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

NCT04006171 | Completed Results

• 1 other identifier: CNP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; c Type Natriuretic Peptide; Menstrual Irregularity; Hyperandrogenism

Keywords

c type natriuretic peptide; polycystic ovary syndrome; menstrual cycle

Outcome Measures

Primary Outcomes (2)

• Serum CNP Levels of PCOS and Healthy Participants

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

  Second or Third Day of Menstruation

• Roc Curve of CNP

  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

  Second or Third Day of Menstruation

Secondary Outcomes (14)

• Comparison of FSH and LH of PCOS and Healthy Women

  Second or Third Day of Menstruation

• Serum Estradiol Levels of PCOS and Healthy Women

  Second or Third Day of Menstruation

• Serum Tiroid Stimulating Hormone of PCOS and Healthy Women

  Second or Third Day of Menstruation

• Serum Prolactin Levels of PCOS and Healthy Women

  Second or Third Day of Menstruation

• Serum Androstenedione Levels of PCOS and Healthy Women

  Second or Third Day of Menstruation

Study Arms (2)

women with polycystic ovary syndrome

ACTIVE COMPARATOR

36 patients with PCOS

Diagnostic Test: C type natriuretic peptide

Healthy women of reproductive age

ACTIVE COMPARATOR

30 patients with regular normal menstrual cycle

Diagnostic Test: C type natriuretic peptide

Interventions

C type natriuretic peptide DIAGNOSTIC_TEST

Serum level of CNP in PCOS and healthy women

Healthy women of reproductive age; women with polycystic ovary syndrome

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

Location

Related Publications (13)

• 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.

  PMID: 20947764 BACKGROUND

• 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.

  PMID: 19429786 BACKGROUND

• 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.

  PMID: 19474061 BACKGROUND

• 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. doi: 10.1006/dbio.1996.0226.

  PMID: 8812137 BACKGROUND

• 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. doi: 10.1006/dbio.2002.0609.

  PMID: 11944932 BACKGROUND

• 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. doi: 10.1095/biolreprod.103.015982. Epub 2003 May 28.

  PMID: 12773402 BACKGROUND

• 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.

  PMID: 23255339 BACKGROUND

• 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.

  PMID: 23331536 BACKGROUND

• 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.

  PMID: 21865234 BACKGROUND

• 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.

  PMID: 29535265 BACKGROUND

• 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.

  PMID: 29739821 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2003.10.004.

  PMID: 14711538 BACKGROUND

• Ozay AC, Ozay OE, Edebal OH. Role of C-type natriuretic peptide in polycystic ovary syndrome. Int J Gynaecol Obstet. 2023 May;161(2):601-606. doi: 10.1002/ijgo.14568. Epub 2022 Nov 25.

  PMID: 36373234 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances; Hyperandrogenism

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

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

Results Point of Contact

• Title: Dr.Ali Cenk Ozay
• Organization: Near East University

dr.alicenk@hotmail.com

00905428583248

Study Officials

• Özay

  Near East University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, assistant professor

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 5, 2019
• Study Start: July 15, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 5, 2021
• Results First Posted: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)