Clinical trial · Observational
Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
NCT07571096CI-TRIAL-00119839recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
| Thrombophilia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- PCOS with decreased protein C and/or protein S
- description
- Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and with decreased protein C and/or protein S levels.
- label
- PCOS without decreased protein C or protein S
- description
- Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and without decreased protein C or protein S levels.
Primary outcomes (1)
- measure
- Decreased protein C and/or protein S levels
- timeFrame
- At baseline
- description
- Assessment of decreased protein C and/or protein S levels in women with polycystic ovary syndrome at study enrollment based on laboratory testing.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 14 to 45 years * Diagnosis of polycystic ovary syndrome (PCOS) * For adult participants, PCOS diagnosed according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate * For adolescent participants, PCOS 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 * Irregular menstrual cycles are defined as follows: more than 1 year and less than 3 years after menarche, menstrual cycles shorter than 21 days or longer than 45 days; more than 3 years after menarche to perimenopause, menstrual cycles shorter than 21 days or longer than 35 days, or fewer than 8 cycles per year; any cycle longer than 90 days more than 1 year after menarche; or primary amenorrhea by age 15 years or more than 3 years after thelarche * No use within 3 months before blood sampling of anticoagulant drugs, procoagulant drugs, oral contraceptives, or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function Exclusion Criteria: * Confirmed pregnancy * Hematologic disease * History of malignant tumor * Use of medications within 12 weeks before enrollment that may interfere with study assessments * Disorders that may cause hyperandrogenism or ovulatory dysfunction, including congenital adrenal hyperplasia, Cushing syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, or primary ovarian insufficiency * Disorders that may affect protein C or protein S levels, including antiphospholipid syndrome, liver disease, or tumor-related conditions * In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS
References
Publications (2)
- RESULTChen X, Tao C, Wang J, He B, Xu J. Meta-analysis of therapeutic efficacy and effects of integrated traditional Chinese and Western medicine on coagulation and fibrinolysis system in patients with threatened abortion and polycystic ovary syndrome. Am J Transl Res. 2022 May 15;14(5):2768-2778. eCollection 2022. PMID 35702093
- RESULTZhong M, Tu Y, Peng X, Song Y, Zhou J, Zhang X, Xu Q, Li L. A case of polycystic ovary syndrome with inevitable miscarriage and multi-site venous thrombosis caused by hereditary protein C deficiency. Gynecol Endocrinol. 2022 Dec;38(12):1153-1157. doi: 10.1080/09513590.2022.2162034. Epub 2023 Jan 12. PMID 36634704