Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03924648
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2019-04-16
Brief Title:
Endocan Levels in Women With Premature Ovarian Insufficiency
Sponsor:
Cengiz Gokcek Womens and Childrens Hospital
Organization:
Cengiz Gokcek Womens and Childrens Hospital
Study Overview
Official Title:
Endothelial Cell Specific Molecule-1 Endocan Levels in Women With Premature Ovarian Insufficiency
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndocanPOI
Brief Summary:
Objective To evaluate serum endocan levels in women with premature ovarian insufficiency POI and to compare the results with those of healthy subjects
Methods This prospective study included 38 women with idiopathic POI and 39 controls The blood for analysis was obtained at the early follicular phase of the menstrual cycle and serum endocan levels were measured using a commercially available ELISA kit Follicle-stimulating hormone FSH estradiol and anti-mullerian hormone AMH were measured at the same time The continuous values were evaluated using Students t-test and categorical values were evaluated using the Chi-square test P values 05 were accepted as significant
Methods This prospective study included 38 women with idiopathic POI and 39 controls The blood for analysis was obtained at the early follicular phase of the menstrual cycle and serum endocan levels were measured using a commercially available ELISA kit Follicle-stimulating hormone FSH estradiol and anti-mullerian hormone AMH were measured at the same time The continuous values were evaluated using Students t-test and categorical values were evaluated using the Chi-square test P values 05 were accepted as significant
Detailed Description:
Study design This was an observational prospective cohort study conducted at Obstetrics and Gynecology Department of Cengiz Gokcek Obstetrics and Childrens Hospital between July and December 2018 Seventy-seven women were enrolled in the study in two groups All patients gave their oral and written informed consent before their inclusion in the study The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University Reference number 201864 The study strictly adhered to the principles of the Declaration of Helsinki
Data collection and Study intervention
At enrollment for both groups we collected data about age height weight BMI age of menarche obstetrics history history of smoking regular exercise and family history of POI The investigators defined that POI period is a time from diagnosis to admission At enrolment all patients underwent vaginal ultrasonography for the assessment of antral follicle count AFC and venous blood sample from the antecubital veins for measuring serum concentration of Endocan Follicle-stimulating hormone FSH E2 anti-mullerian hormone AMH and complete blood count CBC In control subjects venous blood samples and AFC were collected during the early follicular phase of the menstrual cycle 2nd to 5th days in the morning between 0800 and 0900 h In the POI group measurements were repeated with 4-week intervals AMH was not measured in the control group AFC were assessed through vaginal ultrasonography by the same author Mindray DC-7T ultrasound machine Shenzen-Mindray Bio-Medical Electronics Co Ltd China Blood samples were separated by centrifugation for 10 minutes at 1500 g after clotting for 30 minutes at room temperature The serum samples were subsequently stored in aliquots at -80C prior to the analysis of endocan The serum endocan level was measured using a commercially available enzyme-linked immunosorbent assay ELISA kit which is produced to detect human endocan levels with high sensitivity and specificity Elabscience Biotechnology Inc Houston TX USA The endocan measurements were performed in accordance with companys protocol The kit uses the sandwich ELISA principle A biotinylated detection antibody specific for human ESM1 endocan and avidin-horseradish peroxidase conjugate were used in the measurement Spectrophotometry at a wave length of 450 2 nm was used in the detection of optical density which is proportional to the concentration of human endocan level The intra- and inter-assay variation coefficients were 636 and 609 respectively
Endpoints of the study
The primary endpoint in this analysis was to compare endocan levels in POI group and control group The secondary endpoint was to compare endocan levels in POI group for POI period Tertiary endpoint was to compare the endocan levels in both groups according to the births
The normality of distribution of continuous variables was tested using the Shapiro-Wilk test To compare numerical variables between 2 groups Students t-test for normal data or the Mann-Whitney U test for non-normal data was performed The Chi-square test was used to assess the relationship between categorical variables and Spearmans rank correlation coefficients were used to assess the relationship between non-normal numeric data Frequency percentage and mean standard deviations mean SD are given as descriptive statistics Statistical analysis was performed using the SPSS for Windows version 240 software package and p valued 005 were accepted as statistically significant
Data collection and Study intervention
At enrollment for both groups we collected data about age height weight BMI age of menarche obstetrics history history of smoking regular exercise and family history of POI The investigators defined that POI period is a time from diagnosis to admission At enrolment all patients underwent vaginal ultrasonography for the assessment of antral follicle count AFC and venous blood sample from the antecubital veins for measuring serum concentration of Endocan Follicle-stimulating hormone FSH E2 anti-mullerian hormone AMH and complete blood count CBC In control subjects venous blood samples and AFC were collected during the early follicular phase of the menstrual cycle 2nd to 5th days in the morning between 0800 and 0900 h In the POI group measurements were repeated with 4-week intervals AMH was not measured in the control group AFC were assessed through vaginal ultrasonography by the same author Mindray DC-7T ultrasound machine Shenzen-Mindray Bio-Medical Electronics Co Ltd China Blood samples were separated by centrifugation for 10 minutes at 1500 g after clotting for 30 minutes at room temperature The serum samples were subsequently stored in aliquots at -80C prior to the analysis of endocan The serum endocan level was measured using a commercially available enzyme-linked immunosorbent assay ELISA kit which is produced to detect human endocan levels with high sensitivity and specificity Elabscience Biotechnology Inc Houston TX USA The endocan measurements were performed in accordance with companys protocol The kit uses the sandwich ELISA principle A biotinylated detection antibody specific for human ESM1 endocan and avidin-horseradish peroxidase conjugate were used in the measurement Spectrophotometry at a wave length of 450 2 nm was used in the detection of optical density which is proportional to the concentration of human endocan level The intra- and inter-assay variation coefficients were 636 and 609 respectively
Endpoints of the study
The primary endpoint in this analysis was to compare endocan levels in POI group and control group The secondary endpoint was to compare endocan levels in POI group for POI period Tertiary endpoint was to compare the endocan levels in both groups according to the births
The normality of distribution of continuous variables was tested using the Shapiro-Wilk test To compare numerical variables between 2 groups Students t-test for normal data or the Mann-Whitney U test for non-normal data was performed The Chi-square test was used to assess the relationship between categorical variables and Spearmans rank correlation coefficients were used to assess the relationship between non-normal numeric data Frequency percentage and mean standard deviations mean SD are given as descriptive statistics Statistical analysis was performed using the SPSS for Windows version 240 software package and p valued 005 were accepted as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None