Skip to main content
OpenTrials
Completed

NCT Number: NCT05505656

Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

This study will compare the accuracy of diagnosing adenomyosis by obtaining hysteroscopic guided endomyometrial biopsy and comparing it to accuracy of diagnosis by transvaginal ultrasound and magnetic resonance imaging.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

About this study

Preoperative diagnosis of adenomyosis is usually difficult. The use of ultrasound and MRI for preoperative diagnosis is still of low positive predictive values. The majority of cases of adenomyosis are diagnosed postoperatively after justo pathological examination of the hysterectomy specimens.

The introduction of the concept of preoperative diagnosis of adenomyosis through a hysteroscopic endomyometrial biopsies may be a very good method for preoperative diagnosis of this condition. Participants patients who are diagnosed as adenomyosis by Ultrasound and MRI and scheduled for hysterectomy will undergo an endomyometrial biopsy. The accuracy of this method, its sensitivity, specificity, positive and negative predictive values of this method will be compared with the conventional methods for preoperative diagnosis of adenomyosis after final diagnosis by final gusto pathological diagnosis of hysterectomy specimens.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with abnormal uterine bleeding due to adenomyosis diagnosed by transvaginal ultrasound and mri and scheduled for hysterectomy

Exclusion criteria

  • hysterectomy not performed
  • incomplete ultrasound and mri information

Treatment and study plan

hysteroscopic guided endomyometrial biopsy

Diagnostic Test

we will obtain hysteroscopic guided endomyometrial biopsy in cases of adenomyosis

Primary outcomes

  1. To compare endomyometrial biopsy with postoperative pathology to calculate Accuracy and likelihood ratio of endomyometrial biopsy to diagnose adenomyosis .

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Sensitivity, specificity, positive and negative predictive values of endomyometrial biopsy for diagnosis of adenomyosis compared to US and MRI

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis. A Prospective Cross-sectional Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2022
Registry last updated
Oct 10, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.