Viewing Study NCT04000815



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Last Modification Date: 2024-10-26 @ 1:12 PM
Study NCT ID: NCT04000815
Status: COMPLETED
Last Update Posted: 2020-03-11
First Post: 2019-06-22

Brief Title: Serum Levels of C Type Natriuretic Peptide in Different Reproductive Periods
Sponsor: Near East University Turkey
Organization: Near East University Turkey

Study Overview

Official Title: Serum Levels of C Type Natriuretic Peptide in Reproductive Age Perimenopausal and Postmenopausal Women
Status: COMPLETED
Status Verified Date: 2020-03
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: CO
Brief Summary: Recent studies have shown that C natriuretic peptide CNP is produced from granulosa cells increasing cumulative guanosine monophosphate cGMP production by affecting cumulus cells through natriuretic peptide receptorsIt has been suggested that the transport of cGMP to oocyte via gap junctions causes a continuous increase in cyclic adenosine monophosphate cAMP levels within the oocyte An important role of increased cAMP levels in oocyte is shown to suppress meiotic progression Deoxyribonucleic acid DNA 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 hormoneLH human chorionichCG stimulation Human studies have shown that after ovulation induction the CNP level in follicular fluid decreases following ovulatory dose of hCG 9
Detailed Description: In this prospective study 60 patients are planned to recruite Group 1 consists of 20 healthy reproductive aged women between 18-40 years old with regular menstruation Group 2 will include 20 patients in perimenopausal time period between 40-49 ages and in group 3 there will be20 postmenopausal women

Age gravida parity and body mass index BMI data of all patients will be recorded BMI is calculated by dividing the body weight in kilograms by the square of the height in meters All patients will go under ultrasound examination by the same clinician ACO The number of antral follicles in group 1 and group 2 will be recorded In addition on the 2nd or 3rd day of menstruation serum FSH LH and E2 data of the patients in group 1 and 2 will be recorded

For the last 6 months patients with drug use that may affect menstruation like oral contraceptives patients with cardiac or renal disease and therefore drug use causes of infertility other than unexplained infertility history of ovarian surgery presence of polycystic ovary syndrome and patients with irregular menstruation will be excluded for the study In addition patients with renal cardiac central nervous system and endocrine diseases will be excluded

Morning fasting venous blood samples will be taken from the patients on the 2nd or 3rd day of the menstruation for group 1 and 2 All blood samples will be centrifuged on the day of collection and separated serum samples and will be kept at -80 degrees until the day of CNP test Serum CNP levels of the patients will be analyzed by an enzyme-linked immunosorbent ELISA assay for human CNP in accordance with the manufacturers instructions SEA721Hu ELISA Kit for Human CNP Wuhan USCN Business Co Ltd Cloud-Clone Corp CCC USA

Data will be analyzed using Statistical Package for Social Sciences software SPSS v15 SPSS Inc Chicago IL USA The variables will be investigated using visual and analytical methods histograms homogeneity of variances test Kolmogorov-SimirnovShapiro-Wilks test to determine whether or not they are normally distributed Patient demographics and CNP values will be presented as median interquartile range Gravida and parity will be demonstrated by frequency distribution The correlation coefficients and their significance will be calculated using the Spearman test 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