Polycystic Ovary SyndromeNCT04104958
IVF Outcome in Polycystic Ovary Syndrome Patients
An observational study of Polycystic Ovary Syndrome, run by Assiut University.
Trial summary
1. To investigate the circulating concentrations of phoenixin and their associations with BMI, the concentrations of sex hormones including (LH), (FSH), (E2), (P4), (TT) and steroid hormones enzyme in PCOS patients. 2. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- qRTPCR (mRNA level).
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Adult
Study population: PCOS who are diagnosed according to the criteria of the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2003), which require two of the following 3 manifestations: 1. oligo- or anovulation, 2. clinical and/or biochemical signs of hyperandrogenism (> 2.08 nmol/l), 3. polycystic ovaries on ultrasound examination (the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume > 10 cm)
Who may be able to join
- • The diagnosis included donors, male factor infertility and PCOS women.
- Age ranging from 20 to 40 years
Who cannot join
- • There were no other etiologies for the PCOS cases, such as congenital adrenal hyperplasia, 21-hydroxylase deficiency, androgen-secreting tumors, Cushing's syndrome, thyroid disease, and hyperprolactinemia.
- Patients with endometriosis.
- Patients with history of coronary artery disease, hypertension, liver cirrhosis or hematologic disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Identification of Recent Biomarkers in Polycystic Ovary Syndrome Patients as a Predictors of IVF Outcome
- To investigate the circulating concentrations of phoenixin and their associations with BMI, the concentrations of sex hormones including (LH), (FSH), (E2), (P4), (TT) and steroid hormones enzyme in PCOS patients.
- To detect the expression PNX and humanin in women with or without PCOS and to elucidate possible correlations with ovarian reserve and clinical outcomes after IVF-ICSI.
- To investigate relationship between PNX, humanin expression and PI3K/AKT/mTOR and autophagy pathway as a major signaling mechanism in PCOS for targeting new prognostic and therapeutic markers.
- The study investigates the correlation between oocyte maturity, fertilization, recent biomarkers and a variety of hormonal parameters in follicular fluid.
Read the detailed description
- In vitro fertilization (IVF) is an important tool for those couples with difficulty conceiving or maintaining a pregnancy. In the United States, infants conceived with IVF account for approximately 1.6% of live births.
- Polycystic ovary syndrome (PCOS), a highly prevalent gynecological disease, is often characterized by amenorrhea, hirsutism, polycystic ovaries on ultrasound scan, elevated serum luteinizing hormone (LH), low serum follicle-stimulating hormone (FSH), anovulatory infertility, pregnancy and neonatal complications; it is also an important cause of infertility in women of reproductive age because of the associated anovulation. IVF are commonly used for PCOS-associated infertility, there are still some questions regarding the paucity of high quality oocyte, low fertilization, and final pregnancy rate in women with PCOS following IVF.
- Depending on the particular criteria used for diagnosis and the population studied, the prevalence of PCOS has been reported to range from 8% to 13% in women of childbearing age women worldwide.
- Phoenixin was recently discovered using a bioinformatics algorithm which utilized information provided by the Human Genome Project A recently discovered hypothalamic neuropeptide phoenixin is involved in the regulation of the reproductive system, anxiety-related behaviors and pain. Phoenixin acts through its receptor, G protein-coupled receptor 173 (GPR173), to activate the cAMP/PKA pathway leading to the phosphorylation of CREB (pCREB).
- The expression of PNX and GPR173 in HGrC1 by RTPCR and Western blotting. Immunohistochemistry revealed that PNX and GPR173 are present in oocytes, granulosa cells and theca cells at different stages of follicular development in human ovary. GPR173 expression in theca cells increased according to follicle development. Treatment of HGrC1 cells with PNX-14 resulted in a significant upregulation of steroidogenesis enzymes: steroidogenic acute regulatory protein, side-chain cleavage enzyme, aromatase, 3β-HSD, and 17α-OH.These results suggest that PNX expressed in human follicles is possibly involved in folliculogenesis and steroidogenesis.
- In the heart, phoenixin has been shown to decrease myocardial apoptosis by enhancing the expression of the anti-apoptotic factor, Bcl-2 and reducing proapoptotic factors such as Bax, Caspase 3, Cytochrome C and p38 MAPK. Also, these cascades are activated in hearts exposed to PNX during the early reperfusion. Using selective inhibitors of specific targets of cardio protection, such as PI3K and by performing WB analysis of phosphorylated proteins of upstream Akt,, we revealed the involvement of this cascade in PNX-dependent cardio protection. Phoenixin might have induced proliferation in part by reducing apoptosis in GCs via the same mechanism.
- Activation of the phosphatidylinositol 3-kinase (PI3K)/Akt pathway protects against PCOS, which is attributed to prevention of cell apoptosis, facilitation of cell proliferation, induction or prevention of cell autophagy, alleviation of oxidative damage, and adaptation of hypoxia microenvironment.
- PNX may be associated with risk of developing PCOS. They proposed that PNX may provide a connection between multiple pathways contributing to PCOS including androgen action, insulin axis and apoptosis. PNX can serve as a new potential therapeutic target for PCOS patients undergo IVF and improved IVF outcome.
- Humanin is a small neuroprotective peptide identified from cDNA library of AD patient. Since its discovery, humanin has been shown to regulate many biological processes such as apoptosis, cell survival, metabolism, inflammation and oxidative stress. Published evidence suggests that humanin is secreted and expressed in many tissues, including the brain, retinal pigment epithelium, blood vessels, pancreatic beta cell, tumors and testes.
- Published evidence demonstrated the localization and distribution of humanin in human ovarian cells. Strong humanin expression was found in the ovary in multiple types of cells, including granulosa cells, oocytes and stromal cells. Further study revealed that follicular fluid humanin levels were correlated with ovarian reserve markers, and were associated with clinical pregnancy for women undergoing IVF-ICSI.
- Humanin is considered to exert a protective effect against apoptosis and oxidative stress. In preeclampsia, the rate of apoptosis was found to be increased, as a result of the oxidative stress that occurs in placenta.
- It is reported that abnormal insulin signaling is correlated with PCOS (11). IRS-1 is a key factor in insulin signaling pathway which has no kinase activity but its activity is regulated by phosphorylation/dephosphorylation. Serine phosphorylation,of IRS-1 would inhibit IRS-1 activity and block the activation of downstream signaling factors, leading to insulin resistance.
- There were no published data concerning humanin concentrations in pregnancy, especially in PCOS. Our study is the first to provide some expectations for such an association, demonstrating that humanin concentrations are increased in women with PCOS compared to controls.
- Autophagy is a lysosome mediated cellular process to clear misfolded protein, old or damaged organelle in the eukaryotes. Autophagy is an important mechanism to maintain cellular homeostasis and prevent tissue necrosis. Decreased expression of autophagy is associated with poor development of embryo and implantation failure. Moreover, Autophagy is physiologically involved in early normal gestation.
- mTOR is the crosstalk mediator between insulin signaling pathway and autophagy regulation. Insulin sensitivity is positively correlated with autophagy activity in pancreatic β cells, and insulin resistance is a common risk factor for both PCOS and type II diabetes.
- The present study demonstrate that humanin could regulate insulin signaling through IRS-1/mTOR in the hippocampus of APP/SP1 transgenic mice, decrease insulin resistance, improve autophagy in the neuron, decrease Aβ deposition and plaque formation, and improve learning ability and memory. These findings suggest that brain insulin signaling pathway, especially IRS-1/mTOR may be involved in autophagy regulation.
- Humanin treatment could enhance autophagy initiation and autophagy flux and decrease the accumulation of autophagosome to alleviate autophagy malfunction and improved IVF outcome in PCOS patients.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- qRTPCR (mRNA level).
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qRTPCR (mRNA level).Genetic
Also called ELISA, western blot analysis
RNA extraction and RT-qPCR Protein extraction and western blotting ELISA assay
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 (n=50): women (age 20-40year) with PCOS who are diagnosed according to the criteria of the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2003), which require two of the following 3 manifestations:
1. oligo- or anovulation,
2. clinical and/or biochemical signs of hyperandrogenism (> 2.08 nmol/l),
3. polycystic ovaries on ultrasound examination (the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume > 10 cm) Receives: Genetic: qRTPCR (mRNA level). | |
| Group 2 | Group 2 (n=50): women (age 20-40 year) with male factor infertility. Receives: Genetic: qRTPCR (mRNA level). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect difference in expression of phoenixin and humanin in PCOS
Detect difference in expression of phoenixin and humanin markers in follicular fluid and their role in pathogenesis of PCOS.
Measured: Baseline
Assess the link between phoenixin and humanin through the PI3/AKT/mTOR
Assess the link between phoenixin and humanin through the PI3/AKT/mTOR and autophagy signalling pathway that may be considered as a future therapeutic target in PCOS patients to improve IVF outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Mohamed Fikry, Assiut University
- Investigators
- Madiha Mahros Zakhary farag, Professor, Principal investigator, Faculty of medicin Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104958
- Sponsor's protocol ID
- PCOS IVF
- Status last verified
- Jan 2020
- First submitted
- 24 Sep 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rao M, Zhou F, Tang L, Zeng Z, Hu S, Wang Y, Ke D, Cheng G, Xia W, Zhang L, Zhu C. Follicular fluid humanin concentration is related to ovarian reserve markers and clinical pregnancy after IVF-ICSI: a pilot study. Reprod Biomed Online. 2019 Jan;38(1):108-117. doi: 10.1016/j.rbmo.2018.11.002. Epub 2018 Nov 23.
PubMed 30503199Nguyen XP, Nakamura T, Osuka S, Bayasula B, Nakanishi N, Kasahara Y, Muraoka A, Hayashi S, Nagai T, Murase T, Goto M, Iwase A, Kikkawa F. Effect of the neuropeptide phoenixin and its receptor GPR173 during folliculogenesis. Reproduction. 2019 Jul;158(1):25-34. doi: 10.1530/REP-19-0025.
PubMed 30933929Avagliano L, Terraneo L, Virgili E, Martinelli C, Doi P, Samaja M, Bulfamante GP, Marconi AM. Autophagy in Normal and Abnormal Early Human Pregnancies. Reprod Sci. 2015 Jul;22(7):838-44. doi: 10.1177/1933719114565036. Epub 2014 Dec 28.
PubMed 25544676Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.
PubMed 27664216
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Recent Biomarkers in Polycystic Ovary Syndrome Patients as a Predictors of IVF Outcome
- ClinicalTrials.gov ID
- NCT04104958
- Acronym / sponsor ID
- PCOS IVF
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To investigate the circulating concentrations of phoenixin and their associations with BMI, the concentrations of sex hormones including (LH), (FSH), (E2), (P4), (TT) and steroid hormones enzyme in PCOS patients.
- To detect the expression PNX and humanin in women with or without PCOS and to elucidate possible correlations with ovarian reserve and clinical outcomes after IVF-ICSI.
- To investigate relationship between PNX, humanin expression and PI3K/AKT/mTOR and autophagy pathway as a major signaling mechanism in PCOS for targeting new prognostic and therapeutic markers.
- The study investigates the correlation between oocyte maturity, fertilization, recent biomarkers and a variety of hormonal parameters in follicular fluid.
Detailed description
- In vitro fertilization (IVF) is an important tool for those couples with difficulty conceiving or maintaining a pregnancy. In the United States, infants conceived with IVF account for approximately 1.6% of live births.
- Polycystic ovary syndrome (PCOS), a highly prevalent gynecological disease, is often characterized by amenorrhea, hirsutism, polycystic ovaries on ultrasound scan, elevated serum luteinizing hormone (LH), low serum follicle-stimulating hormone (FSH), anovulatory infertility, pregnancy and neonatal complications; it is also an important cause of infertility in women of reproductive age because of the associated anovulation. IVF are commonly used for PCOS-associated infertility, there are still some questions regarding the paucity of high quality oocyte, low fertilization, and final pregnancy rate in women with PCOS following IVF.
- Depending on the particular criteria used for diagnosis and the population studied, the prevalence of PCOS has been reported to range from 8% to 13% in women of childbearing age women worldwide.
- Phoenixin was recently discovered using a bioinformatics algorithm which utilized information provided by the Human Genome Project A recently discovered hypothalamic neuropeptide phoenixin is involved in the regulation of the reproductive system, anxiety-related behaviors and pain. Phoenixin acts through its receptor, G protein-coupled receptor 173 (GPR173), to activate the cAMP/PKA pathway leading to the phosphorylation of CREB (pCREB).
- The expression of PNX and GPR173 in HGrC1 by RTPCR and Western blotting. Immunohistochemistry revealed that PNX and GPR173 are present in oocytes, granulosa cells and theca cells at different stages of follicular development in human ovary. GPR173 expression in theca cells increased according to follicle development. Treatment of HGrC1 cells with PNX-14 resulted in a significant upregulation of steroidogenesis enzymes: steroidogenic acute regulatory protein, side-chain cleavage enzyme, aromatase, 3β-HSD, and 17α-OH.These results suggest that PNX expressed in human follicles is possibly involved in folliculogenesis and steroidogenesis.
- In the heart, phoenixin has been shown to decrease myocardial apoptosis by enhancing the expression of the anti-apoptotic factor, Bcl-2 and reducing proapoptotic factors such as Bax, Caspase 3, Cytochrome C and p38 MAPK. Also, these cascades are activated in hearts exposed to PNX during the early reperfusion. Using selective inhibitors of specific targets of cardio protection, such as PI3K and by performing WB analysis of phosphorylated proteins of upstream Akt,, we revealed the involvement of this cascade in PNX-dependent cardio protection. Phoenixin might have induced proliferation in part by reducing apoptosis in GCs via the same mechanism.
- Activation of the phosphatidylinositol 3-kinase (PI3K)/Akt pathway protects against PCOS, which is attributed to prevention of cell apoptosis, facilitation of cell proliferation, induction or prevention of cell autophagy, alleviation of oxidative damage, and adaptation of hypoxia microenvironment.
- PNX may be associated with risk of developing PCOS. They proposed that PNX may provide a connection between multiple pathways contributing to PCOS including androgen action, insulin axis and apoptosis. PNX can serve as a new potential therapeutic target for PCOS patients undergo IVF and improved IVF outcome.
- Humanin is a small neuroprotective peptide identified from cDNA library of AD patient. Since its discovery, humanin has been shown to regulate many biological processes such as apoptosis, cell survival, metabolism, inflammation and oxidative stress. Published evidence suggests that humanin is secreted and expressed in many tissues, including the brain, retinal pigment epithelium, blood vessels, pancreatic beta cell, tumors and testes.
- Published evidence demonstrated the localization and distribution of humanin in human ovarian cells. Strong humanin expression was found in the ovary in multiple types of cells, including granulosa cells, oocytes and stromal cells. Further study revealed that follicular fluid humanin levels were correlated with ovarian reserve markers, and were associated with clinical pregnancy for women undergoing IVF-ICSI.
- Humanin is considered to exert a protective effect against apoptosis and oxidative stress. In preeclampsia, the rate of apoptosis was found to be increased, as a result of the oxidative stress that occurs in placenta.
- It is reported that abnormal insulin signaling is correlated with PCOS (11). IRS-1 is a key factor in insulin signaling pathway which has no kinase activity but its activity is regulated by phosphorylation/dephosphorylation. Serine phosphorylation,of IRS-1 would inhibit IRS-1 activity and block the activation of downstream signaling factors, leading to insulin resistance.
- There were no published data concerning humanin concentrations in pregnancy, especially in PCOS. Our study is the first to provide some expectations for such an association, demonstrating that humanin concentrations are increased in women with PCOS compared to controls.
- Autophagy is a lysosome mediated cellular process to clear misfolded protein, old or damaged organelle in the eukaryotes. Autophagy is an important mechanism to maintain cellular homeostasis and prevent tissue necrosis. Decreased expression of autophagy is associated with poor development of embryo and implantation failure. Moreover, Autophagy is physiologically involved in early normal gestation.
- mTOR is the crosstalk mediator between insulin signaling pathway and autophagy regulation. Insulin sensitivity is positively correlated with autophagy activity in pancreatic β cells, and insulin resistance is a common risk factor for both PCOS and type II diabetes.
- The present study demonstrate that humanin could regulate insulin signaling through IRS-1/mTOR in the hippocampus of APP/SP1 transgenic mice, decrease insulin resistance, improve autophagy in the neuron, decrease Aβ deposition and plaque formation, and improve learning ability and memory. These findings suggest that brain insulin signaling pathway, especially IRS-1/mTOR may be involved in autophagy regulation.
- Humanin treatment could enhance autophagy initiation and autophagy flux and decrease the accumulation of autophagosome to alleviate autophagy malfunction and improved IVF outcome in PCOS patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: qRTPCR (mRNA level).Group 1 (n=50): women (age 20-40year) with PCOS who are diagnosed according to the criteria of the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2003), which require two of the following 3 manifestations: 1. oligo- or anovulation, 2. clinical and/or biochemical signs of hyperandrogenism (> 2.08 nmol/l), 3. polycystic ovaries on ultrasound examination (the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume > 10 cm) |
| Group 2 | – | Genetic: qRTPCR (mRNA level).Group 2 (n=50): women (age 20-40 year) with male factor infertility. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- PCOS who are diagnosed according to the criteria of the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2003), which require two of the following 3 manifestations: 1. oligo- or anovulation, 2. clinical and/or biochemical signs of hyperandrogenism (> 2.08 nmol/l), 3. polycystic ovaries on ultrasound examination (the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume > 10 cm)
Key inclusion criteria (2 listed)
- • The diagnosis included donors, male factor infertility and PCOS women.
Key exclusion criteria (3 listed)
- • There were no other etiologies for the PCOS cases, such as congenital adrenal hyperplasia, 21-hydroxylase deficiency, androgen-secreting tumors, Cushing's syndrome, thyroid disease, and hyperprolactinemia.
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 |
|---|---|---|
| qRTPCR (mRNA level).Also: ELISA, western blot analysisRNA extraction and RT-qPCR Protein extraction and western blotting ELISA assay | Genetic | Group 1, Group 2 |
Primary outcome
Detect difference in expression of phoenixin and humanin in PCOS
Time frame: Baseline
Detect difference in expression of phoenixin and humanin markers in follicular fluid and their role in pathogenesis of PCOS.
Assess the link between phoenixin and humanin through the PI3/AKT/mTOR
Time frame: Baseline
Assess the link between phoenixin and humanin through the PI3/AKT/mTOR and autophagy signalling pathway that may be considered as a future therapeutic target in PCOS patients to improve IVF outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 30503199Rao M, Zhou F, Tang L, Zeng Z, Hu S, Wang Y, Ke D, Cheng G, Xia W, Zhang L, Zhu C. Follicular fluid humanin concentration is related to ovarian reserve markers and clinical pregnancy after IVF-ICSI: a pilot study. Reprod Biomed Online. 2019 Jan;38(1):108-117. doi: 10.1016/j.rbmo.2018.11.002. Epub 2018 Nov 23.
- Background: PubMed 30933929Nguyen XP, Nakamura T, Osuka S, Bayasula B, Nakanishi N, Kasahara Y, Muraoka A, Hayashi S, Nagai T, Murase T, Goto M, Iwase A, Kikkawa F. Effect of the neuropeptide phoenixin and its receptor GPR173 during folliculogenesis. Reproduction. 2019 Jul;158(1):25-34. doi: 10.1530/REP-19-0025.
- Background: PubMed 25544676Avagliano L, Terraneo L, Virgili E, Martinelli C, Doi P, Samaja M, Bulfamante GP, Marconi AM. Autophagy in Normal and Abnormal Early Human Pregnancies. Reprod Sci. 2015 Jul;22(7):838-44. doi: 10.1177/1933719114565036. Epub 2014 Dec 28.
- Background: PubMed 27664216Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.
- 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.
Madiha Mahros Zakhary farag, Professor principal investigator
Faculty of medicin Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Engy Mohamed Fikry, As. lecture (01007021214, dr.engyfikry@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect difference in expression of phoenixin and humanin in PCOS (time frame: Baseline). 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 NCT04104958, which also lists 4 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 10 Jan 2020.