Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women
Condition: Polycystic Ovary Syndrome; c Type Natriuretic Peptide; Menstrual Irregularity; Hyperandrogenism
MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome; Menstruation Disturbances
Study type: Interventional

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.
    

Intervention name(s): C type natriuretic peptide
Intervention type(s): Diagnostic Test
Intervention description(s): Serum level of CNP in PCOS and healthy women
Intervention MeSH terms: Natriuretic Peptide, C-Type
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: c type natriuretic peptide; polycystic ovary syndrome; menstrual cycle