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NCT Number: NCT07182643

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska Institute and Karolinska University Hospital Huddinge

Stockholm, 14433, Sweden

Location contact

Anastasia Drakou, MSc, PhD student

CONTACT

[email protected]

0735500118

Anastasia Drakou, MSc, PhD student

SUB_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endometrial fluid

Diagnostic Test

Endometrial fluid collection in the day of OPU

Endometrial Biopsy

Diagnostic Test

Endometrial biopsy on the OPU day, Pipelle

Follicular fluid

Diagnostic Test

Follicular fluid sampling on the OPU day

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: 2 years

    Assessment of biomarker expression levels in follicular fluid samples from follicles in different distances from endometriomas in patients with severe endometriosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Anastasia Drakou, MSc, PhD student

CONTACT

[email protected]

+46735500118

Kenny Rodriguez-Wallberg, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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