Lok 2002.
Methods | Randomisation: computer‐generated Allocation concealment: sealed opaque envelopes Blinding of participants/investigators: no Blinding of assessors: no No. randomised: 110 No. analysed: 106 Intention‐to‐treat analysis: no Power and sample calculations described Duration of trial: not stated |
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Participants | Women undergoing transvaginal oocyte retrieval Mean age: 33 to 35 years Cause of infertility: tubal disease, male factor, endometriosis, anovulation, unexplained Women in control group 2 years younger than women in intervention group (P = 0.01); other baseline characteristics similar |
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Interventions |
No premedication in either group |
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Outcomes |
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Notes | China Single centre Chinese University of Hong Kong Funding: not stated Loss to follow‐up (N = 4) in intervention group due to pump failure (n = 1) and personal reasons (n = 3) Definition of pregnancy not documented |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Adequate: sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not possible owing to the nature of the interventions Blinding of assessors not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Four lost to follow‐up (3%) |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Unclear risk | Significant differences in age between the 2 groups Comparable infertility characteristics at baseline |