Polycystic Ovary Syndrome
Conditions
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.
Detailed description
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.
Interventions
OTHERLong-term follow-up
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.
Sponsors
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* PCOS patients diagnosed using the Rotterdam criteria, which requires the presence of at least two of the following: 1. Menstrual Irregularities: A menstrual cycle length of fewer than 21 days or more than 35 days, and/or fewer than eight cycles per year. 2. 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. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (Türkiye), United States
Contacts
Primary ContactZi-jiang Chen
Outcome results
None listed