Goodman 2016.
Methods | Study: completed single‐centre RCT of couples with infertility undergoing IVF Country: USA Cause and length of infertility: infertility diagnosis included unexplained, ovulatory dysfunction, male factor, tubal factor, low ovarian reserve, AMA, endometriosis, mixed factors, and other. Mean length of infertility in both groups was approximately 31.5 months. Oocytes: autologous oocytes Embryo transfer: between 1 and 3 fresh embryos on day 3 or day 5. The number of embryos transferred was based on published ASRM committee guidance and patient preferences. Informed consent: yes Total study duration: March 2014 to May 2015 (14 months) Funding sources: quote: "no external funding for the study" |
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Participants | A total of 300 couples with infertility undergoing IVF with autologous oocytes were recruited: 150 randomised to TLS selection (cell‐tracking algorithm of TLS utilised) and 150 randomised to conventional selection (TLS with conventional once‐daily morphologic embryo screening). 5 couples did not receive the allocated intervention: 2 from the time‐lapse selection arm due to lack of fertilisation, and 3 from the conventional selection group, 2 due to no fertilisation and 1 due to no sperm. Age (years, mean ± SD, time‐lapse selection versus conventional selection): 33.6 ± 4.0 versus 33.2 ± 3.9 BMI (kg/m2, mean ± SD, time‐lapse selection versus conventional selection): 26.3 ± 6.7 versus 26.9 ± 7.4 Ethnicity: combination of white, black, Asian, Middle Eastern, and other Inclusion criteria:
Exclusion criteria:
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Interventions | TLS utilising cell‐tracking algorithm (intervention) TLS with conventional assessment of morphological parameters from still TLS images (control) |
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Outcomes | Clinical pregnancy rate per couple randomised (defined by the presence of foetal cardiac activity on transvaginal ultrasonography at >= 6 weeks gestational age)Miscarriage per couple randomised | |
Notes | Data on clinical pregnancy from women excluded following randomisation and miscarriage data were obtained following communication with the authors. Live‐birth and stillbirth data were requested, but this information was not available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomized 1:1 to conventional embryo selection versus Embryoscope time‐lapse morphokinetic selection with the use of a computer‐generated random number sequence" |
Allocation concealment (selection bias) | Low risk | Quote: "The list was housed in the laboratory, where it was accessible only by research personnel not involved with the recruitment of patients" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Patients, physicians and staff, and sonographers were blinded to how embryos were selected". However, the embryologist who was responsible for deciding on day of embryo transfer (day 3 or day 5) was unblinded, therefore deemed high risk. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "sonographers were blinded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | We have obtained all relevant data from women who were excluded postrandomisation from the authors. |
Selective reporting (reporting bias) | Low risk | We confirmed with the authors that all outcomes the study set out to assess were published. |
Other bias | Low risk | No other sources of bias identified. |