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: * 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: 1. Current physical stats like height and weight. 2. Reproductive history, including pregnancies and childbirths in recent years. 3. Details about any IVF treatments. 4. Current status of conditions such as PCOS, Type 2 Diabetes, hypertension, and dyslipidemia. * Be invited for a physical examination that includes: 1. Measurements such as height, weight, blood pressure, and body circumferences. 2. Laboratory tests for endocrine and metabolic conditions. 3. Ultrasound scans of the ovaries and liver.
Study Type
OBSERVATIONAL
Enrollment
50,000
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.
Penn State College of Medicine
Hershey, Pennsylvania, United States
RECRUITINGHospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
RECRUITINGPersistence 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.
Time frame: 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.
Time frame: 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
Time frame: At the 6.5-year follow-up visit.
Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD will be assessed using abdominal ultrasound.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At the 6.5-year follow-up visit.
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Chengdu Jinjiang Maternity and Child Health Hospital
Chengdu, China
RECRUITINGGuangdong Second Provincial General Hospital
Guangzhou, China
RECRUITINGShandong University
Jinan, China
RECRUITINGRen Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, China
RECRUITINGGeneral Hospital of Ningxia Medical University
Yinchuan, China
RECRUITINGNational University Hospital, National University of Singapore
Singapore, Singapore
RECRUITINGKarolinska Institutet
Solna, Sweden
RECRUITING...and 1 more locations
Total live birth rate
Live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the diagnosis of PCOS (at the time of enrollment) until a follow-up period of 6.5 years.