Letrozole, berberine, or their combination for anovulatory infertility in women with polycystic ovary syndrome: study design of a double blind randomised controlled trial

INTERVENTION: Berberine Group:Berberine and Letrozole Placebo;Letrozole Group:Letrozole and Berberine Placebo;Berberine and Letrozole Group:Berberine and Letrozole; CONDITION: polycystic ovarian syndrome PRIMARY OUTCOME: live birth Rate; SECONDARY OUTCOME: Ovulation rate;Ongoing pregnancy rate;Multiple pregnancy rates;Miscarriage rate;Other pregnancy complications;Follicle‐stimulating hormone (FSH);Luteinising hormone (LH);Total testosterone (T);sex hormone‐binding globulin;Fasting glucose;Fasting insulin concentrations;cholesterol;triglycerides;high‐density lipoprotein cholesterol (HDL‐C);low‐density lipoprotein cholesterol (LDL‐C); INCLUSION CRITERIA: 1. Age between 20 and 40 years; 2. Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 of 3): (1) Oligo‐ovulation or anovulation; (2) Clinical and/or biochemical signs of hyperandrogenism; (3) PCOs and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen‐secreting tumours and Cushing's syndrome). 3. At least one patent tube and normal uterine cavity shown by hysterosalpingogram, hysterosalpingo‐contrast sonography or diagnostic laparoscopy within 3 years; 4. Sperm concentration 15*10^6/mL and progressive motility (grades a* and b**) >=40%. *Grade a: rapid progressive motility (sperm moving swiftly, usually in a straight line). **Grade b: slow or sluggish progressive motility (sperm may be less linear in their progression); 5. History of 1 year of infertility.