Humaidan 2004.
Methods | Randomisation: computer‐generated Allocation concealment: sealed unlabelled envelopes Blinding of participants/investigators: no Blinding of assessors: no No. randomised: 200 No. analysed: 200 Intention‐to‐treat analysis: yes Power and sample calculations described Duration of trial: 9 months, from April to December 2002 |
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Participants | Women in IVF programme undergoing transvaginal oocyte retrieval Mean age: 31 to 32 years (range 22 to 39) Cause of infertility: male, tubal disease, endometriosis, anovulation, unexplained Similar demographic and infertility characteristics at baseline |
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Interventions |
Conscious sedation and analgesia group received premedication (oral benzodiazepine 10 mg); EA group did not |
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Outcomes |
Other outcomes reported: no. of cycles, no. of embryos transferred, implantation rate |
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Notes | Denmark Single centre Skiive Hospital Funding: not stated 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 unlabelled 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 | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Low risk | Comparable demographic and infertility characteristics at baseline |