3D transvaginal ultrasound and gel infusion sonography compared with MRI to find a uterine septum
SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum
NA · University Hospital, Ghent · NCT07263984
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent (other) |
| Locations | 1 site (Ghent) |
| Trial ID | NCT07263984 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ghent
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
Study contacts
- Study coordinator: Laura D'hoore, MD
- Email: septum@uzgent.be
- Phone: 0032 9 332 07 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Uterine Septum, Uterine septum, Diagnosis, Three-dimensional transvaginal ultrasound, Magnetic Resonance Imaging, Gel Infusion Sonography