Sepulveda 2011.
Methods | Prospective, randomised controlled trial | |
Participants | 100 recipients from an oocyte donation program, undergoing either IVF or ICSI were randomised into a treatment group (n=47) or a control group (n=44). 9 participants were excluded for medical reasons after randomisation. All oocytes derived from donor women. | |
Interventions | Oocytes and embryos were cultured at 5% O2 or atmospheric (20%) O2 concentration. Embryo transfer was performed on Day 5/6 of embryo development. |
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Outcomes | Clinical pregnancy rate (reported as positive beta hCG pregnancy test), multiple pregnancy rate, implantation rate, embryo development rate, cryopreservation rate, fertilisation rate, blastocyst expansion rate and MCI Grade A blastocysts rate. | |
Notes | Location: Lima, Peru Setting: Grupo PRANOR de Reproduccion Asistida Additional information regarding the study was obtained after contacting the authors No commercial funding Additional outcomes: Implantation rate: low oxygen: 38/91, high oxygen 32/87 Embryo development rate: low oxygen 205/370, high oxygen 161/385 Cryopreservation rate: low oxygen 114/370, high oxygen 74/385 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation into treatment or control group according to a computerised randomisation list |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment has not been specified |
Blinding (performance bias and detection bias) All outcomes | Low risk | Clinicians and participants were blinded for allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow up has been accounted for. No live births reported, no intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Outcomes were reported in a prespecified fashion |
Other bias | Low risk | Reporting multiple pregnancies whilst adhering to a multiple embryo transfer policy |