Hagemann 2010.
Study characteristics | ||
Methods | Randomised single‐centre cross‐over trial | |
Participants | 103 women in the United States younger than 38 years of age with any embryo with zona pellucida thickness > 13 μm and more than 2 previously failed IVF cycles Mean age: 32.1 years in hatched group, 31.2 in unhatched group | |
Interventions | AH performed by acidic Tyrode's solution AH: 49 women Control: 54 women |
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Outcomes | Clinical intrauterine pregnancy rate, implantation rate, spontaneous pregnancy loss, live birth rate | |
Notes | Power calculation: study states it has inadequate power. Study as ultimately performed had sufficient statistical power to identify only a 30% absolute effect size with alpha = 0.05 and beta = 0.80
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) | High risk | Randomisation was performed by IVF lab staff by drawing 1 of 200 opaque envelopes from a box |
Allocation concealment (selection bias) | Unclear risk | Opaque envelopes drawn but not numbered |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study arm to which participants belonged was blinded to caregivers, with the exception of IVF embryologists, as well as to participants |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
Selective reporting (reporting bias) | High risk | Live birth reported (but results not included in this study, as results were given only for both cycles combined, not for just the first cycle; these are the data we are using). No other evidence of reporting bias |
Other bias | Low risk | None identified |