Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

July 13, 2019 updated by: Hatem AbuHashim

A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women

Hysteroscopy has now become a gold-standard technique carried out for uterine cavity assessment in infertile women. Apart from direct visualizing of the endometrium by the naked eye, pathologies missed by other modalities of investigation can be picked up and managed appropriately. Unfortunately, the procedure itself is not free from complications e.g. perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and considered as an invasive procedure.

Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in identifying uterine cavity abnormalities due to its ability to obtain a view of three different planes of the uterus, which could be used to locate the position of intracavitary pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have 41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but its sensitivity, specificity and accuracy still a matter of debate and warrants more evaluation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Mansourah, Dakahlia Governorate, Egypt
        • Mansoura university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile women (primary or secondary) aged between 18 and 40 years.

Description

Inclusion Criteria:

  • Infertile women (primary or secondary)
  • Age between 18 and 40 years.

Exclusion Criteria:

  • age<18 years and˃ 40 years.
  • pelvic inflammatory disease.
  • .Active uterine bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Three-dimensional transvaginal ultrasonography (3D-TVS)
The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed.
Device: 3D-TVS
The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of 3D-TVS
Time Frame: At 1 week postmenstrual
The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.
At 1 week postmenstrual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hatem AbuHashim

Investigators

  • Principal Investigator: Mohamed Fekry, MSc, Faculty of Medicine, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.18.10.99

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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