NCT04000815

Brief Summary

Recent studies have shown that C natriuretic peptide (CNP) is produced from granulosa cells, increasing cumulative guanosine monophosphate (cGMP) production by affecting cumulus cells through natriuretic peptide receptors.It has been suggested that the transport of cGMP to oocyte via gap junctions causes a continuous increase in cyclic adenosine monophosphate (cAMP) levels within the oocyte. An important role of increased cAMP levels in oocyte is shown to suppress meiotic progression. Deoxyribonucleic acid (DNA) 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(LH) / human chorionic(hCG) stimulation. Human studies have shown that after ovulation induction, the CNP level in follicular fluid decreases following ovulatory dose of hCG (9).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

July 24, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 11, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

June 22, 2019

Results QC Date

January 24, 2020

Last Update Submit

March 9, 2020

Conditions

Keywords

c type natriuretic peptideduration of menopausemenstrual cycle

Outcome Measures

Primary Outcomes (1)

  • Serum C Type Natriuretic Peptide Levels

    The comparison of serum levels of C type natriuretic peptide among different age groups

    Second or Third Day of Menstruation

Secondary Outcomes (3)

  • Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2

    Second or Third Day of Menstruation

  • Correlation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 2

    Second or Third Day of Menstruation

  • Correlation Between Serum CNP and Estradiol Levels in Groups 1 and 2

    Second or Third Day of Menstruation

Study Arms (3)

Reproductive age women

ACTIVE COMPARATOR

The healthy women between 18-40 years old.

Diagnostic Test: C Type Natriüretic Peptide

Perimenopausal women

ACTIVE COMPARATOR

The healthy women between 40-49 years old.

Diagnostic Test: C Type Natriüretic Peptide

Postmenopausal women

ACTIVE COMPARATOR

The healthy women that has been in to menopause more than a year

Diagnostic Test: C Type Natriüretic Peptide

Interventions

C Type Natriuretic Peptide will be measured with elisa method

Perimenopausal womenPostmenopausal womenReproductive age women

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants will be included
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy
  • Regular cyclic menstruation for reproductive age group

You may not qualify if:

  • No systemic disease(cardiac, renal...etc)
  • Smoking
  • Drug usage
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University Faculty of Medicine

Nicosia, 99138, Cyprus

Location

Related Publications (9)

  • 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: 20947764BACKGROUND
  • 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: 19429786BACKGROUND
  • 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: 19474061BACKGROUND
  • 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: 8812137BACKGROUND
  • 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: 11944932BACKGROUND
  • 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: 12773402BACKGROUND
  • 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: 23255339BACKGROUND
  • 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: 23331536BACKGROUND
  • 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: 21865234BACKGROUND

Limitations and Caveats

The most prominent limitation of our study was the relatively small number of participants. This avoided us from using more powerful parametric tests for statistical analysis.

Results Point of Contact

Title
Dr.Ali Cenk Ozay
Organization
Dr.Ali Cenk Ozay

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
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: In this study, there are three groups. Group 1:Women between 18-40 age, Group 2:Perimenopausal women (40-49 years), Group 3: Postmenopausal women.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 22, 2019

First Posted

June 27, 2019

Study Start

July 24, 2019

Primary Completion

January 9, 2020

Study Completion

January 20, 2020

Last Updated

March 11, 2020

Results First Posted

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Only the name of study

Locations