Park 2015.
Methods | Study: single‐centre RCT, couples undergoing ICSI Country: Sweden Cause and length of infertility: male‐factor infertility was present in > 99% of participants in both study arms. Female‐factor infertility was present in approximately 20% of participants in both study arms. Duration of infertility was approximately 2.8 years in both study arms. Oocytes: autologous Embryo transfer: single embryo transfer at day 2 Informed consent: yes Total study duration: May 2010 to February 2014 (3 years, 9 months) Funding sources: Sahlgrenska Academy, Sahlgrenska University Hospital, LUA/ALF 70940, Ferring Research Infertility and Gynecology Grant, Hjalmar Svensson Grant, Unisense Fertilitech: Unisense provided the EmbryoScope free of charge during the study. |
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Participants | 364 couples with infertility undergoing their first IVF cycle with ICSI. 1 embryo (in a few cases 2 embryos, N = 12) of good quality, or in some cycles of less good quality (N = 27), was transferred on day 2, and supernumerary good‐quality embryos were frozen. 241 couples were randomised to TLS, and 124 were randomised to conventional incubation. 1 couple was excluded from the TLS arm as they had been randomised twice. Age: (years, mean ± SD, TLS versus conventional incubation): 31.8 ± 4.3 versus 31.8 ± 4.1; P = 0.90 BMI: (kg/m2, mean ± SD, TLS versus conventional incubation): 24.4 ± 3.9 versus 24.3 ± 4.0; P = 0.70 Ethnicity: not reported Inclusion criteria:
Exclusion criteria:
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Interventions | TLS with conventional morphological assessment of still TLS images (intervention) Conventional incubation and assessment (control) |
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Outcomes | Clinical pregnancy rate per couple randomised Ongoing pregnancy rate defined as presence of the foetal heart at >= 8 weeks' gestation Miscarriage per couple randomised |
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Notes | Live‐birth, stillbirth, and clinical pregnancy data obtained on communication with study authors. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was undertaken using (quote): "a web‐based randomization programme and all the patients’ oocytes were allocated to culture in either a conventional incubator or in a closed system, in proportion 1:2" |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was carried out by the embryologist after oocyte retrieval". On communication with the authors, they clarified that the embryologist undertaking the randomisation may have also undertaken the embryo assessment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The patients as well as the treating physician and the person performing the statistical analyses were blinded to which type of procedure was used until the outcome of transfer (pregnant versus not pregnant) was known". It was not possible to blind the embryologists, therefore performance bias deemed at high risk. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The patients as well as the treating physician and the person performing the statistical analyses were blinded to which type of procedure was used until the outcome of transfer (pregnant versus not pregnant) was known. Embryologists were not possible to blind" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 woman was excluded from analysis in the intervention arm, as she was randomised twice. No women were excluded from the control arm. No dropouts. |
Selective reporting (reporting bias) | Low risk | All predetermined outcomes were reported. |
Other bias | Low risk | None detected. |