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RecruitingNCT07571096Updated Jul 30, 2026

Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia

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

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
14 Years to 45 Years
Sex
Female
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Study 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). 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.

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Conditions studied

  • Polycystic Ovary Syndrome (PCOS)
  • Thrombophilia
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In context

Polycystic Ovary Syndrome

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.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Guangdong Women and Children Hospital is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function

Exclusion criteria

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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 35702093 ↗
  • Zhong 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07571096
Lead sponsor
Guangdong Women and Children Hospital
Responsible party
Li Li (PhD, Guangdong Women and Children Hospital) — Principal investigator
First posted
May 6, 2026
Start date
Mar 4, 2025
Primary completion
Aug 1, 2026 (estimated)
Completion
Mar 17, 2027 (estimated)
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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