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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Endometrial fluid
Diagnostic testEndometrial fluid collection in the day of OPU
Endometrial biopsy
Diagnostic testEndometrial biopsy on the OPU day, Pipelle
Follicular fluid
Diagnostic testFollicular fluid sampling on the OPU day
Treatment groups
Trial outcomes
Primary outcomes
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.
Percentage of blastoids successfully implanted in vitro (% implantation rate)
Evaluation of the implantation efficiency of blastoids in vitro (endometrial organoids) under controlled laboratory conditions.
Secondary outcomes
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: