Hysteroscopy for Chronic Endometritis: Diagnostic Performance and Observer Variability

NCT ID: NCT06890754

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-06
• Study Completion Date: 2022-08-08

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.

Detailed Description

This study evaluates the diagnostic performance of hysteroscopy in detecting chronic endometritis (CE), a condition associated with female infertility. CE is characterized by persistent endometrial inflammation and is challenging to diagnose due to its nonspecific clinical presentation. Histopathological examination with CD138 immunohistochemistry (IHC) is currently the gold standard for CE diagnosis, yet hysteroscopy remains a commonly used tool in clinical practice.

This prospective, multicenter study was conducted between June 6, 2021, and August 8, 2022, and included infertile women aged 18 to 42 years. Participants were selected based on normal pelvic ultrasound findings, while patients with biological inflammatory syndrome, recent acute genital infections, autolysed biopsies, unusable hysteroscopy videos, atypical hyperplasia, or endometrial cancer were excluded. The final cohort comprised 70 patients.

Hysteroscopy was performed during the late follicular phase (days 8-12) using a 2.9 mm 30° rigid hysteroscope with saline distension. The procedure was conducted using a "no-touch" technique to minimize endometrial trauma and ensure accurate video interpretation. Endometrial biopsies were obtained using a Novak curette for subsequent CD138 IHC analysis.

The hysteroscopic diagnosis of CE was based on standardized criteria proposed by Cicinelli et al., including micro polyps, focal and diffuse hyperaemia, stromal oedema, strawberry aspect, and haemorrhagic spots. Recorded hysteroscopic videos were independently reviewed by two reproductive medicine specialists. To assess intra- and inter-observer variability, a second blinded evaluation was conducted four weeks later by the same observers.

The study aimed to assess the sensitivity, specificity, and predictive values of hysteroscopy in diagnosing CE while evaluating the consistency of observer interpretations. By comparing hysteroscopic findings to histopathological results, the study provides insights into the reliability of hysteroscopy as a diagnostic tool for CE and highlights its limitations due to observer variability.

Conditions

Chronic Endometritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Diagnostic hysteroscopy

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tunis University

OTHER

Sponsor Role: lead

Responsible Party

Haithem Aloui

university hospital assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haithem Aloui

Role: PRINCIPAL_INVESTIGATOR

Tunis University Manar

Locations

Haithem Aloui

Manouba, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

Endometrite hysteroscopy

Identifier Type: -

Identifier Source: org_study_id