Diagnosis of patients with a uterine septum Urological and Genital Diseases
Conditions
Interventions
Three-dimensional transvaginal ultrasound (3D TVUS) and three-dimensional gel infusion sonography (3D GIS).
Comparison: Magnetic resonance imaging (MRI) of the pelvis.
Trial flow:
1. Suspicion of a
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 18 and 45 years 2. With suspicion of a uterine septum on routine 2D TVUS 3. Who are willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Women aged below 18 years and over 45 years 2. Prior definitive diagnosis of a uterine septum or other congenital uterine anomaly 3. Prior surgery in relation to a uterine septum 4. Cervical (unilateral) aplasia 5. Vaginal aplasia 6. Untreated obstructive vaginal septum 7. Any co-morbidity that is found to interfere with the uterine measurements required in the study 8. Contraindications for MRI 9. Not willing or not possible to undergo a transvaginal ultrasound 10. Pregnancy at the time of inclusion 11. Wish to conceive between inclusion and the last diagnostic intervention 12. Visual or pathological evidence of cervical, uterine or ovarian malignancy 13. Patients with an intrauterine device (by mistake), who are not willing to remove this device before the start of the diagnostic interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity of 3D TVUS for the diagnosis of a uterine septum compared with MRI by uterine measurements conforming to the ESHRE/ESGE, CUME, ASRM classification at 1 timepoint (when the 3D TVUS and MRI are performed) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The specificity of 3D TVUS for the diagnosis of a uterine septum compared with MRI by uterine measurements conforming to the ESHRE/ESGE, CUME, ASRM classification at 1 timepoint (when the 3D TVUS and MRI are performed) 2. The sensitivity and specificity of 3D GIS for the diagnosis of a uterine septum compared with MRI by uterine measurements conforming to the ESHRE/ESGE, CUME, ASRM classification at 1 timepoint (when the 3D TVUS and MRI are performed) 3. The interrater reproducibility of 3D TVUS and 3D GIS for the diagnosis of a uterine septum by uterine measurements conforming to the ESHRE/ESGE, CUME, ASRM classification at 1 timepoint (after the 3D TVUS/3D GIS and MRI are performed) by a second reader. 4. Patient experience of 3D TVUS, 3D GIS and MRI with questionnaires using the validated survey instrument Testing Morbidities Index for 3D TVUS, 3D GIS and MRI, 1 week after each test was performed. 5. Cost-effectiveness of 3D TVUS and 3D GIS for the diagnosis of a uterine septum compared with MRI using the EQ-5D-5L and iPCQ questionnaires after inclusion and after final diagnosis. | — |
Countries
Belgium
Contacts
Public ContactStudy nurses Women’s Clinic GYNOBS Study nurses Women’s Clinic GYNOBS
Outcome results
None listed