Aloui

Manouba, Tunis Governorate, 2010, Tunisia

Location

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Haithem Aloui

  Tunis University Manar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university hospital assistant

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: June 6, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 8, 2022
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)