Polycystic Ovary Syndrome (PCOS)NCT07571096
Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia
An observational study of Polycystic Ovary Syndrome (PCOS) and Thrombophilia, run by Guangdong Women and Children Hospital at 1 site in China.
Trial summary
This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Thrombophilia
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2025to 17 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Women and Children Hospital
Guangzhou, Guangdong
Li Li, 13631446859, lili-1406@163.com
About this study
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.
Read the detailed description
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.
- Conditions
- Polycystic Ovary Syndrome (PCOS), Thrombophilia
- Medical subject headings
- Polycystic Ovary Syndrome, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCOS with decreased protein C and/or protein S | Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and with decreased protein C and/or protein S levels. | |
| PCOS without decreased protein C or protein S | Female participants aged 14 to 45 years diagnosed with polycystic ovary syndrome and without decreased protein C or protein S levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start4 Mar 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion17 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Guangdong Women and Children Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571096
- Sponsor's protocol ID
- GuangdongWCH-Li Li05
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen 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.
PubMed 35702093Zhong 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.
PubMed 36634704