EndometriosisENDO-NOVANCT07570225
Innovative Non-Invasive Diagnostics and Personalized Treatment Strategies for Endometriosis Through Advanced Multi-Omics and Ultrasound Integration
An observational study of Endometriosis and Infertility, Female, run by Region Stockholm.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Infertility, Female
- What is being tested?
- Non-invasive diagnosis of endometriosis
- How many people
- 365 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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
Who may be able to join
- Women aged 18-45
- Understands and speaks the Swedish language
- Suspected or confirmed endometriosis
Who cannot join
- Do not have a uterus
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
This project aims to develop a non-invasive diagnostic strategy by integrating:
- AI-enhanced TVUS for improved lesion detection.
- Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling.
- Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction.
- 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.
- Conditions
- Endometriosis, Infertility, Female
- Being tested
- Non-invasive diagnosis of endometriosis
- Keywords
- Transvaginal ultrasound, AI, Multi-omics, Organoid
- Medical subject headings
- Endometriosis, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive diagnosis of endometriosisDiagnostic test
Diagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids
| Study group | Role | What they receive |
|---|---|---|
| 1 | Never had treatment Receives: Diagnostic Test: Non-invasive diagnosis of endometriosis | |
| 2 | Ongoing treatment Receives: Diagnostic Test: Non-invasive diagnosis of endometriosis | |
| 3 | No actual treatment (has had treatment before) Receives: Diagnostic Test: Non-invasive diagnosis of endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis
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.
Measured: At baseline diagnostic evaluation
Secondary outcomes (5)
Diagnostic accuracy of AI-assisted transvaginal ultrasound alone
To evaluate the performance of AI-assisted transvaginal ultrasound (TVUS) for detection and classification of endometriosis lesions.
Measured: Baseline
Diagnostic performance of plasma and endometrial biomarker panel
To assess the ability of plasma and endometrial-derived biomarkers to detect endometriosis, disease stage, and correlate to clinical symptoms.
Measured: Baseline sample collection
Implantation rate in in vitro endometrial models
To compare the attachment rate of embryo-derived or stem cell-derived embryonic structures (blastoids) to endometrial tissue from women with and without endometriosis.
Measured: Periprocedural/ During in vitro culture period (e.g., up to 5-10 days)
Molecular characteristics associated with embryo/blastoid attachment
To evaluate transcriptomic and hormonal differences between successfully and unsuccessfully attaching embryos or blastoids.
Measured: Periprocedural/During in vitro experiments
Organoid drug response variability and association with disease characteristics
To evaluate variability in response to hormonal and immune-targeted therapies in organoids and association with disease severity.
Measured: At baseline sample collection and through study completion (around 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Apr 2028 (estimated)
- Study completion20 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Ronak Perot, MD, Study chair, Region StockholmLars Henningsohn, MD,Prof, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570225
- Sponsor's protocol ID
- DNR 2025-03336-01
- Acronym
- ENDO-NOVA
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovativa Icke-invasiva Diagnostiska Och Personliga Behandlingsstrategier för Endometrios Genom Avancerad Multi-omik Och Ultraljudsintegration
- ClinicalTrials.gov ID
- NCT07570225
- Acronym / sponsor ID
- ENDO-NOVA / DNR 2025-03336-01
- Conditions
- Endometriosis, Infertility, Female
- Keywords
- Transvaginal ultrasound, AI, Multi-omics, Organoid
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2028 (estimated)
- Study completion
- 20 Apr 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- AI-enhanced TVUS for improved lesion detection.
- Multi-omics biomarker discovery through proteomics, transcriptomics, and immune profiling.
- Underpinning the mechanisms of reduced endometrial receptivity in endometriosis using an in vitro model of embryo-endometrium interaction.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Non-invasive diagnosis of endometriosisNever had treatment |
| 2 | – | Diagnostic Test: Non-invasive diagnosis of endometriosisOngoing treatment |
| 3 | – | Diagnostic Test: Non-invasive diagnosis of endometriosisNo actual treatment (has had treatment before) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Women aged 18-45
- Understands and speaks the Swedish language
- Suspected or confirmed endometriosis
Key exclusion criteria (1 listed)
- Do not have a uterus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive diagnosis of endometriosisDiagnosis using AI-enhanced transvaginal ultrasound, multi-omics, and organoids | Diagnostic test | 1, 2, 3 |
Primary outcome
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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
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Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
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Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
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Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronak Perot, MD study chair
Region Stockholm
Lars Henningsohn, MD,Prof study chair
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Infertility, Female, run by Region Stockholm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefhanie Romero Andersson, MD, PhD, MSc (0046707822742, stefhanie.romero.andersson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the combined AI-assisted transvaginal ultrasound and multi-omics biomarker model for detection of endometriosis (time frame: At baseline diagnostic evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.