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

Premenopausal; Metrorrhagia Clinical Trial

— VOCAL  

Official title:

Accuracy of Endometrial Volume Measured by Virtual Organ Computer-aided AnaLysis (VOCAL)Versus Office Hysteroscopy for Diagnosis of Endometrial Polyps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300805
• Other study ID #: lab7681
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: January 9, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metrorrhagia
• Premenopausal; Metrorrhagia

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the Safety and Tolerability" and "Efficacy of 3DUS versus office Hysteroscopy for diagnosis of endometrial polyps in premenopausal women	A prospective Observational Study	one year	Yes
Secondary	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	No