Biomarkers in Endometriosis

University Medical Centre Ljubljana

Status: Completed

Conditions: Endometriosis

Treatments: Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample

Study type: Observational

Funder types: Other

Identifiers

NCT04591548

BEND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Endometriosis

Description:

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.

Treatment:

Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample

Primary infertility

Description:

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.

Treatment:

Diagnostic Test: proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample