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

Sponsor
Istanbul University (Other)
Overall Status
Completed
CT.gov ID
NCT02984774
Collaborator
(none)
47
1
3
26
1.8

Study Details

Study Description

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
  • Procedure: Cystectomy
  • Procedure: Endometrial sampling
  • Procedure: Peripheric blood sampling
  • Procedure: Ovarian tissue sampling
N/A

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 Design

Study Type:
Interventional
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 :
Jun 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Age in years [During admission to hospital for surgery]

      From patient anamnesis

    2. Marital status (single, married, divorced, widow) [During admission to hospital for surgery]

      From patient anamnesis

    3. Smoking status ( yes/no) [During admission to hospital for surgery]

      From patient anamnesis

    4. BMI in kg/m2 [During admission to hospital for surgery]

      From patient anamnesis

    5. Cystic size in cm [During operation]

      Macroscopically assessment during surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

    Exclusion Criteria:

    Malign disorders Hormone replacement treatment Oral Contraceptive using

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nigar Sofiyeva Istanbul Non-US/Non-Canadian Turkey 34098

    Sponsors and Collaborators

    • Istanbul University

    Investigators

    • Study Director: Engin Oral, MD, Istanbul University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nigar Sofiyeva, Resident Doctor, Istanbul University
    ClinicalTrials.gov Identifier:
    NCT02984774
    Other Study ID Numbers:
    • 53684
    First Posted:
    Dec 7, 2016
    Last Update Posted:
    Dec 7, 2016
    Last Verified:
    Dec 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Nigar Sofiyeva, Resident Doctor, Istanbul University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 7, 2016