Clinical trial NCT02984774: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis Ovaries
Infertility, Female
Keywords: Endometriosis
Infertility
Telomerase activity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 47
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion Criteria:

Malign disorders Hormone replacement treatment Oral Contraceptive using

Primary outcomes:
measure: Telomerase activity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Age in years
timeFrame: During admission to hospital for surgery
measure: Marital status (single, married, divorced, widow)
timeFrame: During admission to hospital for surgery
measure: Smoking status ( yes/no)
timeFrame: During admission to hospital for surgery
measure: BMI in kg/m2
timeFrame: During admission to hospital for surgery
measure: Cystic size in cm
timeFrame: During operation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Nigar Sofiyeva
state: Non-US/Non-Canadian
Study officials:
affiliation: Istanbul University
name: Engin Oral, MD
role: STUDY_DIRECTOR
References:
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