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

Observational Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endometrial fluid, Endometrial biopsy, Follicular fluid.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test Endometrial fluid
    Endometrial fluid collection in the day of OPU
  • Diagnostic test Endometrial biopsy
    Endometrial biopsy on the OPU day, Pipelle
  • Diagnostic test Follicular fluid
    Follicular fluid sampling on the OPU day

Primary outcome measures

  • Relative expression levels (e.g., fold change, normalized intensity, or concentration in pg/mL/ng/mL depending on biomarker assay) [Time frame: 2 years]
  • Percentage of blastoids successfully implanted in vitro (% implantation rate) [Time frame: 2 years]
Secondary outcome measures (1)
  • Relative expression levels (e.g., concentration in pg/mL, ng/mL, or fold change depending on assay) [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska Institute and Karolinska University Hospital Huddinge — Stockholm

Identifiers

NCT: NCT07182643 · 2025-03224-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗