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NCT Number: NCT07739940

Clinical Research Cohort for Polycystic Ovary Syndrome

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.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

I. Diagnostic Criteria: 2023 International Evidence-based Guidelines for the Assessment and Management of Polycystic Ovary Syndrome

II. Inclusion and Exclusion Criteria:

  • 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.

  • Control Group

Inclusion criteria

Age- and BMI-matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.

Treatment and study plan

Primary outcomes

  1. Pregnancy-related outcomes and long-term complications

    Time frame: 1year

Sponsors and collaborators

Lead sponsor

Guangdong Women and Children Hospital

Other

Registry information

Official study title

Clinical Research Cohort for Polycystic Ovary Syndrome (PCOS)

Acronym: PCOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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