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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging, Three-dimensional transvaginal ultrasound, Three-dimensional transvaginal Gel Infusion Sonography, Questionnaires.
- Who it may be relevant to
- Registry conditions: Uterine Septum. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum
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.
Interventions
- 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 - Other Questionnaires
Questionnaires
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Ghent University Hospital — Ghent
Identifiers
NCT: NCT07263984 · ONZ-2025-0219 · T002825N