Novel Subtypes of Polycystic Ovary Syndrome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HA-PCOS 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
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.
|
| OB-PCOS 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
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.
|
| SHBG-PCOS 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
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.
|
| LH-PCOS 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
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.
|
Outcome Measures
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn State College of Medicine | Hershey | Pennsylvania | United States | 17033 |
| 2 | Chengdu Jinjiang Maternity and Child Health Hospital | Chengdu | China | ||
| 3 | Guangdong Second Provincial General Hospital | Guangzhou | China | ||
| 4 | Shandong University | Jinan | China | 250012 | |
| 5 | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai | China | ||
| 6 | Tianjin Medical University General Hospital | Tianjin | China | ||
| 7 | General Hospital of Ningxia Medical University | Yinchuan | China | ||
| 8 | Oulu University Hospital | Oulu | Finland | ||
| 9 | National University Hospital, National University of Singapore | Singapore | Singapore | ||
| 10 | Karolinska Institutet | Solna | Sweden | 17165 | |
| 11 | Hacettepe University School of Medicine Hacettepe | Ankara | Turkey |
Sponsors and Collaborators
- Shandong University
Investigators
- Study Chair: Zi-jiang Chen, Center for Reproductive Medicine, Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCOS-Subtypes