Biomarkers in Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2021-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Endometriosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Endometriosis

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.

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

Intervention Type 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 infertility

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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes