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.

SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-10-27
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Belgium