Histopathological Diagnosis of Adenomyosis

Adenomyosis Clinical Trial

Official title:

The Diagnostic Accuracy of Hysteroscopic Endomyometrial Biopsy in Adenomyosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340533
• Other study ID #: AD0152015
• Status: Completed
• Phase: N/A
• First received: January 9, 2015
• Last updated: July 26, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and evaluate a hysteroscopic endo-myometrial biopsy for diagnosing adenomyosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 38 Years to 52 Years

Eligibility

Inclusion Criteria:

• females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia

Exclusion Criteria:

• refusal of the patient to get enrolled in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Procedure:
• hysteroscopic endo-myometrial biopsy

Device:
• ultrasound
two dimensional trans-vaginal ultrasonography

Locations

Country	Name	City	State
Egypt	Kasr el aini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with diagnosis of adenomyosis cases		6 months	No