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Biomarkers in Endometriosis

Biomarkers in Endometriosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04591548
Enrollment
100
Registered
2020-10-19
Start date
2016-05-01
Completion date
2021-01-01
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis, Biomarkers

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.

Interventions

DIAGNOSTIC_TESTproteomic 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.

Sponsors

University of Ljubljana
CollaboratorOTHER
University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Derivation of the panel of proteins indicative of endometriosis using comparative proteomics3 years to collect all specimentsThe 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

MeasureTime frameDescription
Concentrations of proteins in body fluids to validate the identified panel of proteins indicative of endometriosis3 years to collect all specimentsUsing 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026