Meintjes 2009.
| Methods | Prospective, randomised controlled trial, duration one year | |
| Participants | First cycle patients (n=248) undergoing routine IVF/ICSI treatment with ejaculated sperm allocated into a treatment group (n=127) or a control group (n=121).Oocyte donations are included. Exclusion criteria were: one or more previous IVF cycles without a live birth, the need to use non‐ejaculated sperm (epididymal or testicular), no oocytes retrieved or no fertilisation, PGD or cryobanking of all embryos for any reason. 18 participants were lost to follow up (originally n=248). | |
| Interventions | Gametes and embryos were cultured in an atmosphere of 5% CO2 in air (21% O2) or in 5% CO2, 5% O2, 90% N2. Embryo transfer at Day 5. |
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| Outcomes | Live births, implantation, clinical pregnancy, birth weights, and blastocyst cryopreservation | |
| Notes | Location: USA Setting: Frisco Institute for reproductive medicine Presbyterian Hospital ARTS Program No commercial funding Additional information over the study was obtained after contacting the authors Additional outcomes: Implantation rate: low oxygen: 122/247, high oxygen 95/267 Cryopreservation rate: low oxygen 99/1115, high oxygen 84/1070 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomised block design where participants were allocated to next available physician/age‐group block as they came for treatment |
| Allocation concealment (selection bias) | Low risk | Allocation concealment by using sequentially numbered, identical containers of identical drugs |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Clinicians or nurses and participants, but no scientists, were blinded for the allocation of the participants in the two study groups |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | The author provided missing data after request, follow up until delivery, loss to follow up accounted for but no ITT analysis |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned on the method section are reported in the result section |
| Other bias | Low risk | Multiple pregnancies are reported, while adhering to a multiple embryo transfer policy |