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CompletedNCT02340533Updated Jul 28, 2015

Histopathological Diagnosis of Adenomyosis

An interventional study of hysteroscopic endo-myometrial biopsy and ultrasound in Adenomyosis, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 38 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-28.

Sponsored by Woman's Health University Hospital, Egypt · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
38 Years to 52 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Adenomyosis

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Keywords

  • adenomyosis
03

In context

Adenomyosis

135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 73 interventional studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
38 Years to 52 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • refusal of the patient to get enrolled in the study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    adenomyosis

    females attending the gynecology outpatient clinic complaining of chronic pelvic congestion will get enrolled in the study. Two dimensional ultrasonography will be performed to asses the presence or absence of adenomyosis or any associated lesions. All the patients were then be subjected to office hysteroscopy and endo-myometrial biopsies will be taken. Histopathological examination of the samples will then be done. From these recruited patients, some will be indicated to perform hysterectomy. The final diagnosis will then be based on the histopathological examination of the specimen retrieved from hysterectomy. The accuracy of the ultrasound and the hysteroscopic endo-myometrial biopsy will then be compared and assessed.

    Procedure: hysteroscopic endo-myometrial biopsy · Device: ultrasound

Interventions

  • Procedurehysteroscopic endo-myometrial biopsy
  • Deviceultrasound

    two dimensional trans-vaginal ultrasonography

06

What researchers measure

Primary outcomes

  1. Number of participants with diagnosis of adenomyosis cases

    Time frame: 6 months

07

Study locations

1 site
  • Kasr el aini hospital
    Cairo, 12211, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02340533
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
Dina Mohamed Refaat Dakhly (lecturer of obstetrics and gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Jan 16, 2015
Start date
Jan 2015
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 28, 2015

Study contacts

Dina M Dakhly, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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