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)

December 1, 2025 updated by: University Hospital, Ghent

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Laura D'hoore, MD
  • Phone Number: 0032 9 332 07 58
  • Email: septum@uzgent.be

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University Hospital
        • Contact:
        • Principal Investigator:
          • Tjalina Hamerlynck, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Other: Questionnaires
Questionnaires
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI
Time Frame: Within 12 weeks after inclusion
Within 12 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2025-0219
  • T002825N (Other Grant/Funding Number: FWO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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