Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls

• Conditions: Endometriosis; Endometrioma

• Registration Number: NCT03687398
• Lead Sponsor: Acibadem University

Brief Summary

Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while other have not.

Detailed Description

Endometriosis is the appearance of a tissue similar to the endometrium in the ovaries, large intestine, and many other organ walls, except the uterus. The reason is unknown yet. Severe periodic pain, infertility, and pain during intercourse, affects approximately 2 million women in Turkey on average, 10% of women around the world. Endometriosis is a chronic inflammatory disease that affects 10-17% of women in childbearing age, 35-60% of women with chronic pelvic pain and can cause infertility, costing as much as 2.8 billion dollars per year. For this reason, every step taken in diagnosis and treatment is of great importance both materially and spiritually. Patients can be diagnosed about 8-9 years after the onset of their complaints due to the inadequacy of diagnostic methods In the study, it is decided to look at the basis of the disease, endometrial cells. And aimed to find the difference between the two women who are thought to be no different from each other among our current knowledge but one has endometriosis while others have not. For this reason, mapping of all genomes with the nanoclonal technique, the most advanced genetic screening method currently available from endometrial samples of patients and healthy women, is to identify the possible copy numbers, translocation, insertion and inversion anomalies, and to name them functionally by proteomic analysis. We believe that the results obtained from our study will guide the diagnostic tests and possible gene therapy in the future.

Study Timeline

• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Study Start: 2018-10-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-06
• Last Update Posted: 2019-07-09
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

surgically diagnosed with endometriosis disease

• no diagnosıs for malignancy
• gave informed consent for application to the study enrolle as patient group females
• between 18-45 years old
• without any health conditions
• applied to the clinic for routine checkups for control group

Exclusion Criteria

• being diagnosed with any kind of malignancy having trouble with endometrial cavity sampling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic testing	2 years	finding a genetic difference which specifically preserved in endometriosis patients but not in healthy controls. To analyse the different region on chromosomes and name the pathophysiology underlying it

Trial Locations

Locations (1)

Bahar Yuksel; 🇹🇷 Istanbul, Turkey