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

December 3, 2016 updated by: Nigar Sofiyeva, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Non-US/Non-Canadian
      • Istanbul, Non-US/Non-Canadian, Turkey, 34098
        • Nigar Sofiyeva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infertile endometriosis
Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Procedure: Cystectomy
Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis
Procedure: Endometrial sampling
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
Other Names:
  • Pipelle endometrial suction curettage
Procedure: Peripheric blood sampling
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
Experimental: Fertile endometriosis
Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Procedure: Cystectomy
Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis
Procedure: Endometrial sampling
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
Other Names:
  • Pipelle endometrial suction curettage
Procedure: Peripheric blood sampling
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
Other: Control
Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.
Procedure: Endometrial sampling
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
Other Names:
  • Pipelle endometrial suction curettage
Procedure: Peripheric blood sampling
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
Procedure: Ovarian tissue sampling
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Telomerase activity
Time Frame: 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
through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Engin Oral, MD, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 3, 2016

First Posted (Estimate)

December 7, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 3, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

General results is available for sharing.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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