3D transvaginal ultrasound and gel infusion sonography compared with MRI to find a uterine septum
Official title: SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum
Run by University Hospital, Ghent · NCT07263984 · Data updated 2026-11-12
This study will see if 3D transvaginal ultrasound and gel infusion sonography can detect a uterine septum as accurately as MRI in women aged 18–45 who are suspected to have one.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 145 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT07263984 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–45 with a suspected uterine septum on routine 2D transvaginal ultrasound who can undergo transvaginal scans and MRI and who consent to participate.
✕Probably not a fit
Patients who cannot have MRI, cannot tolerate or undergo transvaginal ultrasound, are pregnant, have had prior definitive diagnosis or surgery for a septum, or have certain congenital vaginal/cervical aplasias are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Women aged 18–45 with suspicion of a uterine septum on routine 2D TVUS will be enrolled and receive 3D transvaginal ultrasound (3D TVUS), 3D gel infusion sonography (3D GIS), and pelvic MRI, and will complete brief questionnaires. Imaging results from the ultrasound techniques will be compared with MRI findings to measure how often each method identifies a uterine septum and how well the methods agree. The protocol focuses on diagnostic performance and patient-reported tolerability of the procedures. Findings will inform whether ultrasound-based approaches can serve as a reliable, more accessible alternative to MRI for this diagnosis.
Why it matters
Potential benefit: If successful, the ultrasound techniques could provide a faster, cheaper, and more accessible way to diagnose a uterine septum and reduce reliance on MRI.
How similar studies have gone: Prior studies have shown that 3D TVUS and gel infusion sonography can have good diagnostic accuracy for uterine anomalies, but direct head-to-head comparisons with MRI remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ghent University Hospital
Ghent, Belgium Recruiting
Study contacts
- Study coordinator: Laura D'hoore, MD
- Email: septum@uzgent.be
- Phone: 0032 9 332 07 58
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing two surgical methods for removing uterine septum
This study is testing two different surgical methods for removing a uterine septum to see which one works better and has fewer complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.