polycystic ovary syndrome
Conditions
Interventions
Bromocriptine intervention group 1:Bromocriptine mesylate tablets (Bimoting) were given orally 1.25mg each time, twice a day for 24 weeks
The metformin group:Metformin hydrochloride sustained-release tablets (Gwaze) were given orally, 0.5g each time, twice a day, for 24 weeks
Metformin combined with bromocriptine group:Metformin hydrochloride sustained-release tablets (Gehuazhi), 0.5g each time, twice a day, orally, and bromocriptine mesylate tablets (Bimoting), 1.25mg eac
Bromocriptine intervention group 2:Bromocriptine mesylate tablets (Bimoting) were given orally 1.25mg each time, twice a day for 24 weeks
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 and 10 mL. Exclusion of secondary causes: Congenital adrenal hyperplasia, hyperprolactinemia, thyroid dysfunction, Cushing's syndrome, and androgen-secreting tumors must be ruled out. 3. Confirmed PCOS diagnosis with no history of hormonal, pharmacological, or lifestyle interventions for PCOS within the preceding 3 months.
Exclusion criteria
Exclusion criteria: Individuals meeting any of the following criteria will be excluded: 1. Active smoking (>5 cigarettes/day) or alcohol abuse (>=30 g ethanol/day). 2. Comorbidities including: Uncontrolled hypertension (BP >=160/100 mmHg), Poorly managed diabetes mellitus (HbA1c >=8.5%), Coronary artery disease (confirmed by angiography/imaging), Severe hepatic dysfunction (Child-Pugh class B/C or ALT/AST >3×ULN). 3. Use of anti-androgen therapies, oral contraceptives, or other hormonal medications within the preceding 3 months. 4. Administration of lipid-lowering agents, insulin sensitizers, or medications with potential metabolic interference (including herbal preparations) within 90 days prior to enrollment. 5. Current pregnancy, lactation, or planned conception during the study period. 6. Non-compliance risk (assessed via Morisky Medication Adherence Scale) or active psychiatric disorders (DSM-5 diagnosed schizophrenia, bipolar disorder, or major depression). 7. Recent use (10 mg/day prednisone-equivalent for >1 week), Immunosuppressants/biologics (e.g., TNF-a inhibitors), Antibiotics (>7 consecutive days) Probiotics/prebiotics/microbiota-modulating agents. 8. Documented hypersensitivity or intolerance to metformin hydrochloride extended-release tablets, bromocriptine mesylate, or excipients. 9. Concurrent participation in other interventional trials or investigator-judged ineligibility due to competing risks/comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Full set of sex hormones;anti-Müllerian hormone;Color Doppler ultrasound of uterine appendage;Fasting blood glucose;Blood lipid set;OGTT;Fractional body fat percentage of the body;Detection OF LIVER FIBROSIS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dopamine levels;Sequencing of gut microbiota;Haptoglobin;Psychological assessment; | — |
Countries
China
Contacts
Public ContactYu Liu
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed