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New study aims to improve diagnosis of uterine septum with advanced ultrasound

NCT ID NCT07263984

Diagnosis Sponsor: University Hospital, Ghent Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing how well two types of 3D ultrasound can detect a uterine septum (a wall inside the uterus) compared to MRI. About 145 women aged 18-45 with a suspected septum will get both an MRI and the ultrasound exams. The goal is to see if the ultrasounds are as good as MRI, which could make diagnosis easier and less expensive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to more accurate and less invasive diagnosis of uterine septum, potentially reducing the need for MRI.
What could go wrong
This is an early diagnostic study with only 145 participants, so results may not apply to all women. The tests may not be accurate enough to replace current methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 145 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease septate uterus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Uterine septum

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ghent University Hospital

    RECRUITING

    Ghent, 9000, Belgium

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