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.

ISRCTN	ISRCTN21347319
DOI	https://doi.org/10.1186/ISRCTN21347319
Secondary identifying numbers	T002825N

Submission date: 16/10/2025
Registration date: 17/10/2025
Last edited: 17/10/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study will investigate the added value of three-dimensional transvaginal ultrasound (3D TVUS) and gel contrast sonohysterography (3D GIS) for diagnosing a uterine septum compared to magnetic resonance imaging (MRI). The research will allow us to optimise the diagnostic pathway for a uterine septum.

Who can participate?
Patients aged between 18 and 45 years with a suspected uterine septum based on a two-dimensional transvaginal ultrasound.

What does the study involve?
Participants will undergo two imaging techniques, 3D TVUS / 3D GIS and a standard pelvic MRI, to assess their diagnostic accuracy. Questionnaires regarding health and productivity will be completed after inclusion and after the final diagnosis. Questionnaires regarding patient experience will be completed 1 week after 3D TVUS / 3D GIS and 1 week after MRI.

What are the possible benefits and risks of participating?
Participation in this study offers the benefit of an additional diagnostic examination (transvaginal gel infusion sonography), which may improve the accuracy of the diagnosis. Your participation in the study could potentially help patients in the future.
The chance of experiencing any harm from participating in this study is extremely low. There is a very low risk of an allergic reaction or pelvic inflammation after a gel infusion sonography.

Where is the study run from?
Ghent University Hospital, Belgium.

When is the study starting and how long is it expected to run for?
January 2025 to December 2028

Who is funding the study?
Research Foundation Flanders (FWO), Belgium.

Who is the main contact?
Prof Tjalina Hamerlynck, septum@uzgent.be

Contact information

Dr Laura D'hoore
Scientific

Corneel Heymanslaan 10
Ghent
9000
Belgium

ORCID ID	0000-0003-2556-274X
Phone	+32 09 332 07 58
Email	laura.dhoore@uzgent.be

Dr Tessa Van Steenstraeten
Scientific

Corneel Heymanslaan 10
Ghent
9000
Belgium

ORCID ID	0009-0006-3768-5316
Phone	+32 09 332 07 58
Email	tessa.vansteenstraeten@uzgent.be

Prof Tjalina Hamerlynck
Principal Investigator

Corneel Heymanslaan 10
Ghent
9000
Belgium

ORCID ID	0000-0002-8290-3101
Phone	+32 09 332 07 58
Email	septum@uzgent.be

Mrs Study nurses Women’s Clinic GYNOBS Study nurses Women’s Clinic GYNOBS
Public

Corneel Heymanslaan 10
Ghent
9000
Belgium

Phone	+32 9 332 07 58
Email	gynobs.studies@uzgent.be

Study information

Study design	Prospective multicentre cohort study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	SEPTUM-D project: Diagnosis in patients with a uterine septum
Study acronym	SEPTUM-D
Study objectives	Background: Previous studies suggest that 3D transvaginal ultrasound (3D TVUS) may be a valuable alternative to MRI in the diagnosis of a uterine septum. However, large prospective studies that examine its diagnostic value are needed to determine the exact role of this technique in the diagnostic work-up of a uterine septum. Moreover, gel infusion sonography (GIS) is already frequently used in gynaecological practice for other intrauterine pathologies. Nevertheless, its added value in the diagnosis of uterine septa has not yet been confirmed in large prospective studies. Objective: Determining the added value of three-dimensional transvaginal ultrasound (3D TVUS) and three-dimensional gel contrast sonohysterography (3D GIS) for diagnosing patients with a suspected uterine septum by analysing sensitivity, specificity, and inter-observer reliability. by determining the sensitivity, specificity and interrater reproducibility.
Ethics approval(s)	Approved 01/10/2025, Commissie voor medische ethiek U(Z) Gent (Corneel Heymanslaan 10, Ghent, 9000, Belgium; +32 (0)9 332 33 36; ethisch.comite@uzgent.be), ref: ONZ-2025-0219
Health condition(s) or problem(s) studied	Diagnosis of patients with a uterine septum
Intervention	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 uterine septum on 2D TVUS during routine consultation: - Informed consent form - Questionnaires EQ-5D-5L and iPCQ via email 2. Follicular phase of the menstrual cycle: - Baseline data collection - 3D TVUS and 3D GIS (by a gynaecologist) 3. 1 week after 3D TVUS/ 3D GIS: - TMI questionnaires concerning patient experience of 3D TVUS and 3D GIS via telephone (by study nurse) 4. Within 12 weeks after inclusion: - Pelvic MRI (by radiologist) 5. 1 week after MRI: - TMI questionnaire concerning patient experience of MRI via telephone (by study nurse) 6. After completion of all diagnostic tests (within 14 weeks after inclusion) - Definitive diagnosis via telephone (by a gynaecologist) - Questionnaires EQ-5D-5L and iPCQ via email
Intervention type	Other
Primary outcome measure	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 outcome measures	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.
Overall study start date	01/01/2025
Completion date	31/12/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	45 Years
Sex	Female
Target number of participants	145
Key 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
Key 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
Date of first enrolment	20/10/2025
Date of final enrolment	31/12/2028

Locations

Countries of recruitment

Belgium

Study participating centres

Ghent University Hospital

Corneel Heymanslaan 10
Ghent
9000
Belgium

AZ Sint-Lucas Brugge

Sint-Lucaslaan 29
Brugge
8310
Belgium

AZ Sint-Jan Brugge

Ruddershove 10
Brugge
8000
Belgium

UZ Brussel

Laarbeeklaan 101
Jette
1090
Belgium

ZAS

Kempenstraat 100
Antwerpen
2030
Belgium

ZOL

Synaps park 1
Genk
3600
Belgium

AZORG

Moorselbaan 164
Aalst
9300
Belgium

Sponsor information

Ghent University Hospital
Hospital/treatment centre

Corneel Heymanslaan 10
Ghent
9000
Belgium

Phone	+32 9 332 05 30
Email	hiruz@uzgent.be
Website	https://www.uzgent.be/
"ROR"	https://ror.org/00xmkp704

Funders

Funder type

Research organisation

Fonds Wetenschappelijk Onderzoek
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Research Foundation Flanders, Flemish Research Foundation, The FWO, Het FWO, FWO
Location: Belgium

Results and Publications

Intention to publish date	31/12/2029
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

17/10/2025: Study's existence confirmed by the Medical Ethics Committee Ghent University Hospital, Belgium.