Brief 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.

Conditions

• Polycystic Ovary Syndrome

Intervention / Treatment

• Other: Long-term follow-up

Primary Outcome Measures

• Persistence of PCOS Diagnosis (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 (At the 6.5-year follow-up visit.)
  Tracking if patients have transitioned between different PCOS subtypes at the follow-up.
• Body Mass Index (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) (At the 6.5-year follow-up visit.)
  NAFLD will be assessed using abdominal ultrasound.
• Hypertension (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) (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 (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 (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 (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 (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 (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.

Countries

Brazil, China, Singapore, Sweden, Turkey, United States

Locations and Investigators

• Penn State College of Medicine, Hershey, United States (Recruiting)
  • Richard Legro
• Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil (Recruiting)
  • Poli Spritzer
• Chengdu Jinjiang Maternity and Child Health Hospital, Chengdu, China (Recruiting)
  • Lin Zhou
• Guangdong Second Provincial General Hospital, Guangzhou, China (Recruiting)
  • Xianghong Ou
• Shandong University, Jinan, China (Recruiting)
  • Zi-jiang Chen
• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (Recruiting)
  • Yun Sun
• Tianjin Medical University General Hospital, Tianjin, China (Recruiting)
  • Ye Tian
• General Hospital of Ningxia Medical University, Yinchuan, China (Recruiting)
  • Junli Zhao
• National University Hospital, National University of Singapore, Singapore, Singapore (Recruiting)
  • Eu-Leong Yong
• Karolinska Institutet, Solna, Sweden (Recruiting)
  • Elisabet Stener-Victorin
• Hacettepe University School of Medicine Hacettepe, Ankara, Turkey (Recruiting)
  • Bulent Yildiz

Study Officials

• Zi-jiang Chen (Study Chair) — Center for Reproductive Medicine, Shandong University