Actively Recruiting
Led by Guangdong Women and Children Hospital · Updated on 2026-05-06
100
Participants Needed
1
Research Sites
32 weeks
Total Duration
This research aims to develop a multidimensional risk assessment model for abnormalities related to thrombophilia in females with polycystic ovary syndrome (PCOS). It focuses on analyzing endocrine, metabolic, and genetic factors linked to decreased protein C and/or protein S levels in females aged 14 to 45 years. The study is observational and compares participants with and without these decreased protein levels to better understand risk factors associated with PCOS and thrombophilia. Female participants diagnosed with PCOS according to specific international guidelines will be enrolled and classified into two groups based on whether they have decreased protein C and/or protein S levels. Adults are diagnosed based on ovulatory dysfunction or irregular menstrual cycles combined with hyperandrogenism or ultrasound findings, while adolescents require both ovulatory dysfunction and hyperandrogenism. The study collects endocrine, metabolic, and genetic data for analysis, including various statistical methods to develop the risk model. Participants will undergo baseline assessments to measure protein C and protein S levels and other variables related to their endocrine and metabolic health. Researchers will analyze data to identify risk factors and evaluate model performance. The primary outcome is the presence of decreased protein C and/or protein S levels at baseline. The study will run until March 2027 and aims to support personalized management strategies for females with PCOS and thrombophilia risk.
CONDITIONS
Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo diagnostic assessments to confirm polycystic ovary syndrome (PCOS) and to measure protein C and protein S levels.
1 baseline visit (in-person)
Duration - Up to study completion (approximately 3 years)
Participants are observed over time to collect endocrine, metabolic, and genetic data for analysis of thrombophilia-related risk factors in PCOS.
Additional assessments may occur depending on cohort assignment
Total: 1 location
1
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Actively Recruiting
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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