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NCT Number: NCT04006171

Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women

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.

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Key information

Conditions

Polycystic Ovary Syndrome 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Hyperandrogenism Male Urogenital Diseases Menstrual Irregularity Menstruation Disturbances Neoplasms Ovarian Cysts Ovarian Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Abnormalities Urogenital Diseases c Type Natriuretic Peptide

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C type natriuretic peptide

Diagnostic Test

Serum level of CNP in PCOS and healthy women

Primary outcomes

  1. Serum CNP Levels of PCOS and Healthy Participants

    Time frame: Second or Third Day of Menstruation

    The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women

  2. Roc Curve of CNP

    Time frame: Second or Third Day of Menstruation

    We made a cut off value estimation for the diagnosis of PCOS by serum CNP levels using Receiver operator characteristics. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. The higher the total area under the curve, the greater the predictive power of the CNP for diagnosing PCOS

Secondary outcomes

  1. Comparison of FSH and LH of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum FSH and LH of PCOS and healthy women were compared

  2. Serum Estradiol Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum Estradiol levels of PCOS and Healthy Women were compared

  3. Serum Tiroid Stimulating Hormone of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    serum tiroid stimulating hormone of PCOS and healthy women were compared

  4. Serum Prolactin Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    serum prolactin levels of PCOS and healthy women were compared

  5. Serum Androstenedione Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum Androstenedione Levels of PCOS and Healthy Women were compared

  6. Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared

  7. Serum Total Testosterone Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum Total Testosterone Levels of PCOS and Healthy Women were compared

  8. Serum Free Testosterone Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum Free Testosterone Levels of PCOS and Healthy Women were compared

  9. Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women

    Time frame: Second or Third Day of Menstruation

    Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared

  10. Free Androgen Index of Participants

    Time frame: Second or Third Day of Menstruation

    Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin

  11. Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants

    Time frame: Second or third day of menstruation and morning fasting

    Serum glucose, total cholesterol and triglycerides levels of participants were compared

  12. High Density Lipoprotein and Low Density Lipoprotein Levels of Participants

    Time frame: Second or Third Day of Menstruation-morning fasting

    High density lipoprotein and low density lipoprotein levels of participants were compared

  13. Serum Insulin Levels of Participants

    Time frame: Second or Third Day of Menstruation-morning fasting

    Serum Insulin Levels of Participants were compared

  14. Homeostatic Model Assessment of Insulin Resistance of Participants

    Time frame: Second or Third Day of Menstruation-morning fasting

    homeostatic model assessment of insulin resistance of participants were compared. The calculation was made with formula Glucose X Insulin/405.

Sponsors and collaborators

Lead sponsor

Near East University, Turkey

Other

Registry information

Official study title

C Type Natriuretic Peptide and Polycystic Ovary Syndrome

Acronym: CNP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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