Ma HX 2009.
Study characteristics | ||
Methods | RCT, single centre, 170 participants, 4 years' duration | |
Participants | 170 enrolled: CHM = 85, control = 85, baseline was comparable 165 analysed/evaluated: CHM = 85, control = 80 (5 withdrawals for personal reasons) Age (years): CHM: 28.4 ± 5.3, control: 27.9 ± 4.9 Infertility time (years): CHM: 3.8 ± 2.1, control: 3.6 ± 1.9 PCOS DC: 2003 Rotterdam criteria In: PCOS and infertility Ex: other endocrinology diseases, hormone user in the last 3 months, male infertility, tubal infertility |
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Interventions | CHM: CHM combined with ethinyloestradiol cyproterone acetate (EE/CPA) and ovulation induction Control: EE/CPA followed by ovulation induction CHM: basic formula in EE/CPA therapy duration, CHM periodic therapy in ovulation induction phase (gui shao di huang soup in 5th to 14th day of menstrual cycle, tao hong si wu soup in 12th to 16th day of menstrual cycle, shou tai pellet after ovulation) EE/CPA: from 5th day of menstrual cycle, 1 pill, once a day, 21 days/m, treated for 3 cycles and then ovulation induction ovulation induction: clomiphene (from 5th day of menstrual cycle, 50 mg, once a day, 5 days/m), 5000 to 10,000 IU HCG was injected when dominant follicle was present, ovulation induction until pregnancy but no more than 3 cycles Duration: treatment: no more than 6 menstrual cycles, follow‐up time was unclear. |
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Outcomes | Ovulation rate (per cycle) Pregnancy rate (per woman) Miscarriage rate |
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Notes | Ethinyloestradiol cyproterone acetate: Germany Schering company, batch number: G20040104 | |
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 | Low risk | No ITT analysis. The analysis rate was 97.1% (165/170) |
Selective reporting (reporting bias) | Unclear risk | The study protocol was unavailable |
Other bias | Low risk | No other potential risk of bias identified |