Biomarkers in Endometriosis

NCT04591548 | Completed

• 1 other identifier: BEND
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Keywords

Endometriosis; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis

  3 years to collect all speciments

Study Arms (2)

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

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

Interventions

proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample DIAGNOSTIC_TEST

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.

Endometriosis; Primary infertility

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Gynecological condition
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

peritoneal fluid precipitate, serum precipitate, uterine fluid precipitate

MeSH Terms

Conditions

Endometriosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vid Jansa, MD

  UKCLjubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2020
• First Posted: October 19, 2020
• Study Start: May 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share