An observational study in Polycystic Ovary Syndrome (PCOS) and Thrombophilia, sponsored by Guangdong Women and Children Hospital. Recruiting at 1 site in China. Open to female participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Guangdong Women and Children Hospital · Observational
This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and/or protein S levels in participants with PCOS. The results are expected to provide evidence for risk stratification and individualized management in this population.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in females of reproductive age and is frequently associated with metabolic dysfunction and an increased risk of thrombosis. This study is designed as an observational case-control study to investigate multidimensional risk factors associated with thrombophilia-related abnormalities in females with PCOS.
Female participants aged 14 to 45 years will be enrolled. Adult participants will be diagnosed with PCOS according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis in adults is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate. Adolescent participants will be diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and/or irregular menstrual cycles and clinical or biochemical hyperandrogenism are required. Polycystic ovarian morphology alone will not be used to diagnose PCOS in adolescents.
Participants will be classified into a case group and a control group according to the presence or absence of decreased protein C and/or protein S levels. Endocrine, metabolic, and genetic variables will be collected and analyzed. Statistical analyses will include descriptive analysis, group comparisons, univariable analysis, multivariable logistic regression, and model performance evaluation using receiver operating characteristic curves and the area under the curve.
The primary outcome is decreased protein C and/or protein S levels at baseline. The goal of this study is to construct a multidimensional risk assessment model for thrombophilia-related abnormalities in females with PCOS and to provide evidence for risk stratification and individualized management.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 100 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
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Female participants aged 14 to 45 years with polycystic ovary syndrome will be enrolled. Participants will be classified according to the presence or absence of decreased protein C and/or protein S levels.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and with decreased protein C and/or protein S levels.
Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and without decreased protein C or protein S levels.
Decreased protein C and/or protein S levels
Assessment of decreased protein C and/or protein S levels in women with polycystic ovary syndrome at study enrollment based on laboratory testing.
Time frame: At baseline
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Guangdong Women and Children Hospital