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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.

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.

Recruiting
18-45 years
Female
Phase N/A

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Overview

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.

Eligibility

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 details
    Uterine Septum

NCT07263984

University Hospital, Ghent

31 January 2026

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