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

NCT07571096 | Recruiting

• 1 other identifier: GuangdongWCH-Li Li05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome (PCOS); Thrombophilia

Outcome Measures

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.

  At baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Female participants aged 14 to 45 years
• Diagnosis of polycystic ovary syndrome (PCOS)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 35702093 RESULT

• 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.

  PMID: 36634704 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Thrombophilia

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: March 4, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 17, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (1)