Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients

Not Applicable

Completed

• Conditions: Infertility, Female; Endometriosis Ovaries
• Interventions: Procedure: Cystectomy; Procedure: Endometrial sampling; Procedure: Ovarian tissue sampling; Procedure: Peripheric blood sampling

• Registration Number: NCT02984774
• Lead Sponsor: Istanbul University

Brief Summary

The goal of the study was the detection of telomerase activity in eutopic, ectopic endometrial tissue and in peripheral blood and finding the correlation between the telomerase activity and clinic findings. With these results, confirmation of the hypothesis regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.

Detailed Description

Although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial.

Endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. Hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. On the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells.

In this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed.

Before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. But evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed.

Correlation of telomerase activity and endometriosis-related infertility was aimed in this study.

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-03
• Last Update Submitted: 2016-12-03
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria

Malign disorders Hormone replacement treatment Oral Contraceptive using

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fertile endometriosis	Endometrial sampling	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Control	Ovarian tissue sampling	Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.
Infertile endometriosis	Endometrial sampling	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Fertile endometriosis	Cystectomy	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Infertile endometriosis	Cystectomy	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Infertile endometriosis	Peripheric blood sampling	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Control	Peripheric blood sampling	Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.
Fertile endometriosis	Peripheric blood sampling	Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Control	Endometrial sampling	Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.

Primary Outcome Measures

Name	Time	Method
Telomerase activity	through study completion, an average of 1 year	Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood

Secondary Outcome Measures

Name	Time	Method
Age in years	During admission to hospital for surgery	From patient anamnesis
Smoking status ( yes/no)	During admission to hospital for surgery	From patient anamnesis
Marital status (single, married, divorced, widow)	During admission to hospital for surgery	From patient anamnesis
BMI in kg/m2	During admission to hospital for surgery	From patient anamnesis
Cystic size in cm	During operation	Macroscopically assessment during surgery

Trial Locations

Locations (1)

Nigar Sofiyeva; 🇹🇷 Istanbul, Non-US/Non-Canadian, Turkey