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Trial record 64 of 107 for:    "21-hydroxylase deficiency"

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

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ClinicalTrials.gov Identifier: NCT04006171
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ali Cenk, Near East University, Turkey

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019


Arm Intervention/treatment
Active Comparator: women with polycystic ovary syndrome
30 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




Primary Outcome Measures :
  1. CNP and PCOS [ Time Frame: two months ]
    Serum CNP levels of PCOS patients

  2. CNP and Healthy women [ Time Frame: two months ]
    Serum CNP levels of normal menstruating healthy women


Secondary Outcome Measures :
  1. Compare CNP [ Time Frame: Two months ]
    Comparison of CNP levels in PCOS and healthy women



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006171


Contacts
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Contact: Ali C Özay, MD 00903926751000 ext 1341 dr.alicenk@hotmail.com
Contact: Özlen Emekçi Özay, MD 00903926751000 ext 1349 ozlenemekci@yahoo.com

Locations
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Cyprus
Near East University Faculty of Medicine
Nicosia, Cyprus, 99138
Sponsors and Collaborators
Near East University, Turkey
Investigators
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Principal Investigator: Özay Near East University

Publications of Results:

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Responsible Party: Ali Cenk, Medical Doctor, assistant professor, Near East University, Turkey
ClinicalTrials.gov Identifier: NCT04006171     History of Changes
Other Study ID Numbers: CNP
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Cenk, Near East University, Turkey:
c type natriuretic peptide
polycystic ovary syndrome
menstrual cycle
Additional relevant MeSH terms:
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Adrenogenital Syndrome
Polycystic Ovary Syndrome
Hyperandrogenism
Syndrome
Menstruation Disturbances
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Natriuretic Peptide, C-Type
Natriuretic Agents
Physiological Effects of Drugs