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NCT07739940
Clinical Research Cohort for Polycystic Ovary Syndrome
Conditions: PCOS (Polycystic Ovary Syndrome)
Sex: Female
Ages: 16 Years – 45 Years
Enrollment: 420
Sponsor: Guangdong Women and Children Hospital
Location: Guangdong Women and Children Hospital Guangzhou
Summary
Polycystic Ovary Syndrome (PCOS) is a multifactorial metabolic-endocrine disorder characterized by hyperandrogenism, ovulatory dysfunction, and polycystic ovarian morphology. According to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, its global prevalence ranges from 10% to 13%, making it one of the major diseases affecting women's health across the entire lifespan. The clinical manifestations of PCOS are highly heterogeneous, leading to menstrual disturbances (such as amenorrhea and abnormal uterine bleeding), infertility, insulin resistance, and an increased risk of type 2 diabetes mellitus in adolescent and reproductive-aged women. In the long term, it may further result in serious complications including diabetes, cardiovascular disease, endometrial hyperplasia, and even malignancy. In addition, pregnant women with PCOS have a significantly increased risk of adverse obstetric outcomes such as spontaneous miscarriage and preeclampsia. Therefore, PCOS requires long-term, systematic clinical management and multidisciplinary collaborative intervention.
However, the long-term follow-up management of PCOS patients faces considerable challenges. Clinical studies have shown that the majority of patients find it difficult to adhere to regular follow-up protocols. On the one hand, this is due to patients' insufficient awareness of the disease, often neglecting its potential long-term health risks; on the other hand, it is attributed to the unequal distribution of healthcare resources, particularly the lack of comprehensive follow-up management systems in primary healthcare facilities. Furthermore, existing clinical research data have notable limitations, making it difficult to provide precise guidance for clinical practice. Therefore, establishing a standardized PCOS clinical research cohort is of significant clinical value. Through the systematic collection of long-term follow-up data, it is possible to comprehensively evaluate the evolution patterns of health risks across different life stages of patients. Cohort studies are conducive to in-depth analysis of the key factors influencing disease progression and provide a scientific basis for clinical risk-stratified management.
Eligibility Criteria
I. Diagnostic Criteria: 2023 International Evidence-based Guidelines for the Assessment and Management of Polycystic Ovary Syndrome
II. Inclusion and Exclusion Criteria:
1. PCOS Group
Inclusion Criteria:
Meets the above PCOS diagnostic criteria; Voluntarily signs the informed consent form; Has complete baseline clinical data (including hormonal, metabolic, and ultrasound parameters).
Exclusion Criteria:
Other conditions causing hyperandrogenism or ovulatory dysfunction; Use of hormonal medications within 3 months; Concurrent severe cardiac, hepatic, or renal diseases; Mental disorders that preclude compliance with follow-up.
2. Control Group
Inclusion Criteria:
Age- and BMI-matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.
Source: ClinicalTrials.gov (NCT07739940). StuddyBuddy aggregates publicly available trial information.