Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
NCT07263984

Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.

Led by University Hospital, Ghent · Updated on 2025-12-04

145

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

R

Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to investigate the added value of three-dimensional transvaginal ultrasound (3D TVUS) and gel infusion sonography (3D GIS) for diagnosing a partition in the uterus (uterine septum) in comparison to magnetic resonance imaging (MRI). The main question it aims to answer is: How well do 3D TVUS and 3D GIS detect a uterine septum compared to MRI? Participants will receive 3D TVUS/ 3D GIS and MRI, and will complete questionnaires.

CONDITIONS

Official Title

Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.

Who Can Participate

Age: 18Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged between 18 and 45 years
  • Suspicion of a uterine septum on routine 2D transvaginal ultrasound
  • Willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Women younger than 18 years or older than 45 years
  • Prior definitive diagnosis of a uterine septum or other congenital uterine anomaly
  • Previous surgery related to a uterine septum
  • Cervical (unilateral) aplasia
  • Vaginal aplasia
  • Untreated obstructive vaginal septum
  • Any health condition interfering with required uterine measurements
  • Contraindications for MRI
  • Unable or unwilling to undergo transvaginal ultrasound
  • Pregnant at the time of inclusion
  • Planning to conceive between inclusion and last diagnostic intervention
  • Visual or pathological evidence of cervical, uterine, or ovarian cancer
  • Presence of an intrauterine device and unwillingness to remove it before diagnostics

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

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Research Team

L

Laura D'hoore, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum. | DecenTrialz