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.
NCT07263984 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2025-12-04
Summary
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
- Uterine Septum
Interventions
- DIAGNOSTIC_TEST
-
Magnetic Resonance Imaging
MRI of the pelvis
- DIAGNOSTIC_TEST
-
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal ultrasound
- DIAGNOSTIC_TEST
-
Three-dimensional transvaginal Gel Infusion Sonography
Three-dimensional transvaginal Gel Infusion Sonography
- OTHER
-
Questionnaires
Questionnaires
Sponsors & Collaborators
-
Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
collaborator OTHER -
University Hospital, Ghent
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-27
- Primary Completion
- 2028-10-31
- Completion
- 2028-10-31
Countries
- Belgium
Study Locations
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