Abstract
BackgroundSubfertility is a common problem for which in vitro fertilisation (IVF) treatment is commonly recommended. Success rates following IVF are suboptimal and have remained static over the last few years. This imposes a considerable financial burden on overstretched healthcare resources. Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment. This may be either by providing undisturbed culture conditions or by improving the predictive accuracy for optimal embryo selection from a cohort of available embryos. However, the current best evidence for its effectiveness is inconclusive.MethodsThe time-lapse imaging trial is a pragmatic, multi-centre, three-arm parallel-group randomised controlled trial using re-randomisation. The primary objective of the trial is to determine if the use of TLI or undisturbed culture in IVF treatment results in a higher live birth rate when compared to current standard methods of embryo incubation and assessment. Secondary outcomes include measures of clinical efficacy and safety. The trial will randomise 1575 participants to detect an increase in live birth from 26.5 to 35.25%.DiscussionIn the absence of high-quality evidence, there is no current national guidance, recommendation or policy for the use of TLI. The use of TLI is not consistently incorporated into standard IVF care. A large, pragmatic, multi-centre, trial will provide much needed definitive evidence regarding the effectiveness of TLI. If proven to be effective, its incorporation into standard care would translate into significant clinical and economic benefits. If not, it would allow allocation of resources to more effective interventions.Trial registrationISRCTN registry ISRCTN17792989. Prospectively registered on 18 April 2018
Highlights
Background and rationale {6a} Background Subfertility is a common problem affecting 1 in 7 couples
Why this research is urgently needed Inconclusive and inadequate evidence As stated above, the current best evidence for the use of time-lapse imaging in in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) is inconclusive
A minimum of 24 h is recommended for couples to consider the trial, well-informed participants can be consented sooner than that if the local research team believes they have a good understanding of the trial and their involvement in it
Summary
Background and rationale {6a} Background Subfertility is a common problem affecting 1 in 7 couples. In vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) is a fertility treatment often recommended to these couples. It involves fertilisation of the oocytes with sperm in the laboratory to create embryos. Subfertility is a common problem for which in vitro fertilisation (IVF) treatment is commonly recommended. Success rates following IVF are suboptimal and have remained static over the last few years. Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment. This may be either by providing undisturbed culture conditions or by improving the predictive accuracy for optimal embryo selection from a cohort of available embryos. The current best evidence for its effectiveness is inconclusive
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