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

An Exploratory Study of Biomarkers in the Endometrial Fluid, Tissue, and Follicular Fluid of Moderate/Severe Endometriosis Patients: a Prospective Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07182643
Enrollment
90
Registered
2025-09-19
Start date
2025-10-01
Completion date
2027-12-31
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

endometriosis, biomarkers, implantation, infertility, fertility

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.

Interventions

DIAGNOSTIC_TESTEndometrial fluid

Endometrial fluid collection in the day of OPU

DIAGNOSTIC_TESTEndometrial biopsy

Endometrial biopsy on the OPU day, Pipelle

DIAGNOSTIC_TESTFollicular fluid

Follicular fluid sampling on the OPU day

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Contacts

Primary ContactAnastasia Drakou, MSc, PhD student
anastasiadrakou1989@gmail.com+46735500118
Backup ContactKenny Rodriguez-Wallberg, Professor
kenny.rodriguez-wallberg@ki.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026