Innovative Non-Invasive Diagnostics and Personalized Treatment Strategies for Endometriosis Through Advanced Multi-Omics and Ultrasound Integration (ENDO-NOVA)

April 29, 2026 updated by: Region Stockholm

Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration

Endometriosis is a prevalent gynecological condition affecting approximately 10% of women of reproductive age worldwide. It presents with nonspecific but often severe symptoms, including chronic pelvic pain (in 70% of cases) and infertility (in up to 40% of cases), imposing significant physical, psychological, economic, and societal burdens. Despite its widespread occurrence, the exact etiology and pathogenesis of endometriosis remain unclear, and no definitive cure exists. Early diagnosis and management are crucial for improving patient outcomes; however, major diagnostic delays persist. Current imaging techniques such as transvaginal ultrasound (TVUS) examination and magnetic resonance imaging, along with biochemical markers lack sufficient specificity. Consequently, confirmation of diagnosis still requires surgical procedures under general anesthesia, i.e.

laparoscopy ("key-hole surgery") and tissue biopsy. This delay exacerbates the disease burden and healthcare costs, underscoring the urgent need for non-invasive, precise diagnostic strategies. This project proposes a multi-modal approach integrating advanced ultrasound imaging with novel biomarkers identified via comprehensive multi-omics analyses, including proteomics, transcriptomics, and immune profiling, of patient-derived endometrial organoids. It aims to understand the underlying mechanisms of reduced endometrial receptivity of embryos in patients with endometriosis. Additionally, we will explore personalized treatment strategies by utilizing patient-specific organoids for drug screening and evaluation of treatment response.

This project aims to develop a non-invasive diagnostic strategy by integrating:

  1. AI-enhanced TVUS for improved lesion detection.
  2. Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling.
  3. Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction.
  4. Endometrial organoid models to enable precision medicine-based drug testing. The development of a reliable noninvasive or minimally invasive diagnostic test-or a combination of tests-could revolutionize the diagnostic pathway by reducing delays, avoiding the need for surgery, and facilitating disease monitoring and treatment evaluation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

365

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women aged 18-45 years with suspected or confirmed endometriosis that visit the Endometriosis Centre at the Gynaecology Department at Karolinska University Hospital (KUS), Huddinge

Description

Inclusion Criteria:

  • Women aged 18-45
  • Understands and speaks the Swedish language
  • Suspected or confirmed endometriosis

Exclusion Criteria:

  • Do not have a uterus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Never had treatment
Diagnostic test: Non-invasive diagnosis of endometriosis
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
2
Ongoing treatment
Diagnostic test: Non-invasive diagnosis of endometriosis
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
3
No actual treatment (has had treatment before)
Diagnostic test: Non-invasive diagnosis of endometriosis
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
Time Frame: At baseline diagnostic evaluation
Sensitivity and specificity of a combined diagnostic model integrating AI-assisted interpretation of transvaginal ultrasound images with plasma, saliva, urine, and endometrial-derived biomarkers for the detection of endometriosis, using laparoscopic diagnosis with or without histological confirmation as the reference standard.
At baseline diagnostic evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of AI-assisted transvaginal ultrasound alone
Time Frame: Baseline
To evaluate the performance of AI-assisted transvaginal ultrasound (TVUS) for detection and classification of endometriosis lesions.
Baseline
Diagnostic performance of plasma and endometrial biomarker panel
Time Frame: Baseline sample collection
To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms.
Baseline sample collection
Implantation rate in in vitro endometrial models
Time Frame: Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
To compare the attachment rate of embryo-derived or stem cell-derived embryonic structures (blastoids) to endometrial tissue from women with and without endometriosis.
Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
Molecular characteristics associated with embryo/blastoid attachment
Time Frame: Periprocedural/During in vitro experiments
To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids.
Periprocedural/During in vitro experiments
Organoid drug response variability and association with disease characteristics
Time Frame: At baseline sample collection and through study completion (around 3 years)
To evaluate variability in response to hormonal and immune-targeted therapies in organoids and association with disease severity.
At baseline sample collection and through study completion (around 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

Investigators

  • Study Chair: Ronak Perot, MD, Region Stockholm
  • Study Chair: Lars Henningsohn, MD,Prof, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

April 20, 2028

Study Completion (Estimated)

April 20, 2029

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DNR 2025-03336-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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