Biomarkers in Endometriosis

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Diagnostic test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary infertility or endometriosis with clinical indication for surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endometriosis; 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.	Diagnostic test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample; All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.
Primary infertility; 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.	Diagnostic test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample; All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics	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.	3 years to collect all speciments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis	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.	3 years to collect all speciments

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana
• Investigators: Principal Investigator: Vid Jansa, MD, UKCLjubljana

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: October 11, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Endometriosis; Biomarkers
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: BEND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No