Healthy Perimenopausal Women, Healthy Postmenopausal Women, Healthy Reproductive Age Women, Serum CNP Levels
Conditions
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
C Type Natriuretic Peptide will be measured with elisa method
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Serum C Type Natriuretic Peptide Levels | Second or Third Day of Menstruation | The comparison of serum levels of C type natriuretic peptide among different age groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2 | Second or Third Day of Menstruation | Correlations 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 2 | Second or Third Day of Menstruation | Correlation 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 2 | Second or Third Day of Menstruation | Correlation 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
| Arm | Count |
|---|---|
| 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 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Hypertension occured on follow up | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 9 | 2 | 3 |
| Overall Study | Right ovarian cyst occured | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | Reproductive Age Women | Perimenopausal Women | Postmenopausal Women | Total |
|---|---|---|---|---|
| Age, Continuous | 24.9 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 |
| BMI | 21.3 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 Collected | — | — | — | 0 Participants |
| Region of Enrollment Cyprus | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 15 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reproductive Age Women | Serum C Type Natriuretic Peptide Levels | 43.68 pg/ml |
| Perimenopausal Women | Serum C Type Natriuretic Peptide Levels | 55.98 pg/ml |
| Postmenopausal Women | Serum C Type Natriuretic Peptide Levels | 116.36 pg/ml |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reproductive Age Women | Correlation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 2 | 14.2 follicles | Standard Deviation 2.18 |
| Perimenopausal Women | Correlation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 2 | 8.33 follicles | Standard Deviation 1.72 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reproductive Age Women | Correlation Between Serum CNP and Estradiol Levels in Groups 1 and 2 | 41 pg/mL |
| Perimenopausal Women | Correlation Between Serum CNP and Estradiol Levels in Groups 1 and 2 | 22 pg/mL |
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Reproductive Age Women | Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2 | Follicle Stimulating Hormone | 5.28 mIU/mL |
| Reproductive Age Women | Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2 | Luteinizing Hormone | 5.71 mIU/mL |
| Perimenopausal Women | Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2 | Follicle Stimulating Hormone | 13.12 mIU/mL |
| Perimenopausal Women | Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2 | Luteinizing Hormone | 5.16 mIU/mL |