Clinical Research Cohort for Polycystic Ovary Syndrome

NCT07739940 | Active Not Recruiting DMC

• 2 other identifiers: GuangdongWCH-Li Li20250131
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (1)

• Pregnancy-related outcomes and long-term complications

  1year

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll patients diagnosed with Polycystic Ovary Syndrome (PCOS) according to the 2023 International Evidence-based Guidelines for the Assessment and Management of PCOS, as well as age- and BMI-matched healthy controls with regular menstrual cycles. Participants will be recruited from the outpatient clinics of Guangdong Women and Children Hospital. Eligible participants will be consecutively enrolled on a voluntary basis after signing informed consent. Baseline clinical data including hormonal, metabolic, and ultrasound parameters will be collected at enrollment. All participants will be followed longitudinally to assess pregnancy-related outcomes and long-term complications.

You may not qualify if:

• PCOS Group
• Meets the above PCOS diagnostic criteria; Voluntarily signs the informed consent form; Has complete baseline clinical data (including hormonal, metabolic, and ultrasound parameters).
• 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
• Age- and BMI-matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CN (1)