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. 2021 Jun 4;2021(6):CD007535. doi: 10.1002/14651858.CD007535.pub4

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
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.
Outcomes Ovulation rate (per cycle)
Pregnancy rate (per woman)
Miscarriage rate
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