RecruitingNot Applicable

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.

Belgium145 participantsStarted 2025-10-27

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI

Timeframe: Within 12 weeks after inclusion

Trial details

NCT IDNCT07263984

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-10

Contact for this trial

Laura D'hoore, MD

0032 9 332 07 58 septum@uzgent.be

View on ClinicalTrials.gov More Uterine Septum trials