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

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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

Tracking Information
First Submitted Date  ICMJE December 1, 2016
First Posted Date  ICMJE December 7, 2016
Last Update Posted Date December 7, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2016)
  • Age in years [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis
  • Marital status (single, married, divorced, widow) [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis
  • Smoking status ( yes/no) [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis
  • BMI in kg/m2 [ Time Frame: During admission to hospital for surgery ]
    From patient anamnesis
  • Cystic size in cm [ Time Frame: During operation ]
    Macroscopically assessment during surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients
Official Title  ICMJE Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Endometriosis Ovaries
  • Infertility, Female
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Infertile endometriosis
    Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
    Interventions:
    • Procedure: Cystectomy
    • Procedure: Endometrial sampling
    • Procedure: Peripheric blood sampling
  • Experimental: Fertile endometriosis
    Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
    Interventions:
    • Procedure: Cystectomy
    • Procedure: Endometrial sampling
    • Procedure: Peripheric blood sampling
  • Control
    Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.
    Interventions:
    • Procedure: Endometrial sampling
    • Procedure: Peripheric blood sampling
    • Procedure: Ovarian tissue sampling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2016)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02984774
Other Study ID Numbers  ICMJE 53684
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: General results is available for sharing.
Responsible Party Nigar Sofiyeva, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Engin Oral, MD Istanbul University
PRS Account Istanbul University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP