Clinical trial NCT04006171: Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women
Official title: C Type Natriuretic Peptide and Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
c Type Natriuretic Peptide
Menstrual Irregularity
Hyperandrogenism
Keywords: c type natriuretic peptide
polycystic ovary syndrome
menstrual cycle
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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) stimulation.Human studies have shown that after ovulation induction, the CNP level in follicular fluid decreases following ovulatory dose of hCG.Polycystic 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 syndrome.CNP 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 1.5 mL Eppendorf (Eppendorf, Milano, Italy) tubes, and will be kept at -80°C until the day of CNP test. For the PCOS patients describing oligo/anovulation, 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 ¼ fasting blood glucose (mg/dL)fasting insulin (mIU/mL)/405. Free androgen index will be calculated by the formula 100x (Total testosteron/SHBG).

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 manufacturer's 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 don't fulfill the parametric test assumptions will be compared using Mann-Whitney U test. Correlation of CNP with other parameters will be analyzed using Spearman's 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 0.05 will be regarded as statistically significant.

Eligibility criteria: Inclusion Criteria:

* PCOS defined according to Rotterdam criteria
* Healthy normal menstruating women

Exclusion Criteria:

* Diabetes mellitus
* Cardiavascular disease
* Renal disease
* Any drug usage
* Smoking
* Pregnancy

Primary outcomes:
measure: Serum CNP Levels of PCOS and Healthy Participants
timeFrame: Second or Third Day of Menstruation
measure: Roc Curve of CNP
timeFrame: Second or Third Day of Menstruation
Secondary outcomes:
measure: Comparison of FSH and LH of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Estradiol Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Tiroid Stimulating Hormone of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Prolactin Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Androstenedione Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Total Testosterone Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Free Testosterone Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women
timeFrame: Second or Third Day of Menstruation
measure: Free Androgen Index of Participants
timeFrame: Second or Third Day of Menstruation
measure: Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants
timeFrame: Second or third day of menstruation and morning fasting
measure: High Density Lipoprotein and Low Density Lipoprotein Levels of Participants
timeFrame: Second or Third Day of Menstruation-morning fasting
measure: Serum Insulin Levels of Participants
timeFrame: Second or Third Day of Menstruation-morning fasting
measure: Homeostatic Model Assessment of Insulin Resistance of Participants
timeFrame: Second or Third Day of Menstruation-morning fasting
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University Faculty of Medicine
Study officials:
affiliation: Near East University
name: Özay
role: PRINCIPAL_INVESTIGATOR
References:
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