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

ConditionEndometriosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Endometriosis3 interventions
Group B: Controls2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years
2

Percentage of blastoids successfully implanted in vitro (% implantation rate)

Evaluation of the implantation efficiency of blastoids in vitro (endometrial organoids) under controlled laboratory conditions.

Time frame
2 years

Secondary outcomes

1

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

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: