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NCT Number: NCT07570225

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

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.

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Key information

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Do not have a uterus

Treatment and study plan

Non-invasive diagnosis of endometriosis

Diagnostic Test

Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

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

Stefhanie Romero Andersson, MD, PhD, MSc

CONTACT

[email protected]

0046707822742

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: ENDO-NOVA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 6, 2026
Registry last updated
May 6, 2026

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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