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.
NCT ID: NCT07263984
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
145 participants
INTERVENTIONAL
2025-10-27
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound
Magnetic Resonance Imaging
MRI of the pelvis
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal Gel Infusion Sonography
Three-dimensional transvaginal Gel Infusion Sonography
Questionnaires
Questionnaires
Interventions
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Magnetic Resonance Imaging
MRI of the pelvis
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal Gel Infusion Sonography
Three-dimensional transvaginal Gel Infusion Sonography
Questionnaires
Questionnaires
Eligibility Criteria
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Inclusion Criteria
* With suspicion of a uterine septum on routine 2D TVUS
* Who are willing to give informed consent
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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Ghent University Hospital
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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T002825N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ONZ-2025-0219
Identifier Type: -
Identifier Source: org_study_id
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