Ye 2007.
Study characteristics | ||
Methods | RCT, single centre, 40 participants, 20 months' duration | |
Participants | 40 enrolled: CHM = 20, control 1 = 10, control 2 = 10, baseline were comparable, 27.4 ± 2.7 years 40 analysed/evaluated: CHM = 20, control 1 = 10, control 2 = 10 PCOS DC: 2003 Rotterdam criteria In: PCOS and infertility and resistance to ovulation induction drugs Ex: tubal infertility, male infertility, malformation of genital organ, immunological infertility |
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Interventions | CHM: CHM periodic therapy combined with laparoscopic ovary drilling Control 1: clomiphene combined with laparoscopic ovary drilling Control 2: laparoscopic ovary drilling Duration: treatment: 6 months, follow‐up: 1 year Clomiphene: 50 mg, once a day, 5 d/m (if without efficacy, add 50 mg, maximum 150 mg/d) |
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Outcomes | LH, FSH, testosterone Ovulation rate (per woman) Pregnancy rate (per woman) |
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Notes | Laparoscopic ovary drilling: 8 to 10 holes per ovary, injected 300 mL of low molecular dextran or 4 mL of sodium hyaluronate in abdomen after surgery. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
Allocation concealment (selection bias) | Unclear risk | We contacted the study author who declined to provide related information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | We contacted the study author who declined to provide related information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | We contacted the study author who declined to provide related information |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No withdrawal or dropout was reported |
Selective reporting (reporting bias) | Unclear risk | The study protocol was unavailable |
Other bias | Low risk | No other potential risk of bias identified |
Abbreviations: CHM: Chinese herbal medicine, BMI: body mass index, PCOS: polycystic ovarian syndrome, DC: diagnosis criteria, In: inclusion criteria, Ex: exclusion criteria, HCG: human chorionic gonadotrophin, HMG: human menopausal gonadotropin, LH: luteinising hormone, FSH: follicle stimulating hormone, LUFS: luteinised unruptured follicle syndrome, OHSS: ovarian hyperstimulation syndrome, ITT: intention‐to‐treat, MPA: medroxyprogesterone acetate, EE/CPA: ethinyloestradiol cyproterone acetate, tid:three times a day, bid: twice a day, IU:International Units.