Biomarkers in Endometriosis

Endometriosis Clinical Trial

Official title:

Biomarkers in Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591548
• Other study ID #: BEND
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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