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

• Sponsor: Near East University, Turkey (Other)
• Overall Status: Completed
• CT.gov ID: NCT04006171
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.6
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; c Type Natriuretic Peptide; Menstrual Irregularity; Hyperandrogenism	Diagnostic Test: C type natriuretic peptide	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: C Type Natriuretic Peptide and Polycystic Ovary Syndrome
• Actual Study Start Date: Jul 15, 2019
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: women with polycystic ovary syndrome 36 patients with PCOS	Diagnostic Test: C type natriuretic peptide; Serum level of CNP in PCOS and healthy women
Active Comparator: Healthy women of reproductive age 30 patients with regular normal menstrual cycle	Diagnostic Test: C type natriuretic peptide; Serum level of CNP in PCOS and healthy women

Outcome Measures

Primary Outcome Measures

1. Serum CNP Levels of PCOS and Healthy Participants [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 [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 Outcome Measures

1. Comparison of FSH and LH of PCOS and Healthy Women [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Second or Third Day of Menstruation-morning fasting]

    Serum Insulin Levels of Participants were compared

14. Homeostatic Model Assessment of Insulin Resistance of Participants [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Near East University Faculty of Medicine	Nicosia		Cyprus	99138

Sponsors and Collaborators

• Near East University, Turkey

Investigators

• Principal Investigator: Özay, Near East University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2021

More Information

Publications

• Hiradate Y, Hoshino Y, Tanemura K, Sato E. C-type natriuretic peptide inhibits porcine oocyte meiotic resumption. Zygote. 2014 Aug;22(3):372-7. doi: 10.1017/S0967199412000615. Epub 2013 Jan 18.
• Kawamura K, Cheng Y, Kawamura N, Takae S, Okada A, Kawagoe Y, Mulders S, Terada Y, Hsueh AJ. Pre-ovulatory LH/hCG surge decreases C-type natriuretic peptide secretion by ovarian granulosa cells to promote meiotic resumption of pre-ovulatory oocytes. Hum Reprod. 2011 Nov;26(11):3094-101. doi: 10.1093/humrep/der282. Epub 2011 Aug 23.
• Lee KB, Zhang M, Sugiura K, Wigglesworth K, Uliasz T, Jaffe LA, Eppig JJ. Hormonal coordination of natriuretic peptide type C and natriuretic peptide receptor 3 expression in mouse granulosa cells. Biol Reprod. 2013 Feb 21;88(2):42. doi: 10.1095/biolreprod.112.104810. Print 2013 Feb.
• Nogueira D, Albano C, Adriaenssens T, Cortvrindt R, Bourgain C, Devroey P, Smitz J. Human oocytes reversibly arrested in prophase I by phosphodiesterase type 3 inhibitor in vitro. Biol Reprod. 2003 Sep;69(3):1042-52. Epub 2003 May 28.
• Norris RP, Ratzan WJ, Freudzon M, Mehlmann LM, Krall J, Movsesian MA, Wang H, Ke H, Nikolaev VO, Jaffe LA. Cyclic GMP from the surrounding somatic cells regulates cyclic AMP and meiosis in the mouse oocyte. Development. 2009 Jun;136(11):1869-78. doi: 10.1242/dev.035238.
• Reis AM, Honorato-Sampaio K. C-type natriuretic peptide: a link between hyperandrogenism and anovulation in a mouse model of polycystic ovary syndrome. Clin Sci (Lond). 2018 May 8;132(9):905-908. doi: 10.1042/CS20171491. Print 2018 May 16.
• Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25.
• Thomas RE, Armstrong DT, Gilchrist RB. Differential effects of specific phosphodiesterase isoenzyme inhibitors on bovine oocyte meiotic maturation. Dev Biol. 2002 Apr 15;244(2):215-25.
• Tsafriri A, Chun SY, Zhang R, Hsueh AJ, Conti M. Oocyte maturation involves compartmentalization and opposing changes of cAMP levels in follicular somatic and germ cells: studies using selective phosphodiesterase inhibitors. Dev Biol. 1996 Sep 15;178(2):393-402.
• Vaccari S, Weeks JL 2nd, Hsieh M, Menniti FS, Conti M. Cyclic GMP signaling is involved in the luteinizing hormone-dependent meiotic maturation of mouse oocytes. Biol Reprod. 2009 Sep;81(3):595-604. doi: 10.1095/biolreprod.109.077768. Epub 2009 May 27.
• Wang X, Wang H, Liu W, Zhang Z, Zhang Y, Zhang W, Chen Z, Xia G, Wang C. High level of C-type natriuretic peptide induced by hyperandrogen-mediated anovulation in polycystic ovary syndrome mice. Clin Sci (Lond). 2018 Apr 6;132(7):759-776. doi: 10.1042/CS20171394. Print 2018 Apr 16.
• Zhang M, Su YQ, Sugiura K, Xia G, Eppig JJ. Granulosa cell ligand NPPC and its receptor NPR2 maintain meiotic arrest in mouse oocytes. Science. 2010 Oct 15;330(6002):366-9. doi: 10.1126/science.1193573.

• Responsible Party: Ali Cenk, Medical Doctor, assistant professor, Near East University, Turkey
• ClinicalTrials.gov Identifier: NCT04006171
• Other Study ID Numbers: CNP
• First Posted: Jul 5, 2019
• Last Update Posted: Nov 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ali Cenk, Medical Doctor, assistant professor, Near East University, Turkey: c type natriuretic peptide; polycystic ovary syndrome; menstrual cycle
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Hyperandrogenism; Syndrome; Menstruation Disturbances; Natriuretic Peptide, C-Type

Study Results

Participant Flow

Recruitment Details	The patients were recruited from Near East University Hospital, Department of Obstetrics and Gynecology.
Pre-assignment Detail	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, patients with hypertension hystory, history of ovarian surgery, current pregnancy, hyperprolactinemia, thyroid disease, congenital adrenal hyperplasia.

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Period Title: Overall Study
STARTED	48	42
COMPLETED	36	30
NOT COMPLETED	12	12

Baseline Characteristics

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age	Total
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	Total of all reporting groups
Overall Participants	36	30	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	36 100%	30 100%	66 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	22	24	23
Sex: Female, Male (Count of Participants)
Female	36 100%	30 100%	66 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Cypriot	36 100%	30 100%	66 100%
Region of Enrollment (participants) [Number]
Cyprus	36 100%	30 100%	66 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.20 (4.26)	21.17 (1.88)	22.28 (3.52)

Outcome Measures

1. Primary Outcome

Title	Serum CNP Levels of PCOS and Healthy Participants
Description	The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [pg/ml]	110	57

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Roc Curve of CNP
Description	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
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Participants
Arm/Group Description	all participants of the study
Measure Participants	66
Number (95% Confidence Interval) [probability]	0.706

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Roc curve
	Comments

3. Secondary Outcome

Title	Comparison of FSH and LH of PCOS and Healthy Women
Description	Serum FSH and LH of PCOS and healthy women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

FSH and LH should be evaluated during menstruation time period ( day 3)

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Follicle Stimulating Hormone	4.7	4.97
Luteinizing Hormone	4.23	5.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.171
	Comments	p value for FSH
	Method	Wilcoxon (Mann-Whitney)
	Comments	for FSH

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.176
	Comments	p value for LH
	Method	Wilcoxon (Mann-Whitney)
	Comments	for LH

4. Secondary Outcome

Title	Serum Estradiol Levels of PCOS and Healthy Women
Description	Serum Estradiol levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [pg/mL]	31	36.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.306
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Serum Tiroid Stimulating Hormone of PCOS and Healthy Women
Description	serum tiroid stimulating hormone of PCOS and healthy women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [mIU/L]	1.61	1.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.795
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

6. Secondary Outcome

Title	Serum Prolactin Levels of PCOS and Healthy Women
Description	serum prolactin levels of PCOS and healthy women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Mean (Standard Deviation) [ng/mL]	17.21 (6.65)	16.80 (6.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.852
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Serum Androstenedione Levels of PCOS and Healthy Women
Description	Serum Androstenedione Levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Mean (Standard Deviation) [ng/dL]	148.89 (52.38)	84.66 (11.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

8. Secondary Outcome

Title	Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women
Description	Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [µg/dL]	304.55	299.95

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.277
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

9. Secondary Outcome

Title	Serum Total Testosterone Levels of PCOS and Healthy Women
Description	Serum Total Testosterone Levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Mean (Standard Deviation) [nmol/L]	1.38 (0.48)	0.92 (0.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Serum Free Testosterone Levels of PCOS and Healthy Women
Description	Serum Free Testosterone Levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Mean (Standard Deviation) [pg/mL]	1.71 (0.64)	1.12 (0.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women
Description	Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [nmol/L]	30.4	59.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

12. Secondary Outcome

Title	Free Androgen Index of Participants
Description	Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin
Time Frame	Second or Third Day of Menstruation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Mean (Standard Deviation) [% of T testosterone per SHBG]	4.39 (2.58)	1.55 (0.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants
Description	Serum glucose, total cholesterol and triglycerides levels of participants were compared
Time Frame	Second or third day of menstruation and morning fasting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Total cholesterol	164	171
triglycerides	78	77
Glucose	88.5	89

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.947
	Comments	for serum glucose
	Method	Wilcoxon (Mann-Whitney)
	Comments	for serum glucose

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.906
	Comments	for total cholesterol
	Method	Wilcoxon (Mann-Whitney)
	Comments	for total cholesterol

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.428
	Comments	for triglycerides
	Method	Wilcoxon (Mann-Whitney)
	Comments	for triglycerides

14. Secondary Outcome

Title	High Density Lipoprotein and Low Density Lipoprotein Levels of Participants
Description	High density lipoprotein and low density lipoprotein levels of participants were compared
Time Frame	Second or Third Day of Menstruation-morning fasting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
High density lipoprotein	53.82 (11.06)	62.15 (19.48)
Low density lipoprotein	98.50 (23.61)	92.92 (23.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments	for high density lipoprotein
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.504
	Comments	for low density lipoprotein
	Method	Wilcoxon (Mann-Whitney)
	Comments	for low density lipoprotein

15. Secondary Outcome

Title	Serum Insulin Levels of Participants
Description	Serum Insulin Levels of Participants were compared
Time Frame	Second or Third Day of Menstruation-morning fasting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [mU/L]	7.10	7.10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.713
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

16. Secondary Outcome

Title	Homeostatic Model Assessment of Insulin Resistance of Participants
Description	homeostatic model assessment of insulin resistance of participants were compared. The calculation was made with formula Glucose X Insulin/405.
Time Frame	Second or Third Day of Menstruation-morning fasting

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Women With Polycystic Ovary Syndrome	Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women	30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
Measure Participants	36	30
Median (Inter-Quartile Range) [HOMA-IR Index]	1.50	1.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Women With Polycystic Ovary Syndrome, Healthy Women of Reproductive Age
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.886
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Adverse events were not assessed.
Adverse Event Reporting Description	Adverse events were not assessed.
Arm/Group Title	Women With Polycystic Ovary Syndrome		Healthy Women of Reproductive Age
Arm/Group Description	36 patients with PCOS C type natriuretic peptide: Serum level of CNP in PCOS and healthy women		30 patients with regular normal menstrual cycle C type natriuretic peptide: Serum level of CNP in PCOS and healthy women
All Cause Mortality
	Women With Polycystic Ovary Syndrome		Healthy Women of Reproductive Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Women With Polycystic Ovary Syndrome		Healthy Women of Reproductive Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Women With Polycystic Ovary Syndrome		Healthy Women of Reproductive Age
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The limitation of our study was the relatively small number of participants.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.