Novel Subtypes of Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Long-term follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HA-PCOS<br>Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the HA-PCOS group is hyperandrogenism. | Other: Long-term follow-up<br>* 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.<br>|
| OB-PCOS<br>Patients were classified into each PCOS subtype based on our machine-learning classification model. The feature of the OB-PCOS group is overweight/obesity. | Other: Long-term follow-up<br>* 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.<br>|
| SHBG-PCOS<br>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. | Other: Long-term follow-up<br>* 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.<br>|
| LH-PCOS<br>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. | Other: Long-term follow-up<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: 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 | 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. |