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Hysteroscopy for Chronic Endometritis: Diagnostic Performance and Observer Variability

Performance of Hysteroscopy in Diagnosing Chronic Endometritis and the Role of Intra- and Inter-Observer Variability: A Prospective Study of 70 Cases.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06890754
Enrollment
70
Registered
2025-03-24
Start date
2021-06-06
Completion date
2022-08-08
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Endometritis

Keywords

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

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.

Interventions

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

Sponsors

Tunis University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Participants Undergoing Diagnostic HysteroscopyperoperativelyExamination of the uterine cavity and the cervico-isthmic canal.
Expression of CD138 Marker in Endometrial BiopsyFirst 24 hoursAn 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.

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026