Accuracy of Endometrial Volume Measured by VOCAL Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Completed

• Conditions: Premenopausal; Metrorrhagia

• Registration Number: NCT02300805
• Lead Sponsor: Ain Shams University

Brief Summary

Endometrial volume will be assessed by 3DUS and VOCAL and compared to the results of office hysterscopy to measure the abilty of this technique to diagnose endometrial polyps in women complaining of abnormal uterine bleeding.

The safety of both procedures will be compared .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-09
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 117

Inclusion Criteria

• Age more than 20 years
• Patients with irregular vaginal bleeding

Exclusion Criteria

• Age less than 20 years
• Postmenopausal women
• presence of uterine fibroids
• Causes of vaginal bleeding due to systemic pathology , anticoagulant use , patients on hormonal contraception or using Intra Uterine Contraceptive Device ( IUCD ) .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the Safety and Tolerability" and "Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women	one year	A prospective Observational Study

Secondary Outcome Measures

Name	Time	Method
To measure the best cut off value for endometrial volume (CC ) using Three Dimensional Sonography ( 3DUS and (VOCAL ) to diagnose endometrial polyps in women with premenopausal bleeding	One year

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt