Uterine SeptumSEPTUM-DNCT07263984
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.
A study testing Magnetic Resonance Imaging, Three-dimensional transvaginal ultrasound and Three-dimensional transvaginal Gel Infusion Sonography in people with Uterine Septum, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Septum
- What is being tested?
- Magnetic Resonance Imaging, Three-dimensional transvaginal ultrasound and Three-dimensional transvaginal Gel Infusion Sonography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Oct 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 18 and 45 years
- With suspicion of a uterine septum on routine 2D TVUS
- Who are willing to give informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Laura D'hoore, MD, 0032 9 332 07 58, septum@uzgent.be
Tjalina Hamerlynck, MD, PhD
About this study
Official title: SEPTUM-D Project: Diagnosis in Patients With 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.
- Conditions
- Uterine Septum
- Being tested
- Magnetic Resonance Imaging, Three-dimensional transvaginal ultrasound, Three-dimensional transvaginal Gel Infusion Sonography, Questionnaires
- Keywords
- Uterine septum, Diagnosis, Three-dimensional transvaginal ultrasound, Magnetic Resonance Imaging, Gel Infusion Sonography
- Medical subject headings
- Septate Uterus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
MRI of the pelvis
Three-dimensional transvaginal ultrasoundDiagnostic test
Three-dimensional transvaginal ultrasound
Three-dimensional transvaginal Gel Infusion SonographyDiagnostic test
Three-dimensional transvaginal Gel Infusion Sonography
QuestionnairesOther
Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound | Experimental | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound Receives: Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Three-dimensional transvaginal ultrasound; Diagnostic Test: Three-dimensional transvaginal Gel Infusion Sonography; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of three-dimensional transvaginal ultrasound (3D TVUS) for the diagnosis of a uterine septum compared with MRI
Measured: Within 12 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start27 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine SeptumStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263984
- Sponsor's protocol ID
- ONZ-2025-0219
- Other IDs
- T002825N
- Acronym
- SEPTUM-D
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEPTUM-D Project: Diagnosis in Patients With a Uterine Septum
- ClinicalTrials.gov ID
- NCT07263984
- Acronym / sponsor ID
- SEPTUM-D / ONZ-2025-0219
- Conditions
- Uterine Septum
- Keywords
- Uterine septum, Diagnosis, Three-dimensional transvaginal ultrasound, Magnetic Resonance Imaging, Gel Infusion Sonography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Research Foundation - Flanders (Fonds Wetenschappelijk Onderzoek)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound | Experimental | Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: Three-dimensional transvaginal ultrasound, Diagnostic Test: Three-dimensional transvaginal Gel Infusion Sonography, Other: QuestionnairesPatients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged between 18 and 45 years
- With suspicion of a uterine septum on routine 2D TVUS
- Who are willing to give informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingMRI of the pelvis | Diagnostic test | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
| Three-dimensional transvaginal ultrasoundThree-dimensional transvaginal ultrasound | Diagnostic test | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
| Three-dimensional transvaginal Gel Infusion SonographyThree-dimensional transvaginal Gel Infusion Sonography | Diagnostic test | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
| QuestionnairesQuestionnaires | Other | Patients with suspicion of a uterine septum on two-dimensional transvaginal ultrasound |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Three-dimensional transvaginal ultrasound and Three-dimensional transvaginal Gel Infusion Sonography in people with Uterine Septum, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura D'hoore, MD (0032 9 332 07 58, septum@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.