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)

Ghent University Hospital (UZ)

Status: Enrolling

Conditions: Uterine Septum

Treatments: Other: Questionnaires; Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Three-dimensional transvaginal Gel Infusion Sonography; Diagnostic Test: Three-dimensional transvaginal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07263984

ONZ-2025-0219

T002825N (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 145 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged between 18 and 45 years
• With suspicion of a uterine septum on routine 2D TVUS
• Who are willing to give informed consent

Exclusion criteria

• Women aged below 18 years and over 45 years
• Prior definitive diagnosis of a uterine septum or other congenital uterine anomaly
• Prior surgery in relation to a uterine septum
• Cervical (unilateral) aplasia
• Vaginal aplasia
• Untreated obstructive vaginal septum
• Any co-morbidity that is found to interfere with the uterine measurements required in the study
• Contraindications for MRI
• Not willing or not possible to undergo transvaginal ultrasound
• Pregnancy at the time of inclusion
• Wish to conceive between inclusion and last diagnostic intervention
• Visual or pathological evidence of cervical, uterine or ovarian malignancy
• Patients with an intrauterine device (by mistake), who are not willing to remove this device before the start of the diagnostic interventions

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound

Experimental group

Description:

Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound

Treatment:

Diagnostic Test: Three-dimensional transvaginal ultrasound

Diagnostic Test: Three-dimensional transvaginal Gel Infusion Sonography

Diagnostic Test: Magnetic Resonance Imaging

Other: Questionnaires