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

NCT07182643 | Not Yet Recruiting

• 1 other identifier: 2025-03224-01
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

endometriosis; biomarkers; implantation; infertility; fertility

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (1)

• Relative expression levels (e.g., concentration in pg/mL, ng/mL, or fold change depending on assay)

  2 years

Study Arms (2)

Endometriosis

Moderate/severe endometriosis

Diagnostic Test: Endometrial fluid; Diagnostic Test: Endometrial biopsy; Diagnostic Test: Follicular fluid

Controls

Healthy women undergoing oocyte pick up

Diagnostic Test: Endometrial fluid; Diagnostic Test: Endometrial biopsy

Interventions

Endometrial fluid DIAGNOSTIC_TEST

Endometrial fluid collection in the day of OPU

Controls; Endometriosis

Endometrial biopsy DIAGNOSTIC_TEST

Endometrial biopsy on the OPU day, Pipelle

Controls; Endometriosis

Follicular fluid DIAGNOSTIC_TEST

Follicular fluid sampling on the OPU day

Endometriosis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska Institute and Karolinska University Hospital Huddinge

Stockholm, 14433, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Endometrial fluid, follicular fluid, endometrial biopsy, endometriosis lesions biopsy

MeSH Terms

Conditions

Endometriosis; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Kenny Rodriguez-Wallberg, Professor

  Onk/Pat Karolinska Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anastasia Drakou, MSc, PhD student

CONTACT

+46735500118; anastasiadrakou1989@gmail.com

Kenny Rodriguez-Wallberg, Professor

CONTACT

kenny.rodriguez-wallberg@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

SE (1)