Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ghent University Hospital
Ghent, Belgium, 9000
Actively Recruiting
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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