Smith 2006.
Methods | Randomised controlled trial in fertility clinic in Australia | |
Participants | 228 randomised, 36 excluded: 110 in treatment group and 118 in control group. The average age of the control group (± SD) was 35.9 years (± 4.7) versus 36.1 years (± 4.8) in the study group; there were no differences in the number of previous treatment cycles, BMI, duration of subfertility. |
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Interventions | All women had 3 sessions: day 9 of stimulation, immediately before ET, and immediately after ET. For the sham acupuncture group a sham needle was used close to but not on the treatment point | |
Outcomes | Clinical pregnancy rates | |
Assisted conception protocols | Protocol breakdown not provided | |
Notes | After 3rd session, 24 in treatment group and 10 in control group guessed their allocation group correctly | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | ‘randomization was in balanced, variable blocks of random size prepared by a researcher not involved in the trial’. |
Allocation concealment (selection bias) | Unclear risk | Not stated specifically |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Control groups had placebo needles (Streitberger) although after the 3rd session, 24 in the treatment group and 10 in the control group guessed their allocation group correctly. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 228 subjects were randomized. 36 women had to be withdrawn (15%). |
Selective reporting (reporting bias) | Unclear risk | LBR data not reported. |
Other bias | Low risk | None known |