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NCT Number: NCT07263984

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.

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.

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Key information

Conditions

Uterine Septum Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases, Female Pathologic Processes Pathological Conditions, Signs and Symptoms Septate Uterus Urogenital Diseases Uterine Diseases Uterine Duplication Anomalies

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Laura D'hoore, MD

CONTACT

[email protected]

0032 9 332 07 58

Tjalina Hamerlynck, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

MRI of the pelvis

Three-dimensional transvaginal ultrasound

Diagnostic Test

Three-dimensional transvaginal ultrasound

Three-dimensional transvaginal Gel Infusion Sonography

Diagnostic Test

Three-dimensional transvaginal Gel Infusion Sonography

questionnaires

Other

Questionnaires

Primary outcomes

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

    Time frame: Within 12 weeks after inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Laura D'hoore, MD

CONTACT

[email protected]

0032 9 332 07 58

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)

Registry information

Official study title

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

Acronym: SEPTUM-D

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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