EndometriosisNCT07182643
Biomarkers in the Endometrial Fluid, Tissue, and Follicular Fluid of Moderate/Severe Endometriosis Patients
An observational study of Endometriosis, run by Region Stockholm at 1 site in Sweden.
Trial summary
This study aims to explore biomarkers in the endometrial fluid and tissue of women with moderate to severe endometriosis, with a specific focus on those involved in pre-receptive endometrium and embryo implantation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Endometrial fluid, Endometrial biopsy and Follicular fluid
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2025to 31 Dec 2027
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: We are going to recruit 30 patients who undergo fertility preservation or fertility treatment before endometriosis surgery in the Reproductive Medicine Clinic in Karolinska University Hospital. Our patients are diagnosed with stage III/IV endometriosis according to rASRM staging by using ultrasound. The control group will consist of 60 healthy women without endometriosis signs in the ultrasound who present to our clinic as oocyte donors or for fertility treatment because of male factor or pregenetic testing for genetic diseases of the partner
Who may be able to join
- Age 18-40 years old
- Diagnosed with moderate/severe endometriosis by ultrasound or laparoscopy (patient group)
- Regular menstrual cycles 28-35 days
- Speak English or Swedish and agree to participate in the study
Who cannot join
- Pregnancy or lactation in the last 3 months
- Uterine anomalies
- Pelvic inflammatory disease, endometritis, STD
- Gynaecological cancers or other malignancies in the patient's history
- Smoking (more than 10 cigarettes per day) or alcohol abuse
- Immunosuppressing medicines
- Major abdominal or pelvic surgery in the last 3 months
- A specific genetic disease that is diagnosed before PGT in women undergoing treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenny Rodriguez-Wallberg, Professor contact
Sweden1 site
Karolinska Institute and Karolinska University Hospital Huddinge
Stockholm, 14433
Anastasia Drakou, MSc, PhD student, 0735500118, anastasiadrakou1989@gmail.com
anastasiadrakou1989@gmail.com
About this study
Official title: An Exploratory Study of Biomarkers in the Endometrial Fluid, Tissue, and Follicular Fluid of Moderate/Severe Endometriosis Patients: a Prospective Study
This study aims to explore biomarkers in the endometrial fluid and tissue of women with moderate to severe endometriosis, with a specific focus on those involved in pre-receptive endometrium and embryo implantation. This research has the potential to uncover diagnostic indicators of impaired pre-receptive endometrium, examine pathophysiological pathways, and identify future targets for therapeutic intervention. Ultimately, the findings may contribute to more personalized fertility treatments, offering new hope for women struggling with endometriosis-related infertility.
- Conditions
- Endometriosis
- Being tested
- Endometrial fluid, Endometrial biopsy, Follicular fluid
- Keywords
- endometriosis, biomarkers, implantation, infertility, fertility
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial fluidDiagnostic test
Endometrial fluid collection in the day of OPU
Endometrial biopsyDiagnostic test
Endometrial biopsy on the OPU day, Pipelle
Follicular fluidDiagnostic test
Follicular fluid sampling on the OPU day
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis | Moderate/severe endometriosis Receives: Diagnostic Test: Endometrial fluid; Diagnostic Test: Endometrial biopsy; Diagnostic Test: Follicular fluid | |
| Controls | Healthy women undergoing oocyte pick up Receives: Diagnostic Test: Endometrial fluid; Diagnostic Test: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative expression levels (e.g., fold change, normalized intensity, or concentration in pg/mL/ng/mL depending on biomarker assay)
Evaluation of the expression levels of selected biomarkers in endometrial fluid samples from patients with moderate to severe endometriosis compared to healthy controls.
Measured: 2 years
Percentage of blastoids successfully implanted in vitro (% implantation rate)
Evaluation of the implantation efficiency of blastoids in vitro (endometrial organoids) under controlled laboratory conditions.
Measured: 2 years
Secondary outcomes (1)
Relative expression levels (e.g., concentration in pg/mL, ng/mL, or fold change depending on assay)
Assessment of biomarker expression levels in follicular fluid samples from follicles in different distances from endometriomas in patients with severe endometriosis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kenny Rodriguez-Wallberg, Professor, Principal investigator, Onk/Pat Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182643
- Sponsor's protocol ID
- 2025-03224-01
- Other IDs
- 2025
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Biomarkers in the Endometrial Fluid, Tissue, and Follicular Fluid of Moderate/Severe Endometriosis Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT07182643
- Acronym / sponsor ID
- 2025-03224-01
- Conditions
- Endometriosis
- Keywords
- endometriosis, biomarkers, implantation, infertility, fertility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
This study aims to explore biomarkers in the endometrial fluid and tissue of women with moderate to severe endometriosis, with a specific focus on those involved in pre-receptive endometrium and embryo implantation. This research has the potential to uncover diagnostic indicators of impaired pre-receptive endometrium, examine pathophysiological pathways, and identify future targets for therapeutic intervention. Ultimately, the findings may contribute to more personalized fertility treatments, offering new hope for women struggling with endometriosis-related infertility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis | – | Diagnostic Test: Endometrial fluid, Diagnostic Test: Endometrial biopsy, Diagnostic Test: Follicular fluidModerate/severe endometriosis |
| Controls | – | Diagnostic Test: Endometrial fluid, Diagnostic Test: Endometrial biopsyHealthy women undergoing oocyte pick up |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We are going to recruit 30 patients who undergo fertility preservation or fertility treatment before endometriosis surgery in the Reproductive Medicine Clinic in Karolinska University Hospital. Our patients are diagnosed with stage III/IV endometriosis according to rASRM staging by using ultrasound. The control group will consist of 60 healthy women without endometriosis signs in the ultrasound who present to our clinic as oocyte donors or for fertility treatment because of male factor or pregenetic testing for genetic diseases of the partner
Key inclusion criteria (4 listed)
- Age 18-40 years old
- Diagnosed with moderate/severe endometriosis by ultrasound or laparoscopy (patient group)
- Regular menstrual cycles 28-35 days
- Speak English or Swedish and agree to participate in the study
Key exclusion criteria (8 listed)
- Pregnancy or lactation in the last 3 months
- Uterine anomalies
- Pelvic inflammatory disease, endometritis, STD
- Gynaecological cancers or other malignancies in the patient's history
- Smoking (more than 10 cigarettes per day) or alcohol abuse
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 |
|---|---|---|
| Endometrial fluidEndometrial fluid collection in the day of OPU | Diagnostic test | Controls, Endometriosis |
| Endometrial biopsyEndometrial biopsy on the OPU day, Pipelle | Diagnostic test | Controls, Endometriosis |
| Follicular fluidFollicular fluid sampling on the OPU day | Diagnostic test | Endometriosis |
Primary outcome
Relative expression levels (e.g., fold change, normalized intensity, or concentration in pg/mL/ng/mL depending on biomarker assay)
Time frame: 2 years
Evaluation of the expression levels of selected biomarkers in endometrial fluid samples from patients with moderate to severe endometriosis compared to healthy controls.
Percentage of blastoids successfully implanted in vitro (% implantation rate)
Time frame: 2 years
Evaluation of the implantation efficiency of blastoids in vitro (endometrial organoids) under controlled laboratory conditions.
1 secondary outcome
Relative expression levels (e.g., concentration in pg/mL, ng/mL, or fold change depending on assay)
Time frame: 2 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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Endometriosis
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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.
Kenny Rodriguez-Wallberg, Professor contact
Kenny Rodriguez-Wallberg, Professor principal investigator
Onk/Pat Karolinska Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 8 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Anastasia Drakou, MSc, PhD student (+46735500118, anastasiadrakou1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative expression levels (e.g., fold change, normalized intensity, or concentration in pg/mL/ng/mL depending on biomarker assay) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 19 Sep 2025.