Nada 2018.
| Study characteristics | ||
| Methods | Randomisation – computer‐generated list of random numbers but block randomisation with block size of 4 – allocation concealment unclear Participant blinding unclear Conducted at 2 private centres in Cairo and Beni Suif Participants not blinded or unclear Full article |
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| Participants | 326 women Only high‐quality Day 3 embryos were used (defined as 8 to 10 cells on Day 3, < 15% fragmentation, absence of multi‐nucleation, symmetrical blastomeres, absence of ZP dysmorphism, absence of perivitelline space granularity, colourless cytoplasm with moderate granulation, no inclusions) |
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| Interventions | LAH to dissolve 25% to 30% of ZP with 3 adjacent pulses of the laser LAH – 163 patients (5 with cycle cancellation) – 158 remaining No LAH – 163 patients (13 with cycle cancellation) remaining LAH just before transfer (no further information given) |
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| Outcomes | Live birth rate Clinical pregnancy (defined as serum hCG > 20 IU/L and TVS confirming GS with pulsating fetal pole 4 weeks post transfer or 6 weeks post menstrual) Implantation rate (per embryo transferred, defined as number of GS present on TV USS 4 weeks after transfer/number of embryos transferred) |
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| Notes | 2 to 3 embryos transferred per cycle Sample size calculation performed (presumed pregnancy rate of 57% and 40% in control) ITT analysis Mean age: LAH 31.27, control 32.64 Study registered on Pan African Clinical Trials Registry: PACTR201602001467322 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers |
| Allocation concealment (selection bias) | Unclear risk | Block randomisation with block size of 4 with 1:1 ratio of LAH vs control but no further information |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Assessor blinded to allocation No information about participants or other personnel |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 18 participants excluded after randomisation due to cycle cancellation – no reasons for cancellation given |
| Selective reporting (reporting bias) | High risk | Multiple pregnancy rate given with denominator per embryo transferred |
| Other bias | Unclear risk | No information Although registered on Pan African Clinical Trials Registry, no primary or secondary outcomes stated in trial information |