An Evidence-Based Novel Subtypes of Polycystic Ovary Syndrome and Their Association With Outcomes: a Large Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 11
- 主要终点
- Non-Alcoholic Fatty Liver Disease (NAFLD)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Patients with congenital adrenal hyperplasias, androgen-secreting tumours, or Cushing's syndrome) will be excluded.
结局指标
主要结局
Non-Alcoholic Fatty Liver Disease (NAFLD)
时间窗: At the 6.5-year follow-up visit.
NAFLD will be assessed using abdominal ultrasound.
Clinical pregnancy rate
时间窗: 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.
Changes in PCOS Subtype
时间窗: At the 6.5-year follow-up visit.
Tracking if patients have transitioned between different PCOS subtypes at the follow-up.
Hypertension
时间窗: 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.
Dyslipidemia
时间窗: 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
Pregnancy loss rate
时间窗: 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.
Persistence of PCOS Diagnosis
时间窗: 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.
Type 2 Diabetes Mellitus (T2DM)
时间窗: 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.
Body Mass Index
时间窗: 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
Total live birth rate
时间窗: 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.
Maternal and neonatal complications
时间窗: 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.
次要结局
未报告次要终点
研究者
Chen Zi-Jiang
Academician
Shandong University