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Clinical Trials/NCT04591548
NCT04591548
Completed
Not Applicable

Biomarkers in Endometriosis

University Medical Centre Ljubljana0 sites100 target enrollmentMay 1, 2016
ConditionsEndometriosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
University Medical Centre Ljubljana
Enrollment
100
Primary Endpoint
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vid Jansa

Principal Investigator

University Medical Centre Ljubljana

Eligibility Criteria

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

Outcomes

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(3 years to collect all speciments)

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