Biomarkers in Endometriosis

Completed

• Conditions: Endometriosis
• Interventions: Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample

• Registration Number: NCT04591548
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. With the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. Results will be validate using ELISA aproach.

Detailed Description

Informed consent will be obtained from all individual participants included in the study. Blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. Peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. The aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

Study Timeline

• Study Start: 2016-05-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-10-11
• Study First Posted: 2020-10-19
• Study Completion: 2021-01-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• primary infertility
• normal semen analysis of the partner
• normal BMI.

Exclusion Criteria

• hormonal therapy in the last year,
• irregular menstrual cycle,
• previous pelvic surgery,
• history of previous pelvic inflammatory disease,
• smokers and patients with autoimmune diseases,
• malignant or suspected malignant diseases,
• previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometriosis	proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample	All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery.
Primary infertility	proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample	All patients had laparoscopy due to infertility (and endometriosis). All women had BMI in normal range and regular menstrual cycle (21-35 days). Partner's semen analysis was normal in all cases. The investigators excluded patients with hormonal therapy in the last year, irregular menstrual cycle, smokers and patients with autoimmune diseases, malignant or suspected malignant diseases, previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries. None of the patients had previous pelvic surgery.

Primary Outcome Measures

Name	Time	Method
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics	3 years to collect all speciments	The aim of the study is to identify proteins with different levels in cases versus controls these proteins could be new candidates for biomarkers of endometriosis. Differentially expressed proteins are candidates for diagnostic and predictive biomarkers. To identify differentially expresed proteins in discovery phase of the study proteomic aproach will be used.

Secondary Outcome Measures

Name	Time	Method
Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis	3 years to collect all speciments	Using pairs of subjects with and without endometriosis, the derivation of the panel of proteins in body fluids (peritoneal fluid, peripheral blood, uterine fluid samples) gathered through proteomic aproach will be validated using ELISA.