Innovative Non-Invasive Diagnostics and Personalized Treatment Strategies for Endometriosis Through Advanced Multi-Omics and Ultrasound Integration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive diagnosis of endometriosis.
- Who it may be relevant to
- Registry conditions: Endometriosis, Infertility, Female. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
Overview
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.
Interventions
- Diagnostic test Non-invasive diagnosis of endometriosis
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
Primary outcome measures
- Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis [Time frame: At baseline diagnostic evaluation]
Secondary outcome measures (5)
- Diagnostic accuracy of AI-assisted transvaginal ultrasound alone [Time frame: Baseline]
- Diagnostic performance of plasma and endometrial biomarker panel [Time frame: 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)]
- Molecular characteristics associated with embryo/blastoid attachment [Time frame: 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)]
Eligibility criteria
Inclusion criteria
- Women aged 18-45
- Understands and speaks the Swedish language
- Suspected or confirmed endometriosis
Exclusion criteria
- Do not have a uterus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07570225 · DNR 2025-03336-01