polycystic ovary syndrome
Conditions
Interventions
Intervention Group:TCM treatment + probiotics
Sponsors
Shenzhen Maternal and Child Health Center
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-40 years; 2. fulfilling the western medical diagnostic criteria of polycystic ovary syndrome (PCOS); According to the diagnostic criteria for PCOS in reproductive age and perimenopause in the 2018 edition of the Chinese Diagnostic and Treatment Guidelines for Polycystic Ovary Syndrome (PCOS) 1) Irregular menstruation or menstrual disorders (menstrual cycles of >35 days or 90 days) and then 1 of the following 2 items are met: (ii) Clinical hyperandrogenism or hyperandrogenemia; Clinical hyperandrogenemia: sFG = 3 score; Biochemical hyperandrogenemia: T > 2.6 nmol/L with free testosterone = 6.0 pg/ml. (iii) Ovarian ultrasound showing PCOM; The number of follicles with diameter of 2-9 mm in unilateral or bilateral ovaries =12 and/or ovarian volume =10 ml; 3. stop using any medication that affects menstruation and ovulation promotion one week before enrollment;. For example: birth control pills hormonal drugs letrozole clomiphene. 4. Comply with the PCOS Chinese medicine syndrome classification; 5. sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. not meeting the western medical diagnostic criteria for PCOS or without TCM syndrome; 2. exposure to systemic antibiotics within the last month; 3. taking endocrine-affecting drugs at the time of enrollment; 1) contraceptive pills 2) hormone drugs 3) Ovulation stimulating drugs 4) Gonadotropins follicle stimulating hormone gonadotropin-releasing hormone and its analogs gonadotropin-releasing hormone agonists (disruption injections) chorionic gonadotropin bromocriptine; 4. BMI = 28; 5. other causes of abnormal ovulation and hyperandrogenemia e.g. hyperprolactinemia and thyroid disorders congenital adrenocortical hyperplasia Cushing's syndrome androgen-secreting tumors exogenous androgen application; 6. tests suggesting non-benign endometrial lesions uterine malformations submucous fibroids malformations of the reproductive tract congenital gonadal hypoplasia diseases; and 7. Combined cardiovascular cerebrovascular hepatic renal hematopoietic and other serious primary diseases as well as other endocrine disorders (severe thyroid disease adrenal gland dysfunction) mental illnesses; 8. those who are participating in other clinical trials 9. history of gastrointestinal surgery in the last year; 10. heavy smoking or alcoholism inflammatory bowel disease irritable bowel syndrome autoimmune diseases malignant tumors and other diseases affecting the intestinal tract.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| menstrual cycle frequency;average menstrual cycle days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Acne score;ovarian function;inflammatory factors;waist-to-hip ratio;Fecal microbiota structure;BMI;Sex hormone levels;Glycolipid metabolism markers;Body hair score; | — |
Countries
China
Contacts
Public ContactYan Ning
Shenzhen Maternal and Child Health Center
Outcome results
None listed