Polycystic Ovary SyndromeCNPNCT04006171
Comparison of Serum C Type Natriuretic Peptide Levels Between Polycystic Ovary Syndrome Patients and Healthy Women
A study testing C type natriuretic peptide in people with Polycystic Ovary Syndrome and c Type Natriuretic Peptide, run by Near East University, Turkey at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, c Type Natriuretic Peptide, Menstrual Irregularity
- What is being tested?
- C type natriuretic peptide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 15 Jul 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- PCOS defined according to Rotterdam criteria
- Healthy normal menstruating women
Who cannot join
- Diabetes mellitus
- Cardiavascular disease
- Renal disease
- Any drug usage
- Smoking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C Type Natriuretic Peptide and Polycystic Ovary Syndrome
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.
- Conditions
- Polycystic Ovary Syndrome, c Type Natriuretic Peptide, Menstrual Irregularity, Hyperandrogenism
- Being tested
- C type natriuretic peptide
- Keywords
- c type natriuretic peptide, polycystic ovary syndrome, menstrual cycle
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C type natriuretic peptideDiagnostic test
Serum level of CNP in PCOS and healthy women
| Study group | Role | What they receive |
|---|---|---|
| women with polycystic ovary syndrome | Active comparator | 36 patients with PCOS Receives: Diagnostic Test: C type natriuretic peptide |
| Healthy women of reproductive age | Active comparator | 30 patients with regular normal menstrual cycle Receives: Diagnostic Test: C type natriuretic peptide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CNP Levels of PCOS and Healthy Participants
The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women
Measured: Second or Third Day of Menstruation
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
Measured: Second or Third Day of Menstruation
Secondary outcomes (14)
Comparison of FSH and LH of PCOS and Healthy Women
Serum FSH and LH of PCOS and healthy women were compared
Measured: Second or Third Day of Menstruation
Serum Estradiol Levels of PCOS and Healthy Women
Serum Estradiol levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Serum Tiroid Stimulating Hormone of PCOS and Healthy Women
serum tiroid stimulating hormone of PCOS and healthy women were compared
Measured: Second or Third Day of Menstruation
Serum Prolactin Levels of PCOS and Healthy Women
serum prolactin levels of PCOS and healthy women were compared
Measured: Second or Third Day of Menstruation
Serum Androstenedione Levels of PCOS and Healthy Women
Serum Androstenedione Levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women
Serum dehydroepiandrosterone sulfate (DHEAS) Levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Serum Total Testosterone Levels of PCOS and Healthy Women
Serum Total Testosterone Levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Serum Free Testosterone Levels of PCOS and Healthy Women
Serum Free Testosterone Levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women were compared
Measured: Second or Third Day of Menstruation
Free Androgen Index of Participants
Free androgen index of participants were compared. It was calculated with the formula 100XTotal testosterone/Sex hormone binding globulin
Measured: Second or Third Day of Menstruation
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants
Serum glucose, total cholesterol and triglycerides levels of participants were compared
Measured: Second or third day of menstruation and morning fasting
High Density Lipoprotein and Low Density Lipoprotein Levels of Participants
High density lipoprotein and low density lipoprotein levels of participants were compared
Measured: Second or Third Day of Menstruation-morning fasting
Serum Insulin Levels of Participants
Serum Insulin Levels of Participants were compared
Measured: Second or Third Day of Menstruation-morning fasting
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.
Measured: Second or Third Day of Menstruation-morning fasting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Cenk, Near East University, Turkey
- Investigators
- Özay, Principal investigator, Near East University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006171
- Sponsor's protocol ID
- CNP
- Acronym
- CNP
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2019
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 20947764Norris 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 19429786Vaccari 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 19474061Tsafriri 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 8812137Thomas 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 11944932Nogueira 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 12773402Lee 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 23255339Hiradate 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 23331536Kawamura 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 21865234Wang 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 29535265Reis 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 29739821Rotterdam 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 14711538Ozay AC, Ozay OE, Edebal OH. Role of C-type natriuretic peptide in polycystic ovary syndrome. Int J Gynaecol Obstet. 2023 May;161(2):601-606. doi: 10.1002/ijgo.14568. Epub 2022 Nov 25.
PubMed 36373234
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C Type Natriuretic Peptide and Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04006171
- Acronym / sponsor ID
- CNP / CNP
- Conditions
- Polycystic Ovary Syndrome, c Type Natriuretic Peptide, Menstrual Irregularity, Hyperandrogenism
- Keywords
- c type natriuretic peptide, polycystic ovary syndrome, menstrual cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with polycystic ovary syndrome | Active comparator | Diagnostic Test: C type natriuretic peptide36 patients with PCOS |
| Healthy women of reproductive age | Active comparator | Diagnostic Test: C type natriuretic peptide30 patients with regular normal menstrual cycle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PCOS defined according to Rotterdam criteria
- Healthy normal menstruating women
Key exclusion criteria (6 listed)
- Diabetes mellitus
- Cardiavascular disease
- Renal disease
- Any drug usage
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C type natriuretic peptideSerum level of CNP in PCOS and healthy women | Diagnostic test | Healthy women of reproductive age, women with polycystic ovary syndrome |
Primary outcome
Serum CNP Levels of PCOS and Healthy Participants
Time frame: Second or Third Day of Menstruation
The comparison of serum levels of C type natriuretic peptide among PCOS and healthy women
Roc Curve of CNP
Time frame: Second or Third Day of Menstruation
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
14 secondary outcomes
Comparison of FSH and LH of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Estradiol Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Tiroid Stimulating Hormone of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Prolactin Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Androstenedione Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Dehydroepiandrosterone Sulfate (DHEAS) Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Total Testosterone Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Free Testosterone Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Serum Sex Hormone Binding Globulin Levels of PCOS and Healthy Women
Time frame: Second or Third Day of Menstruation
Free Androgen Index of Participants
Time frame: Second or Third Day of Menstruation
Serum Glucose, Total Cholesterol and Triglycerides Levels of Participants
Time frame: Second or third day of menstruation and morning fasting
High Density Lipoprotein and Low Density Lipoprotein Levels of Participants
Time frame: Second or Third Day of Menstruation-morning fasting
Serum Insulin Levels of Participants
Time frame: Second or Third Day of Menstruation-morning fasting
Homeostatic Model Assessment of Insulin Resistance of Participants
Time frame: Second or Third Day of Menstruation-morning fasting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20947764Zhang 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.
- Background: PubMed 19429786Norris 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.
- Background: PubMed 19474061Vaccari 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.
- Background: PubMed 8812137Tsafriri 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.
- Background: PubMed 11944932Thomas 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.
- Background: PubMed 12773402Nogueira 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.
- Background: PubMed 23255339Lee 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.
- Background: PubMed 23331536Hiradate 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.
- Background: PubMed 21865234Kawamura 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.
- Background: PubMed 29535265Wang 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.
- Background: PubMed 29739821Reis 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.
- Background: PubMed 14711538Rotterdam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özay principal investigator
Near East University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C type natriuretic peptide in people with Polycystic Ovary Syndrome and c Type Natriuretic Peptide, run by Near East University, Turkey at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CNP Levels of PCOS and Healthy Participants (time frame: Second or Third Day of Menstruation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006171, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.