Polycystic ovary syndrome
Conditions
Interventions
Gold Standard:Meets the 2003 Rotterdam diagnostic criteria and has been clinically evaluated to rule out other disorders potentially causing ovulatory dysfunction or hyperandrogenism.
Index test:Serum Kisspeptin-1 ELISA
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: **Case Group:** 1. Age 20–40 years; 2. Meet the 2003 Rotterdam diagnostic criteria, requiring at least 2 of the following 3 features, with other causes of ovulatory dysfunction or hyperandrogenism excluded by clinical assessment: (1) Ovulatory dysfunction, manifested as anovulation or oligo-ovulation; (2) Clinical signs of hyperandrogenism (e.g., hirsutism, acne) or biochemical evidence of hyperandrogenemia; (3) Ultrasound findings suggestive of polycystic ovarian morphology (PCOM), defined as =12 follicles measuring 2–9 mm in diameter in at least one ovary and/or ovarian volume =10 mL; 3. No use of medications affecting glucose-lipid metabolism or sex hormone levels within the past 3 months (see Exclusion Criterion 4); 4. Venous blood sampling was performed during the study period for routine clinical care, with test items including at least sex hormones, fasting glucose and insulin, and lipid profiles; the laboratory confirmed the availability of sufficient (=200 µL) qualified residual serum samples for research use; 5. Voluntary signing of informed consent. **Control Group:** 1. Frequency-matched to the PCOS group by age (within ±5-year age bands); 2. Regular menstrual cycles; 3. No clinical signs of hyperandrogenism (e.g., hirsutism, moderate-to-severe acne) or biochemical hyperandrogenemia; 4. PCOS and other endocrine-metabolic diseases excluded by clinical assessment; confirmed as healthy individuals attempting conception or patients with infertility due solely to male factors (e.g., asthenospermia, oligospermia, abnormal semen parameters, sexual dysfunction); 5. Comply with Case Group Criteria 3, 4, and 5.
Exclusion criteria
Exclusion criteria: **All Participants:** 1. Age >40 years or <20 years; 2. Presence of other diseases that may cause ovulatory dysfunction or hyperandrogenism; 3. Presence of organic reproductive system lesions that may significantly affect fertility or independently cause infertility; 4. Use of any medications known to clearly affect sex hormone levels or glucose-lipid metabolism within the past 3 months, including but not limited to: psychotropic drugs, glucocorticoids, hormonal contraceptives, anti-androgens, ovulation-inducing agents, insulin and hypoglycemic drugs, weight-loss drugs, etc.; 5. Presence of various chronic systemic diseases affecting cardiopulmonary, hepatic, or renal function; 6. History of acute infection, unresolved chronic infection, surgery, or severe trauma; 7. Serum sample quality does not meet testing requirements; 8. Severe deficiency in clinical data; 9. Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in serum Kisspeptin-1 levels and reproductive endocrine metabolic indicators between two groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in serum Kisspeptin-1 levels and reproductive endocrine metabolic indicators among different internal phenotypes of PCOS;AUC value; | — |
Countries
China
Contacts
Public ContactZhang Ying
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed