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CompletedNCT02300805VOCALUpdated Jan 12, 2016

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

An observational study in Premenopausal; Metrorrhagia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-01-12.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
117
Ages
20 Years to 50 Years
Sex
Female
01

Study 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 .

02

Conditions studied

  • Premenopausal; Metrorrhagia

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Keywords

  • Endometrial volume , VOCAL , Endometrial , Metrorrhagia
03

In context

Metrorrhagia

95 studies on the registry are indexed under Metrorrhagia; 24 are open to participants now.

This study's enrollment of 117 is below the median of 202 across 19 observational studies indexed under Metrorrhagia.

Browse Metrorrhagia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Premenopausal women complaining of irregular vaginal bleeding

Inclusion criteria

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

Exclusion criteria

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 ) .
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
117 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: One year

07

Study locations

1 site
  • Ain Shams Maternity Hospital
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02300805
Lead sponsor
Ain Shams University
Responsible party
dr mohamed laban (professor mohammed laban, Ain Shams University) — Principal investigator
First posted
Nov 25, 2014
Start date
Nov 2014
Primary completion
Nov 2015
Completion
Dec 2015
Last update
Jan 12, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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