Hellebaut 1996.
Methods | Randomised, single centre trial | |
Participants | 120 women from Belgium undergoing IVF or ICSI Mean age: control group 30.8 (3.9); AH group 30.9 (4.3) years | |
Interventions | AH (mechanical; complete zona breach hole; 48 hours egg retrieval to AH; 0.2 hours AH to transfer) versus no AH AH: 60 women randomised, 168 embryos transferred Control: 60 women randomised, 162 embryos transferred | |
Outcomes | Implantation, clinical pregnancy, live birth, miscarriage, ectopic pregnancy | |
Notes | Attempted to contact author about this study. A reply including much useful additional information was received
No. of embryos transferred: AH 2.8 (0.6); Control 2.7 (0.6) Unclear if power calculation performed ITT analysis unclear Published as full paper |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By computer on day of transfer |
Allocation concealment (selection bias) | High risk | Allocation concealment inadequate |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants not blinded Assessor not blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT analysis unclear |
Selective reporting (reporting bias) | Low risk | Live birth reported. Authors responded to requests for details. No other evidence of bias, all outcomes stated were reported |