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Serum Levels of C Type Natriuretic Peptide in Different Reproductive Periods

Serum Levels of C Type Natriuretic Peptide in Reproductive Age, Perimenopausal and Postmenopausal Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04000815
Acronym
CO
Enrollment
71
Registered
2019-06-27
Start date
2019-07-24
Completion date
2020-01-20
Last updated
2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Perimenopausal Women, Healthy Postmenopausal Women, Healthy Reproductive Age Women, Serum CNP Levels

Keywords

c type natriuretic peptide, duration of menopause, menstrual cycle

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).

Detailed description

In this prospective study, 60 patients are planned to recruite. Group 1 consists of 20 healthy reproductive aged women between 18-40 years old, with regular menstruation. Group 2 will include 20 patients in perimenopausal time period between 40-49 ages and in group 3 there will be20 postmenopausal women. Age, gravida, parity and body mass index (BMI) data of all patients will be recorded. BMI is calculated by dividing the body weight in kilograms by the square of the height in meters. All patients will go under ultrasound examination by the same clinician (ACO). The number of antral follicles in group 1 and group 2 will be recorded. In addition, on the 2nd or 3rd day of menstruation, serum FSH, LH and E2 data of the patients in group 1 and 2 will be recorded. 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, causes of infertility other than unexplained infertility, history of ovarian surgery, presence of polycystic ovary syndrome, and patients with irregular menstruation will be excluded for the study. In addition, patients with renal, cardiac, central nervous system and endocrine diseases will be excluded. Morning fasting venous blood samples will be taken from the patients on the 2nd or 3rd day of the menstruation for group 1 and 2. All blood samples will be centrifuged on the day of collection and separated serum samples and will be kept at -80 degrees until the day of CNP test. Serum CNP levels of the patients will be analyzed by an enzyme-linked immunosorbent (ELISA) assay for human CNP in accordance with the manufacturer's instructions (SEA721Hu, ELISA Kit for Human CNP, Wuhan USCN Business Co., Ltd., Cloud-Clone Corp., CCC, USA). Data will be analyzed using Statistical Package for Social Sciences software (SPSS v15, SPSS Inc, Chicago, IL, USA). The variables will be investigated using visual and analytical methods (histograms, homogeneity of variances test, Kolmogorov-Simirnov/Shapiro-Wilk's test) to determine whether or not they are normally distributed. Patient demographics and CNP values will be presented as median ± interquartile range. Gravida and parity will be demonstrated by frequency distribution. The correlation coefficients and their significance will be calculated using the Spearman test. P-values less than 0.05 will be regarded as statistically significant.

Interventions

DIAGNOSTIC_TESTC Type Natriüretic Peptide

C Type Natriuretic Peptide will be measured with elisa method

Sponsors

Near East University, Turkey
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy * Regular cyclic menstruation for reproductive age group

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Serum C Type Natriuretic Peptide LevelsSecond or Third Day of MenstruationThe comparison of serum levels of C type natriuretic peptide among different age groups

Secondary

MeasureTime frameDescription
Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2Second or Third Day of MenstruationCorrelations between serum CNP vs Follicle Stimulating Hormone(FSH), CNP vs Luteinizing Hormone(LH) levels in groups 1 and 2
Correlation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 2Second or Third Day of MenstruationCorrelation between serum CNP and antral follicle count (AFC) in groups 1 and 2 using Spearman test
Correlation Between Serum CNP and Estradiol Levels in Groups 1 and 2Second or Third Day of MenstruationCorrelation of CNP vs. Estradiol levels in reproductive age and perimenopausal women

Countries

Cyprus

Participant flow

Pre-assignment details

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, causes of infertility other than unexplained infertility, history of ovarian surgery, presence of polycystic ovary syndrome, and patients with irregular menstruation.

Participants by arm

ArmCount
Reproductive Age Women
The healthy women between 18-40 years old. C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method
15
Perimenopausal Women
The healthy women between 40-49 years old. C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method
15
Postmenopausal Women
The healthy women that has been in to menopause more than a year C Type Natriüretic Peptide: C Type Natriuretic Peptide will be measured with elisa method
15
Total45

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyHypertension occured on follow up002
Overall StudyLost to Follow-up923
Overall StudyRight ovarian cyst occured100
Overall StudyWithdrawal by Subject432

Baseline characteristics

CharacteristicReproductive Age WomenPerimenopausal WomenPostmenopausal WomenTotal
Age, Continuous24.9 years
STANDARD_DEVIATION 2.9
44.1 years
STANDARD_DEVIATION 2.2
57.7 years
STANDARD_DEVIATION 5.4
42.2 years
STANDARD_DEVIATION 14.1
BMI21.3 kg/m^2
STANDARD_DEVIATION 1.9
24.3 kg/m^2
STANDARD_DEVIATION 2.4
27.1 kg/m^2
STANDARD_DEVIATION 4.1
24.2 kg/m^2
STANDARD_DEVIATION 3.8
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Cyprus
15 Participants15 Participants15 Participants45 Participants
Sex: Female, Male
Female
15 Participants15 Participants15 Participants45 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Serum C Type Natriuretic Peptide Levels

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

Time frame: Second or Third Day of Menstruation

ArmMeasureValue (MEDIAN)
Reproductive Age WomenSerum C Type Natriuretic Peptide Levels43.68 pg/ml
Perimenopausal WomenSerum C Type Natriuretic Peptide Levels55.98 pg/ml
Postmenopausal WomenSerum C Type Natriuretic Peptide Levels116.36 pg/ml
p-value: <0.017Kruskal-Wallis
Secondary

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

Correlation between serum CNP and antral follicle count (AFC) in groups 1 and 2 using Spearman test

Time frame: Second or Third Day of Menstruation

Population: AFC should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate AFC value since they do not have menstruation. Therefore in postmenopausal arm group AFC value is not studied.

ArmMeasureValue (MEAN)Dispersion
Reproductive Age WomenCorrelation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 214.2 folliclesStandard Deviation 2.18
Perimenopausal WomenCorrelation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 28.33 folliclesStandard Deviation 1.72
p-value: <0.05Bi-variate correlation
Secondary

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

Correlation of CNP vs. Estradiol levels in reproductive age and perimenopausal women

Time frame: Second or Third Day of Menstruation

Population: Estradiol should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate this hormone since they do not have menstruation. Therefore in postmenopausal arm group this hormone is not studied.

ArmMeasureValue (MEDIAN)
Reproductive Age WomenCorrelation Between Serum CNP and Estradiol Levels in Groups 1 and 241 pg/mL
Perimenopausal WomenCorrelation Between Serum CNP and Estradiol Levels in Groups 1 and 222 pg/mL
p-value: <0.05Bi-variate correlation analyses
Secondary

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

Correlations between serum CNP vs Follicle Stimulating Hormone(FSH), CNP vs Luteinizing Hormone(LH) levels in groups 1 and 2

Time frame: Second or Third Day of Menstruation

Population: FSH and LH should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate these hormones since they do not have menstruation. Therefore in postmenopausal arm group these hormones (FSH and LH) are not studied.

ArmMeasureGroupValue (MEDIAN)
Reproductive Age WomenCorrelation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2Follicle Stimulating Hormone5.28 mIU/mL
Reproductive Age WomenCorrelation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2Luteinizing Hormone5.71 mIU/mL
Perimenopausal WomenCorrelation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2Follicle Stimulating Hormone13.12 mIU/mL
Perimenopausal WomenCorrelation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2Luteinizing Hormone5.16 mIU/mL
p-value: <0.05Bi-variate correlation analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026