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.

SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07263984

Acronym

SEPTUM-D

Enrollment

145

Registered

2025-12-04

Start date

2025-10-27

Completion date

2028-10-31

Last updated

2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Septum

Keywords

Uterine septum, Diagnosis, Three-dimensional transvaginal ultrasound, Magnetic Resonance Imaging, Gel Infusion Sonography

Brief 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.

Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

MRI of the pelvis

DIAGNOSTIC_TESTThree-dimensional transvaginal ultrasound

Three-dimensional transvaginal ultrasound

DIAGNOSTIC_TESTThree-dimensional transvaginal Gel Infusion Sonography

Three-dimensional transvaginal Gel Infusion Sonography

OTHERQuestionnaires

Questionnaires

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Masking description

Central readers of US and MRI images

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI	Within 12 weeks after inclusion

Countries

Belgium

Contacts

Primary ContactLaura D'hoore, MD

septum@uzgent.be0032 9 332 07 58

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026