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.

ConditionUterine 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Magnetic Resonance Imaging
Diagnostic test
MRI of the pelvis
Three-dimensional transvaginal ultrasound
Diagnostic test
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal Gel Infusion Sonography
Diagnostic test
Three-dimensional transvaginal Gel Infusion Sonography
Questionnaires
Other intervention
Questionnaires

Treatment groups

145 Participants

are divided into 1 treatment group

Group A: Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasoundExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Collaborator

Source ClinicalTrials.gov

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