Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50000 participants
OBSERVATIONAL
2021-01-01
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Shandong University
OTHER
Responsible Party
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Chen Zi-Jiang
Academician
Principal Investigators
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Zi-jiang Chen
Role: STUDY_CHAIR
Center for Reproductive Medicine, Shandong University
Locations
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Penn State College of Medicine
Hershey, Pennsylvania, United States
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Chengdu Jinjiang Maternity and Child Health Hospital
Chengdu, , China
Guangdong Second Provincial General Hospital
Guangzhou, , China
Shandong University
Jinan, , China
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
National University Hospital, National University of Singapore
Singapore, , Singapore
Karolinska Institutet
Solna, , Sweden
Hacettepe University School of Medicine Hacettepe
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Richard Legro
Role: primary
Poli Spritzer
Role: primary
Lin Zhou
Role: primary
Xianghong Ou
Role: primary
Zi-jiang Chen
Role: primary
Yun Sun
Role: primary
Ye Tian
Role: primary
Junli Zhao
Role: primary
Eu-Leong Yong
Role: primary
Elisabet Stener-Victorin
Role: primary
Bulent Yildiz
Role: primary
Other Identifiers
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PCOS-Subtypes
Identifier Type: -
Identifier Source: org_study_id