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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Derivation of the panel of proteins indicative of endometriosis using comparative proteomics

Time frame: 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 outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

University of Ljubljana

Registry information

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2021
First posted: Oct 19, 2020
Registry last updated: Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed