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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Ghent

About this trial

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 criteria

Qualifiers

Women aged between 18 and 45 years

With suspicion of a uterine septum on routine 2D TVUS

Who are willing to give informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Magnetic Resonance Imaging
  • Three-dimensional transvaginal ultrasound
  • Three-dimensional transvaginal Gel Infusion Sonography
  • Questionnaires

Treatment groups

145 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Ghent

Lead sponsor

Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Collaborator