Haithem Aloui
Manouba, Tunis Governorate, 2010, Tunisia
NCT Number: NCT06890754
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.
Looking for future studies?
Notify Me18 year–42 year
Female
Observational
Manouba, Tunis Governorate, 2010, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diagnostic hysteroscopy. An IHC study of the expression of the plasma cell marker CD138 was systematically performed for all samples studied
Time frame: peroperatively
Examination of the uterine cavity and the cervico-isthmic canal.
Time frame: First 24 hours
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.
Tunis University
Other
Performance of Hysteroscopy in Diagnosing Chronic Endometritis and the Role of Intra- and Inter-Observer Variability: A Prospective Study of 70 Cases.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02648698
Chronic Endometritis
Beijing, Beijing Municipality, China
View Trial DetailsNCT04432467
Adnexal Diseases, Chronic Endometritis
Minsk, Belarus
View Trial DetailsNCT02646930
Abortion, Spontaneous, Chronic Endometritis
Chicago, Illinois, United States
View Trial DetailsNCT04447625
Chronic Endometritis, Genital Diseases
Athens, Holargos, Greece
View Trial Details