Polycystic ovary syndrome
Conditions
Interventions
A group:The first phase of the intervention required lifestyle guidance based on caloric restriction and a low carbohydrate diet accompanied by a 1000mg BID regimen with metformin.Outpatient visits we
B group:Metformin 1000mg BID was required for a normal structured diet based on caloric restriction.Outpatient visits were performed at the 4th, 8th and 12th weeks respectively.In the second phase of
Sponsors
Department of Endocrinology, The Third Affiliated Hostipal of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Aged 20 to 40 years; 2. Patients with hyperandrogenemia and meeting the diagnostic criteria for PCOS may be diagnosed with 2 of the following 3 criteria, as amended by the Rotterdam Working Group of the American Society for Reproductive Medicine (ASRM): (1) anovulation or irregular ovulation; (2) evidence of clinical or biochemical changes with elevated androgen levels (such as hirsutis, acne); (3) Ovarian enlargement, at least 12 small follicles with a diameter of 2 ~ 9mml on each side and/or unilateral or bilateral ovarian volume >= 10ml.Congenital adrenal hyperplasia and other ovarian tumors secreting testosterone were excluded.3. Body mass index (BMI) >= 24kg/m2; 4. Women who have not used contraception for more than 2 years and have not become pregnant; women who need to become pregnant but have agreed to use non-drug contraception for the last 3 months; 5. Agree to regular postnatal examinations during pregnancy and accept visitors; 6. No drugs affecting glucose and lipid metabolism or sex hormone levels have been used recently; 7. Have a normal uterus and at least one oviduct patency; 8. The semen of the spouse is normal; 9. Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. Other diseases causing ovulation dysfunction and menstrual disorders: Cushing's syndrome, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, etc.; 2. Other diseases causing high androgen levels: adrenal tumor, ovarian tumor, idiopathic hirsute, etc.; 3. Infertility caused by male weak sperm, oligospermia, semen abnormalities, sexual dysfunction, genital malformation and other factors or female reproductive tract malformation, fallopian tube factors and sexual dysfunction; 4. Take weight-loss treatment or take psychotropic drugs, hormone drugs, antihypertensive drugs, hypoglycemic drugs and other drugs that may cause weight gain or loss (such as metformin, liraglutide, taro, etc.) within the last 30 days; 5. A history of gastrointestinal disease or surgery, including intestinal obstruction, intestinal ulcers, weight loss surgery or banding surgery, gastro-intestinal anastomosis, and enterectomy; 6. Obesity caused by type diabetes, type 2 diabetes, Cushing/ Cushing syndrome and other endocrine diseases; 7. Poor control of severe hypertension, i.e., systolic blood pressure >= 180mmHg and/or diastolic blood pressure >= 110mmHg;Patients with systolic blood pressure 3 times the upper normal limit (150U/L) or total bilirubin (TB) > 34.2µmol/L;The normal upper limit of serum creatinine >. 9. Any cardiovascular, renal, hepatic, hematological, oncology, endocrine, psychiatric or rheumatic disease currently assessed by the Investigator to be unstable or severe; 10. Complicated with malignant tumors, multiple organ dysfunction and other chronic wasting diseases;Have a history of drug abuse, alcohol abuse or drug abuse in the past 6 months; 12. The investigator determines that protocol adherence is not possible or that there are patients with a serious physical or mental illness that could affect effectiveness or safety; 13. Engage in heavy manual labor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pregnancy rate;pregnancy outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| weight;Body mess index;waistline;glycometabolism;change in blood fat;change in the function of islets;change in sex hormones;inflammatory indications;change in blood pressure;change in adipokines;change in intestinal flora; | — |
Countries
China
Contacts
Public ContactZhang Ying
Department of Endocrinology, The Third Affiliated Hostipal of Guangzhou Medical University
Outcome results
None listed