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

Primary Purpose

Endometriosis Ovaries, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cystectomy
Endometrial sampling
Peripheric blood sampling
Ovarian tissue sampling
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis Ovaries focused on measuring Endometriosis, Infertility, Telomerase activity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using

Sites / Locations

  • Nigar Sofiyeva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Infertile endometriosis

Fertile endometriosis

Control

Arm Description

Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.

Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.

Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.

Outcomes

Primary Outcome Measures

Telomerase activity
Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood

Secondary Outcome Measures

Age in years
From patient anamnesis
Marital status (single, married, divorced, widow)
From patient anamnesis
Smoking status ( yes/no)
From patient anamnesis
BMI in kg/m2
From patient anamnesis
Cystic size in cm
Macroscopically assessment during surgery

Full Information

First Posted
December 1, 2016
Last Updated
December 3, 2016
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT02984774
Brief Title
Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Ovaries, Infertility, Female
Keywords
Endometriosis, Infertility, Telomerase activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infertile endometriosis
Arm Type
Experimental
Arm Description
Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Arm Title
Fertile endometriosis
Arm Type
Experimental
Arm Description
Cystic wall segment from cystectomy material, endometrial sampling during the surgery and peripheric blood sampling during intravenous catheterization during anesthesia.
Arm Title
Control
Arm Type
Other
Arm Description
Ovarian tissue sampling, endometrial sampling from hysterectomy and oophorectomy pieces and peripheric blood sampling during intravenous catheterization during anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Cystectomy
Intervention Description
Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis
Intervention Type
Procedure
Intervention Name(s)
Endometrial sampling
Other Intervention Name(s)
Pipelle endometrial suction curettage
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Peripheric blood sampling
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Ovarian tissue sampling
Intervention Description
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 Measure Information:
Title
Telomerase activity
Description
Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Age in years
Description
From patient anamnesis
Time Frame
During admission to hospital for surgery
Title
Marital status (single, married, divorced, widow)
Description
From patient anamnesis
Time Frame
During admission to hospital for surgery
Title
Smoking status ( yes/no)
Description
From patient anamnesis
Time Frame
During admission to hospital for surgery
Title
BMI in kg/m2
Description
From patient anamnesis
Time Frame
During admission to hospital for surgery
Title
Cystic size in cm
Description
Macroscopically assessment during surgery
Time Frame
During operation

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis Exclusion Criteria: Malign disorders Hormone replacement treatment Oral Contraceptive using
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Engin Oral, MD
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Nigar Sofiyeva
City
Istanbul
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
General results is available for sharing.
Citations:
PubMed Identifier
6420199
Citation
Schenken RS, Asch RH, Williams RF, Hodgen GD. Etiology of infertility in monkeys with endometriosis: luteinized unruptured follicles, luteal phase defects, pelvic adhesions, and spontaneous abortions. Fertil Steril. 1984 Jan;41(1):122-30. doi: 10.1016/s0015-0282(16)47552-7.
Results Reference
background
PubMed Identifier
11821289
Citation
Bedaiwy MA, Falcone T, Sharma RK, Goldberg JM, Attaran M, Nelson DR, Agarwal A. Prediction of endometriosis with serum and peritoneal fluid markers: a prospective controlled trial. Hum Reprod. 2002 Feb;17(2):426-31. doi: 10.1093/humrep/17.2.426.
Results Reference
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PubMed Identifier
12566749
Citation
Pizzo A, Salmeri FM, Ardita FV, Sofo V, Tripepi M, Marsico S. Behaviour of cytokine levels in serum and peritoneal fluid of women with endometriosis. Gynecol Obstet Invest. 2002;54(2):82-7. doi: 10.1159/000067717.
Results Reference
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PubMed Identifier
11163805
Citation
Lebovic DI, Mueller MD, Taylor RN. Immunobiology of endometriosis. Fertil Steril. 2001 Jan;75(1):1-10. doi: 10.1016/s0015-0282(00)01630-7.
Results Reference
background
PubMed Identifier
12532021
Citation
Genbacev OD, Prakobphol A, Foulk RA, Krtolica AR, Ilic D, Singer MS, Yang ZQ, Kiessling LL, Rosen SD, Fisher SJ. Trophoblast L-selectin-mediated adhesion at the maternal-fetal interface. Science. 2003 Jan 17;299(5605):405-8. doi: 10.1126/science.1079546.
Results Reference
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PubMed Identifier
12735387
Citation
Cunha-Filho JS, Gross JL, Bastos de Souza CA, Lemos NA, Giugliani C, Freitas F, Passos EP. Physiopathological aspects of corpus luteum defect in infertile patients with mild/minimal endometriosis. J Assist Reprod Genet. 2003 Mar;20(3):117-21. doi: 10.1023/a:1022625106489.
Results Reference
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PubMed Identifier
16167942
Citation
Kissler S, Hamscho N, Zangos S, Gatje R, Muller A, Rody A, Dobert N, Menzel C, Grunwald F, Siebzehnrubl E, Kaufmann M. Diminished pregnancy rates in endometriosis due to impaired uterotubal transport assessed by hysterosalpingoscintigraphy. BJOG. 2005 Oct;112(10):1391-6. doi: 10.1111/j.1471-0528.2005.00676.x.
Results Reference
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PubMed Identifier
9846988
Citation
Tanaka M, Kyo S, Takakura M, Kanaya T, Sagawa T, Yamashita K, Okada Y, Hiyama E, Inoue M. Expression of telomerase activity in human endometrium is localized to epithelial glandular cells and regulated in a menstrual phase-dependent manner correlated with cell proliferation. Am J Pathol. 1998 Dec;153(6):1985-91. doi: 10.1016/S0002-9440(10)65712-4.
Results Reference
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PubMed Identifier
11502832
Citation
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Results Reference
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PubMed Identifier
17077107
Citation
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Results Reference
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PubMed Identifier
18456668
Citation
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Results Reference
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Citation
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Results Reference
result

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

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