Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02984774
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Nigar Sofiyeva, 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.

Condition or disease Intervention/treatment Phase
Endometriosis Ovaries Infertility, Female Procedure: Cystectomy Procedure: Endometrial sampling Procedure: Peripheric blood sampling Procedure: Ovarian tissue sampling Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum
Study Start Date : June 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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

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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Age in years [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis

  2. Marital status (single, married, divorced, widow) [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis

  3. Smoking status ( yes/no) [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis

  4. BMI in kg/m2 [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis

  5. Cystic size in cm [ Time Frame: During operation ]
    Macroscopically assessment during surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984774


Locations
Layout table for location information
Turkey
Nigar Sofiyeva
Istanbul, Non-US/Non-Canadian, Turkey, 34098
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Study Director: Engin Oral, MD Istanbul University

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Nigar Sofiyeva, Resident Doctor, Istanbul University
ClinicalTrials.gov Identifier: NCT02984774     History of Changes
Other Study ID Numbers: 53684
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: General results is available for sharing.
Keywords provided by Nigar Sofiyeva, Istanbul University:
Endometriosis
Infertility
Telomerase activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Endometriosis
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs