Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04006171
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2019-06-29
Brief Title:
Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women
Sponsor:
Near East University Turkey
Organization:
Near East University Turkey
Study Overview
Official Title:
C Type Natriuretic Peptide and Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2021-10
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:
CNP
Brief Summary:
Recent studies have shown that C natriuretic peptide is produced from granulosa cells increasing cumulative guanosine monophosphate cGMP production by affecting cumulus cells through natriuretic peptide receptors It is suggested that produced cGMP maintains the transport of oocytes via the gap junctions and leads to a continuous increase in cyclic adenosine monophosphate cAMP levels in the oocyte An important role of increased internal cAMP levels in the oocyte is shown to suppress meiotic progression
Deoxyribonucleic acid studies in animals have shown that expression of the natriuretic peptide precursor increases during the periovulatory period and shows that this increase decreases rapidly after luteinizing hormone human chorionic gonadotropin hCG stimulationHuman studies have shown that after ovulation induction the CNP level in follicular fluid decreases following ovulatory dose of hCGPolycystic ovary syndrome PCOS is the most common endocrine disease in the reproductive period characterized by hyperandrogenism oligo-anovulation and polycystic ovarian morphology on ultrasonography and in an animal study investigating the relationship between CNP and PCOS serum CNP levels were increased in polycystic ovary syndromeCNP serum level is thought to show differences between healthy women and women with polycystic ovary syndrome
Deoxyribonucleic acid studies in animals have shown that expression of the natriuretic peptide precursor increases during the periovulatory period and shows that this increase decreases rapidly after luteinizing hormone human chorionic gonadotropin hCG stimulationHuman studies have shown that after ovulation induction the CNP level in follicular fluid decreases following ovulatory dose of hCGPolycystic ovary syndrome PCOS is the most common endocrine disease in the reproductive period characterized by hyperandrogenism oligo-anovulation and polycystic ovarian morphology on ultrasonography and in an animal study investigating the relationship between CNP and PCOS serum CNP levels were increased in polycystic ovary syndromeCNP serum level is thought to show differences between healthy women and women with polycystic ovary syndrome
Detailed Description:
In this prospective study a total of 60 patients are planed to be included PCOS group will be consisted of 30 women and control group will include 30 healthy women with regular menstruation aged between 18-40 years old PCOS diagnosis will be made according to Rotterdam criteria
Age and body mass index of all participants will be recorded BMI will be calculated by dividing weight by height in square meters Then morning fasting venous blood samples will be taken from the patients between 2nd-5th day of menstruation for both groups All blood samples will be centrifuged on the day of collection Sera will be aliquoted into 15 mL Eppendorf Eppendorf Milano Italy tubes and will be kept at -80C until the day of CNP test For the PCOS patients describing oligoanovulation after excluding pregnancy progesterone withdrawal bleeding will be created and then the patients will be evaluated Serum levels of LH FSH estradiol thyroid stimulating hormone TSH prolactin PRL androstenedione dehydroepiandrosterone sulfate DHEAS total testosterone free testosterone sex hormone binding globulin SHBG total cholesterol TC triglyceride TG high density lipoprotein HDL low density lipoprotein LDL glucose and insulin levels will be analyzed For insulin sensitivity homeostatic model of insulin resistance HOMA-IR will be used and it will be calculated by the formula HOMA-IR ΒΌ fasting blood glucose mgdLfasting insulin mIUmL405 Free androgen index will be calculated by the formula 100x Total testosteronSHBG
Serum CNP levels of the patients will be analyzed by an enzyme-linked immunosorbent ELISA assay for human C-type natriuretic peptide in accordance with the manufacturers instructions SEA721Hu ELISA Kit for Human C-Type Natriuretic Peptide Wuhan USCN Business Co Ltd Cloud-Clone Corp CCC USA
Data will be analyzed using Statistical Packege for Social Sciences software SPSS v15 SPSS Inc Chicago IL USA Independent t-test will be used to compare the parameters with normal distribution Parameters that dont fulfill the parametric test assumptions will be compared using Mann-Whitney U test Correlation of CNP with other parameters will be analyzed using Spearmans rank correlation test Receiver operating characteristic ROC curve will be used to evaluate diagnostic sensitivity and specificity of CNP for PCOS P values less than 005 will be regarded as statistically significant
Age and body mass index of all participants will be recorded BMI will be calculated by dividing weight by height in square meters Then morning fasting venous blood samples will be taken from the patients between 2nd-5th day of menstruation for both groups All blood samples will be centrifuged on the day of collection Sera will be aliquoted into 15 mL Eppendorf Eppendorf Milano Italy tubes and will be kept at -80C until the day of CNP test For the PCOS patients describing oligoanovulation after excluding pregnancy progesterone withdrawal bleeding will be created and then the patients will be evaluated Serum levels of LH FSH estradiol thyroid stimulating hormone TSH prolactin PRL androstenedione dehydroepiandrosterone sulfate DHEAS total testosterone free testosterone sex hormone binding globulin SHBG total cholesterol TC triglyceride TG high density lipoprotein HDL low density lipoprotein LDL glucose and insulin levels will be analyzed For insulin sensitivity homeostatic model of insulin resistance HOMA-IR will be used and it will be calculated by the formula HOMA-IR ΒΌ fasting blood glucose mgdLfasting insulin mIUmL405 Free androgen index will be calculated by the formula 100x Total testosteronSHBG
Serum CNP levels of the patients will be analyzed by an enzyme-linked immunosorbent ELISA assay for human C-type natriuretic peptide in accordance with the manufacturers instructions SEA721Hu ELISA Kit for Human C-Type Natriuretic Peptide Wuhan USCN Business Co Ltd Cloud-Clone Corp CCC USA
Data will be analyzed using Statistical Packege for Social Sciences software SPSS v15 SPSS Inc Chicago IL USA Independent t-test will be used to compare the parameters with normal distribution Parameters that dont fulfill the parametric test assumptions will be compared using Mann-Whitney U test Correlation of CNP with other parameters will be analyzed using Spearmans rank correlation test Receiver operating characteristic ROC curve will be used to evaluate diagnostic sensitivity and specificity of CNP for PCOS P values less than 005 will be regarded 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