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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum

Conditions
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Endometriosis Ovaries, Infertility, Female

Intervention / Treatment
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* Procedure: Cystectomy
* Procedure: Endometrial sampling
* Procedure: Peripheric blood sampling
* Procedure: Ovarian tissue sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis Exclusion Criteria: Malign disorders Hormone replacement treatment Oral Contraceptive using
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infertile endometriosis<br>Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia. | Procedure: Cystectomy<br>* Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis<br>Procedure: Endometrial sampling<br>* Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis<br>* Other names: Pipelle endometrial suction curettage;Procedure: Peripheric blood sampling<br>* 4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis<br>|
| Experimental: Fertile endometriosis<br>Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia. | Procedure: Cystectomy<br>* Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis<br>Procedure: Endometrial sampling<br>* Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis<br>* Other names: Pipelle endometrial suction curettage;Procedure: Peripheric blood sampling<br>* 4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis<br>|
| Other: Control<br>Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia. | Procedure: Endometrial sampling<br>* Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis<br>* Other names: Pipelle endometrial suction curettage;Procedure: Peripheric blood sampling<br>* 4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis<br>Procedure: Ovarian tissue sampling<br>* 2cm linear tissue sample from ovarian cortex was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Telomerase activity | Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood | through study completion, an average of 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Infertility, Telomerase activity