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 | Recruiting

• 2 other identifiers: ONZ-2025-0219T002825N
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Uterine septum; Diagnosis; Three-dimensional transvaginal ultrasound; Magnetic Resonance Imaging; Gel Infusion Sonography

Outcome Measures

Primary Outcomes (1)

• Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI

  Within 12 weeks after inclusion

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

MRI of the pelvis

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

Three-dimensional transvaginal ultrasound DIAGNOSTIC_TEST

Three-dimensional transvaginal ultrasound

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

Three-dimensional transvaginal Gel Infusion Sonography DIAGNOSTIC_TEST

Three-dimensional transvaginal Gel Infusion Sonography

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

Questionnaires OTHER

Questionnaires

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek): collaborator

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Septate Uterus; Disease

Interventions

Magnetic Resonance Imaging; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Duplication Anomalies; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Laura D'hoore, MD

CONTACT

0032 9 332 07 58; septum@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Central readers of US and MRI images
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 4, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

BE (1)