NCT05505656

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

August 14, 2022

Last Update Submit

October 8, 2024

Conditions

Adenomyosis

Outcome Measures

Primary Outcomes (1)

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

    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

    through study completion, an average of 1 year

Interventions

hysteroscopic guided endomyometrial biopsyDIAGNOSTIC_TEST

we will obtain hysteroscopic guided endomyometrial biopsy in cases of adenomyosis

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients with abnormal uterine bleeding as diagnosed by ultrasound and mri

You may qualify if:

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

You may not qualify if:

  • hysterectomy not performed
  • incomplete ultrasound and mri information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Mohamed Laban

    Professor of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 18, 2022

Study Start

June 9, 2022

Primary Completion

July 9, 2024

Study Completion

July 9, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations

EG(1)