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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.
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:
Participants will:
Undergo a telephone interview to gather details on:
Be invited for a physical examination that includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-term follow-up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | At the 6.5-year follow-up visit. |
| Non-Alcoholic Fatty Liver Disease (NAFLD) | NAFLD will be assessed using abdominal ultrasound. | 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. | 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. | At the 6.5-year follow-up visit. |
| Dyslipidemia | Defined as the presence of any of the following abnormalities:
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Inclusion Criteria:
PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following:
Exclusion Criteria:
Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi-jiang Chen | Contact | 86-531-85187856 | chenzijiang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zi-jiang Chen | Center for Reproductive Medicine, Shandong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Recruiting | Hershey | Pennsylvania | 17033 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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Whole blood and plasma samples will be collected.
| 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. | 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. | 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. | 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. | From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years. |
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Brazil |
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| Chengdu Jinjiang Maternity and Child Health Hospital | Recruiting | Chengdu | China |
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| Guangdong Second Provincial General Hospital | Recruiting | Guangzhou | China |
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| Shandong University | Recruiting | Jinan | 250012 | China |
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| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | China |
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| Tianjin Medical University General Hospital | Recruiting | Tianjin | China |
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| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | China |
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| National University Hospital, National University of Singapore | Recruiting | Singapore | Singapore |
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| Karolinska Institutet | Recruiting | Solna | 17165 | Sweden |
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| Hacettepe University School of Medicine Hacettepe | Recruiting | Ankara | Turkey (Türkiye) |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |