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 now · Not applicable
Conditions studied: Uterine Septum
In brief
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.
Key facts
- Study ID
- NCT07263984
- Run by
- University Hospital, Ghent
- People needed
- 145
- Starts
- 2025-10-27
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-12-04
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Ghent University Hospital — Ghent, Belgium (enrolling)
Full record on ClinicalTrials.gov
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