Biomarkers in the Endometrial Fluid, Tissue, and Follicular Fluid of Moderate/Severe Endometriosis Patients

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT07182643
• Lead Sponsor: Region Stockholm

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative expression levels (e.g., fold change, normalized intensity, or concentration in pg/mL/ng/mL depending on biomarker assay)	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)	2 years	Evaluation of the implantation efficiency of blastoids in vitro (endometrial organoids) under controlled laboratory conditions.

Secondary Outcome Measures

Name	Time	Method
Relative expression levels (e.g., concentration in pg/mL, ng/mL, or fold change depending on assay)	2 years	Assessment of biomarker expression levels in follicular fluid samples from follicles in different distances from endometriomas in patients with severe endometriosis.

Trial Locations

Locations (1)

Karolinska Institute and Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden