Polycystic Ovary SyndromeNCT06124391
Novel Subtypes of Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Shandong University at 11 sites in 6 countries.
Trial summary
To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Long-term follow-up
- How many people
- 50,000 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 1 Jan 2021to 30 Dec 2025
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Discovery cohort: Patients diagnosed with PCOS who sought care at the Center for Reproductive Medicine, Shandong University between December 2013 and June 2020. * The validation cohorts of this study consist of four populations. 1. China Validation Cohort: Consists of patients from various regions in China, excluding Shandong. 2. America Validation Cohort: Participants from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial. 3. Singapore Validation Cohort. 4. Europe Validation Cohort: Comprising patients from Turkey.
Who may be able to join
- PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:
- Menstrual Irregularities: A menstrual cycle length of fewer than 21 days or more than 35 days, and/or fewer than eight cycles per year.
- Hyperandrogenism: Defined either by an elevated total testosterone level (as per local laboratory criteria) or by a modified Ferriman-Gallwey (mFG) score of 5 or higher.
- Polycystic Ovaries on Ultrasound: Presence of 12 or more follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume exceeding 10 mL.
Who cannot join
- Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
China6 sites, 6 recruiting
- Recruiting
Chengdu Jinjiang Maternity and Child Health Hospital
Chengdu
Lin Zhou, linzhoucdjj@gmail.com
- Recruiting
Guangdong Second Provincial General Hospital
Guangzhou
Xianghong Ou, ouxianghong@yahoo.com.cn
- Recruiting
Shandong University
Jinan, 250012
Zi-jiang Chen, 86-531-85187856, chenzijiang@hotmail.com
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Yun Sun, syun163@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin
Ye Tian, tianyesdu@126.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan
Junli Zhao, zhaojunli6812@163.com
United States1 site, 1 recruiting
- Recruiting
Penn State College of Medicine
Hershey, Pennsylvania, 17033
Richard Legro, rsl1@psu.edu
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre
Poli Spritzer, spritzer@ufrgs.br
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital, National University of Singapore
Singapore
Eu-Leong Yong, obgyel@nus.edu.sg
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Solna, 17165
Elisabet Stener-Victorin, elisabet.stener-victorin@ki.se
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University School of Medicine Hacettepe
Ankara
Bulent Yildiz, yildizbo@yahoo.com
About this study
Official title: An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study
To classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes.
Read the detailed description
In this study, we've developed a machine-learning model to classify PCOS patients into four subtypes based on nine clinical characteristics.
The goal of this observational study is to:
- Learn about different PCOS subtypes using our classification model.
- Compare the reproductive and metabolic features of these subtypes.
- Assess the outcomes of IVF among different PCOS subtypes.
- Prospective 6.5-year follow-up data will be collected.
Participants will:
- Undergo a telephone interview to gather details on:
- Current physical stats like height and weight.
- Reproductive history, including pregnancies and childbirths in recent years.
- Details about any IVF treatments.
- Current status of conditions such as PCOS, Type 2 Diabetes, hypertension, and dyslipidemia.
- Be invited for a physical examination that includes:
- Measurements such as height, weight, blood pressure, and body circumferences.
- Laboratory tests for endocrine and metabolic conditions.
- Ultrasound scans of the ovaries and liver.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Long-term follow-up
- 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.
Long-term follow-upOther
Participants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions.
| Study group | Role | What they receive |
|---|---|---|
| HA-PCOS | Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the HA-PCOS group is hyperandrogenism. Receives: Other: Long-term follow-up | |
| OB-PCOS | Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the OB-PCOS group is overweight/obesity. Receives: Other: Long-term follow-up | |
| SHBG-PCOS | Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the SHBG-PCOS group is the high level of serum SHBG. Receives: Other: Long-term follow-up | |
| LH-PCOS | Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the LH-PCOS group is the high level of LH and AMH. Receives: Other: Long-term follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of PCOS Diagnosis
Determining if patients still meet the Rotterdam criteria for a PCOS diagnosis at the follow-up. The hyperandrogenic, ovulatory, and polycystic ovarian conditions at the follow-up time will be assessed.
Measured: At the 6.5-year follow-up visit.
Changes in PCOS Subtype
Tracking if patients have transitioned between different PCOS subtypes at the follow-up.
Measured: At the 6.5-year follow-up visit.
Body Mass Index
Patients' weight (in kilograms) and height (in meters) will be collected and combined to report BMI in kg/m^2
Measured: At the 6.5-year follow-up visit.
Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD will be assessed using abdominal ultrasound.
Measured: At the 6.5-year follow-up visit.
Hypertension
Blood pressure will be assessed, and we will determine if a patient has hypertension, defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg.
Measured: At the 6.5-year follow-up visit.
Type 2 Diabetes Mellitus (T2DM)
Fasting glucose will be assessed, and we will determine if a patient has T2DM, defined as fasting glucose ≥ 7.0 mmol/l.
Measured: At the 6.5-year follow-up visit.
Dyslipidemia
Defined as the presence of any of the following abnormalities:
- Total cholesterol ≥ 5.2 mmol/l
- Triglycerides (TG) ≥ 1.7 mmol/l
- High-density lipoprotein (HDL) < 1.0 mmol/l
- Low-density lipoprotein (LDL) ≥ 3.35 mmol/l
Measured: At the 6.5-year follow-up visit.
Total live birth rate
Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Measured: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Clinical pregnancy rate
Clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
Measured: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Pregnancy loss rate
Pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Measured: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Maternal and neonatal complications
Any maternal and neonatal complications, including gestational diabetes, preeclampsia, etc., will be collected.
Measured: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jan 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Zi-Jiang, Shandong University
- Investigators
- Zi-jiang Chen, Study chair, Center for Reproductive Medicine, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124391
- Sponsor's protocol ID
- PCOS-Subtypes
- Status last verified
- Nov 2023
- First submitted
- 26 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study
- ClinicalTrials.gov ID
- NCT06124391
- Acronym / sponsor ID
- PCOS-Subtypes
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Nov 2023 (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 classify subtypes of Polycystic Ovary Syndrome (PCOS) using machine-learning algorithms, and compare the reproductive and metabolic characteristics and IVF outcomes across these identified subtypes.
Detailed description
In this study, we've developed a machine-learning model to classify PCOS patients into four subtypes based on nine clinical characteristics.
The goal of this observational study is to:
- Learn about different PCOS subtypes using our classification model.
- Compare the reproductive and metabolic features of these subtypes.
- Assess the outcomes of IVF among different PCOS subtypes.
- Prospective 6.5-year follow-up data will be collected.
Participants will:
- Undergo a telephone interview to gather details on:
- Current physical stats like height and weight.
- Reproductive history, including pregnancies and childbirths in recent years.
- Details about any IVF treatments.
- Current status of conditions such as PCOS, Type 2 Diabetes, hypertension, and dyslipidemia.
- Be invited for a physical examination that includes:
- Measurements such as height, weight, blood pressure, and body circumferences.
- Laboratory tests for endocrine and metabolic conditions.
- Ultrasound scans of the ovaries and liver.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HA-PCOS | – | Other: Long-term follow-upPatients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the HA-PCOS group is hyperandrogenism. |
| OB-PCOS | – | Other: Long-term follow-upPatients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the OB-PCOS group is overweight/obesity. |
| SHBG-PCOS | – | Other: Long-term follow-upPatients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the SHBG-PCOS group is the high level of serum SHBG. |
| LH-PCOS | – | Other: Long-term follow-upPatients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the LH-PCOS group is the high level of LH and AMH. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Discovery cohort: Patients diagnosed with PCOS who sought care at the Center for Reproductive Medicine, Shandong University between December 2013 and June 2020. * The validation cohorts of this study consist of four populations. 1. China Validation Cohort: Consists of patients from various regions in China, excluding Shandong. 2. America Validation Cohort: Participants from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial. 3. Singapore Validation Cohort. 4. Europe Validation Cohort: Comprising patients from Turkey.
Key inclusion criteria (4 listed)
- PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:
Key exclusion criteria (1 listed)
- Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.
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 |
|---|---|---|
| Long-term follow-upParticipants diagnosed with PCOS were not subjected to any specific intervention post-diagnosis. Instead, they were followed up after 6.5 years to assess various outcomes related to PCOS and associated conditions. | Other | HA-PCOS, LH-PCOS, OB-PCOS, SHBG-PCOS |
Primary outcome
Persistence of PCOS Diagnosis
Time frame: At the 6.5-year follow-up visit.
Determining if patients still meet the Rotterdam criteria for a PCOS diagnosis at the follow-up. The hyperandrogenic, ovulatory, and polycystic ovarian conditions at the follow-up time will be assessed.
Changes in PCOS Subtype
Time frame: At the 6.5-year follow-up visit.
Tracking if patients have transitioned between different PCOS subtypes at the follow-up.
Body Mass Index
Time frame: At the 6.5-year follow-up visit.
Patients' weight (in kilograms) and height (in meters) will be collected and combined to report BMI in kg/m^2
Non-Alcoholic Fatty Liver Disease (NAFLD)
Time frame: At the 6.5-year follow-up visit.
NAFLD will be assessed using abdominal ultrasound.
Hypertension
Time frame: At the 6.5-year follow-up visit.
Blood pressure will be assessed, and we will determine if a patient has hypertension, defined as systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg.
Type 2 Diabetes Mellitus (T2DM)
Time frame: At the 6.5-year follow-up visit.
Fasting glucose will be assessed, and we will determine if a patient has T2DM, defined as fasting glucose ≥ 7.0 mmol/l.
Dyslipidemia
Time frame: At the 6.5-year follow-up visit.
Defined as the presence of any of the following abnormalities: * Total cholesterol ≥ 5.2 mmol/l * Triglycerides (TG) ≥ 1.7 mmol/l * High-density lipoprotein (HDL) < 1.0 mmol/l * Low-density lipoprotein (LDL) ≥ 3.35 mmol/l
Total live birth rate
Time frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Clinical pregnancy rate
Time frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
Pregnancy loss rate
Time frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Maternal and neonatal complications
Time frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.
Any maternal and neonatal complications, including gestational diabetes, preeclampsia, etc., will be collected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Zi-jiang Chen study chair
Center for Reproductive Medicine, Shandong University
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Shandong University at 11 sites in 6 countries.
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 4 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, United States, Brazil, Singapore, Sweden and 1 more country. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi-jiang Chen (86-531-85187856, chenzijiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of PCOS Diagnosis (time frame: At the 6.5-year follow-up visit.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2023.