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CompletedNCT04006171CNPUpdated Nov 5, 2021Results posted

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

An interventional study of C type natriuretic peptide in Polycystic Ovary Syndrome, c Type Natriuretic Peptide and Menstrual Irregularity, sponsored by Near East University, Turkey. Completed at 1 site in Cyprus. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-05.

Sponsored by Near East University, Turkey · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

In this prospective study, a total of 60 patients are planed to be included. PCOS group will be consisted of 30 women and control group will include 30 healthy women with regular menstruation aged between 18-40 years old. PCOS diagnosis will be made according to Rotterdam criteria.

Age and body mass index of all participants will be recorded. BMI will be calculated by dividing weight by height in square meters. Then morning fasting venous blood samples will be taken from the patients between 2nd-5th day of menstruation for both groups. All blood samples will be centrifuged on the day of collection. Sera will be aliquoted into 1.5 mL Eppendorf (Eppendorf, Milano, Italy) tubes, and will be kept at -80°C until the day of CNP test. For the PCOS patients describing oligo/anovulation, after excluding pregnancy, progesterone withdrawal bleeding will be created and then the patients will be evaluated. Serum levels of LH, FSH, estradiol, thyroid stimulating hormone (TSH), prolactin (PRL), androstenedione, dehydroepiandrosterone sulfate (DHEAS), total testosterone, free testosterone, sex hormone binding globulin (SHBG), total cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), glucose and insulin levels will be analyzed. For insulin sensitivity, homeostatic model of insulin resistance (HOMA-IR) will be used and it will be calculated by the formula: HOMA-IR ¼ fasting blood glucose (mg/dL)fasting insulin (mIU/mL)/405. Free androgen index will be calculated by the formula 100x (Total testosteron/SHBG).

Serum CNP levels of the patients will be analyzed by an enzyme-linked immunosorbent (ELISA) assay for human C-type natriuretic peptide in accordance with the manufacturer's instructions (SEA721Hu, ELISA Kit for Human C-Type Natriuretic Peptide, Wuhan USCN Business Co., Ltd., Cloud-Clone Corp., CCC, USA).

Data will be analyzed using Statistical Packege for Social Sciences software (SPSS v15, SPSS Inc, Chicago, IL, USA). Independent t-test will be used to compare the parameters with normal distribution. Parameters that don't fulfill the parametric test assumptions will be compared using Mann-Whitney U test. Correlation of CNP with other parameters will be analyzed using Spearman's rank correlation test. Receiver operating characteristic (ROC) curve will be used to evaluate diagnostic sensitivity and specificity of CNP for PCOS. P values less than 0.05 will be regarded as statistically significant.

02

Conditions studied

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

Keywords

  • c type natriuretic peptide
  • polycystic ovary syndrome
  • menstrual cycle
03

In context

Polycystic Ovary Syndrome

956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.

This study's enrollment of 90 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Near East University, Turkey is the lead sponsor of 44 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diabetes mellitus
  • Cardiavascular disease
  • Renal disease
  • Any drug usage
  • Smoking
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    women with polycystic ovary syndrome

    36 patients with PCOS

    Diagnostic Test: C type natriuretic peptide

  • Active comparator
    Healthy women of reproductive age

    30 patients with regular normal menstrual cycle

    Diagnostic Test: C type natriuretic peptide

Interventions

  • Diagnostic testC type natriuretic peptide

    Serum level of CNP in PCOS and healthy women

06

What researchers measure

Primary outcomes

  1. Serum CNP Levels of PCOS and Healthy Participants

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

    Time frame: Second or Third Day of Menstruation

  2. 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

    Time frame: Second or Third Day of Menstruation

Secondary outcomes

  1. Comparison of FSH and LH of PCOS and Healthy Women

    Serum FSH and LH of PCOS and healthy women were compared

    Time frame: Second or Third Day of Menstruation

  2. Serum Estradiol Levels of PCOS and Healthy Women

    Serum Estradiol levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  3. Serum Tiroid Stimulating Hormone of PCOS and Healthy Women

    serum tiroid stimulating hormone of PCOS and healthy women were compared

    Time frame: Second or Third Day of Menstruation

  4. Serum Prolactin Levels of PCOS and Healthy Women

    serum prolactin levels of PCOS and healthy women were compared

    Time frame: Second or Third Day of Menstruation

  5. Serum Androstenedione Levels of PCOS and Healthy Women

    Serum Androstenedione Levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  6. Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women

    Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  7. Serum Total Testosterone Levels of PCOS and Healthy Women

    Serum Total Testosterone Levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  8. Serum Free Testosterone Levels of PCOS and Healthy Women

    Serum Free Testosterone Levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  9. Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women

    Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared

    Time frame: Second or Third Day of Menstruation

  10. Free Androgen Index of Participants

    Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin

    Time frame: Second or Third Day of Menstruation

  11. Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants

    Serum glucose, total cholesterol and triglycerides levels of participants were compared

    Time frame: Second or third day of menstruation and morning fasting

  12. High Density Lipoprotein and Low Density Lipoprotein Levels of Participants

    High density lipoprotein and low density lipoprotein levels of participants were compared

    Time frame: Second or Third Day of Menstruation-morning fasting

  13. Serum Insulin Levels of Participants

    Serum Insulin Levels of Participants were compared

    Time frame: Second or Third Day of Menstruation-morning fasting

  14. Homeostatic Model Assessment of Insulin Resistance of Participants

    homeostatic model assessment of insulin resistance of participants were compared. The calculation was made with formula Glucose X Insulin/405.

    Time frame: Second or Third Day of Menstruation-morning fasting

07

Results

Posted Nov 5, 2021
Limitations and caveats
The limitation of our study was the relatively small number of participants.

Participant flow

The patients were recruited from Near East University Hospital, Department of Obstetrics and Gynecology.

Participant flow — Overall Study
MilestoneWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Started4842
Completed3630
Not completed1212
Withdrew: Withdrawal by subject87
Withdrew: Missing serum samples22
Withdrew: Insufficient sample volume23

Outcome measures

PrimarySerum CNP Levels of PCOS and Healthy Participants

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

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · pg/ml
Serum CNP Levels of PCOS and Healthy Participants
pg/mlWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum CNP Levels of PCOS and Healthy Participants110 (90.9 to 182)57 (43.3 to 151.3)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.004
PrimaryRoc 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

Time frame:
Second or Third Day of Menstruation
Reported as:
Number · probability
Roc Curve of CNP
probabilityAll Participants
Roc Curve of CNP0.706 (0.574 to 0.838)
Statistical analysis
  • All Participants · Roc curve · p = 0.004
SecondaryComparison of FSH and LH of PCOS and Healthy Women

Serum FSH and LH of PCOS and healthy women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · mIU/mL
Comparison of FSH and LH of PCOS and Healthy Women
mIU/mLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Follicle Stimulating Hormone4.7 (3.95 to 5.7)4.97 (4.55 to 6.06)
Luteinizing Hormone4.23 (3.21 to 6.34)5.36 (3 to 6.89)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.171 (p value for FSH)for FSH
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.176 (p value for LH)for LH
SecondarySerum Estradiol Levels of PCOS and Healthy Women

Serum Estradiol levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · pg/mL
Serum Estradiol Levels of PCOS and Healthy Women
pg/mLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Estradiol Levels of PCOS and Healthy Women31 (23.5 to 45)36.5 (25 to 47.3)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.306
SecondarySerum Tiroid Stimulating Hormone of PCOS and Healthy Women

serum tiroid stimulating hormone of PCOS and healthy women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · mIU/L
Serum Tiroid Stimulating Hormone of PCOS and Healthy Women
mIU/LWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Tiroid Stimulating Hormone of PCOS and Healthy Women1.61 (1.14 to 2.15)1.47 (1.28 to 1.94)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.795
SecondarySerum Prolactin Levels of PCOS and Healthy Women

serum prolactin levels of PCOS and healthy women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Mean · ng/mL
Serum Prolactin Levels of PCOS and Healthy Women
ng/mLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Prolactin Levels of PCOS and Healthy Women17.21 ± 6.6516.80 ± 6.26
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = 0.852
SecondarySerum Androstenedione Levels of PCOS and Healthy Women

Serum Androstenedione Levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Mean · ng/dL
Serum Androstenedione Levels of PCOS and Healthy Women
ng/dLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Androstenedione Levels of PCOS and Healthy Women148.89 ± 52.3884.66 ± 11.56
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = <0.001
SecondarySerum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women

Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · µg/dL
Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women
µg/dLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women304.55 (224.85 to 411.20)299.95 (213.8 to 356.3)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.277
SecondarySerum Total Testosterone Levels of PCOS and Healthy Women

Serum Total Testosterone Levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Mean · nmol/L
Serum Total Testosterone Levels of PCOS and Healthy Women
nmol/LWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Total Testosterone Levels of PCOS and Healthy Women1.38 ± 0.480.92 ± 0.36
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = 0.006
SecondarySerum Free Testosterone Levels of PCOS and Healthy Women

Serum Free Testosterone Levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Mean · pg/mL
Serum Free Testosterone Levels of PCOS and Healthy Women
pg/mLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Free Testosterone Levels of PCOS and Healthy Women1.71 ± 0.641.12 ± 0.30
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = <0.001
SecondarySerum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women

Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared

Time frame:
Second or Third Day of Menstruation
Reported as:
Median · nmol/L
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women
nmol/LWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women30.4 (26.8 to 53.8)59.4 (46.6 to 78.1)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.014
SecondaryFree Androgen Index of Participants

Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin

Time frame:
Second or Third Day of Menstruation
Reported as:
Mean · % of T testosterone per SHBG
Free Androgen Index of Participants
% of T testosterone per SHBGWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Free Androgen Index of Participants4.39 ± 2.581.55 ± 0.89
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = <0.001
SecondarySerum Glucose, Total Cholesterol and Triglycerides Levels of Participants

Serum glucose, total cholesterol and triglycerides levels of participants were compared

Time frame:
Second or third day of menstruation and morning fasting
Reported as:
Median · mg/dL
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants
mg/dLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Total cholesterol164 (154.3 to 185)171 (146 to 189)
triglycerides78 (63.8 to 107.8)77 (60 to 90)
Glucose88.5 (83.3 to 97.8)89 (82.3 to 94.3)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.947 (for serum glucose)for serum glucose
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.906 (for total cholesterol)for total cholesterol
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.428 (for triglycerides)for triglycerides
SecondaryHigh Density Lipoprotein and Low Density Lipoprotein Levels of Participants

High density lipoprotein and low density lipoprotein levels of participants were compared

Time frame:
Second or Third Day of Menstruation-morning fasting
Reported as:
Mean · mg/dL
High Density Lipoprotein and Low Density Lipoprotein Levels of Participants
mg/dLWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
High density lipoprotein53.82 ± 11.0662.15 ± 19.48
Low density lipoprotein98.50 ± 23.6192.92 ± 23.56
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · t-test, 2 sided · p = 0.114 (for high density lipoprotein)
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.504 (for low density lipoprotein)for low density lipoprotein
SecondarySerum Insulin Levels of Participants

Serum Insulin Levels of Participants were compared

Time frame:
Second or Third Day of Menstruation-morning fasting
Reported as:
Median · mU/L
Serum Insulin Levels of Participants
mU/LWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Serum Insulin Levels of Participants7.10 (4.9 to 10)7.10 (5.75 to 8)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.713
SecondaryHomeostatic Model Assessment of Insulin Resistance of Participants

homeostatic model assessment of insulin resistance of participants were compared. The calculation was made with formula Glucose X Insulin/405.

Time frame:
Second or Third Day of Menstruation-morning fasting
Reported as:
Median · HOMA-IR Index
Homeostatic Model Assessment of Insulin Resistance of Participants
HOMA-IR IndexWomen With Polycystic Ovary SyndromeHealthy Women of Reproductive Age
Homeostatic Model Assessment of Insulin Resistance of Participants1.50 (1.05 to 2.15)1.45 (1.33 to 1.88)
Statistical analysis
  • Women With Polycystic Ovary Syndrome vs Healthy Women of Reproductive Age · Wilcoxon (Mann-Whitney) · p = 0.886

Adverse events

Collected over Adverse events were not assessed.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Women With Polycystic Ovary Syndrome———
Healthy Women of Reproductive Age———

Baseline characteristics

36 PCOS patient according to Rotterdam criterias and 30 healthy control women

Age, Categorical
Age, Categorical(Participants)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
<=18 years000
Between 18 and 65 years363066
>=65 years000
Age, Continuous
Age, Continuous(years)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
Median22 (21 to 24.8)24 (21.8 to 25)23 (21 to 25)
Sex: Female, Male
Sex: Female, Male(Participants)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
Female363066
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
Cypriot363066
Region of Enrollment
Region of Enrollment(participants)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
Cyprus363066
Body Mass Index
Body Mass Index(kg/m^2)Women With Polycystic Ovary SyndromeHealthy Women of Reproductive AgeTotal
Mean23.20 ± 4.2621.17 ± 1.8822.28 ± 3.52
08

Study locations

1 site
  • Near East University Faculty of Medicine
    Nicosia, 99138, Cyprus
09

References and documents

Publications

  • 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. PubMed 20947764 ↗
  • 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. PubMed 19429786 ↗
  • 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. PubMed 19474061 ↗
  • 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. PubMed 8812137 ↗
  • 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. PubMed 11944932 ↗
  • 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. PubMed 12773402 ↗
  • 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. PubMed 23255339 ↗
  • 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. PubMed 23331536 ↗
  • 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. PubMed 21865234 ↗
  • 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. PubMed 29535265 ↗
  • 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. PubMed 29739821 ↗
  • 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. PubMed 14711538 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04006171
Lead sponsor
Near East University, Turkey
Responsible party
Ali Cenk (Medical Doctor, assistant professor, Near East University, Turkey) — Principal investigator
First posted
Jul 5, 2019
Start date
Jul 15, 2019
Primary completion
Sep 1, 2020
Completion
Sep 1, 2020
Results posted
Nov 5, 2021
Last update
Nov 5, 2021

Study contacts

Özay
principal investigator · Near East University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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