An observational study in PCOS (Polycystic Ovary Syndrome), sponsored by Guangdong Women and Children Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Guangdong Women and Children Hospital · Observational
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.
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's planned enrollment of 420 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →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.
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.
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 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.
Inclusion Criteria:
Age- and -matched healthy females; Regular menstrual cycles (21-35 days); No clinical manifestations or biochemical evidence of hyperandrogenism.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnancy-related outcomes and long-term complications
Time frame: 1year
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Guangdong Women and Children Hospital