TY - JOUR
T1 - TILT
T2 - Time-Lapse Imaging Trial-a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment
AU - Bhide, Priya
AU - Srikantharajah, Arasaratnam
AU - Lanz, Doris
AU - Dodds, Julie
AU - Collins, Bonnie
AU - Zamora, Javier
AU - Chan, David
AU - Thangaratinam, Shakila
AU - Khan, Khalid S
PY - 2020/7/1
Y1 - 2020/7/1
N2 - BACKGROUND: 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. 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.METHODS: The 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%.DISCUSSION: In 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 REGISTRATION: ISRCTN registry ISRCTN17792989 . Prospectively registered on 18 April 2018.
AB - BACKGROUND: 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. 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.METHODS: The 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%.DISCUSSION: In 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 REGISTRATION: ISRCTN registry ISRCTN17792989 . Prospectively registered on 18 April 2018.
KW - Embryo Culture Techniques
KW - Embryonic Development/physiology
KW - Female
KW - Fertilization in Vitro
KW - Humans
KW - Live Birth/epidemiology
KW - Multicenter Studies as Topic
KW - Pragmatic Clinical Trials as Topic
KW - Pregnancy
KW - Pregnancy Rate
KW - Time-Lapse Imaging/methods
KW - Treatment Outcome
U2 - 10.1186/s13063-020-04537-2
DO - 10.1186/s13063-020-04537-2
M3 - Article
C2 - 32611445
SN - 1745-6215
VL - 21
SP - 600
JO - Trials
JF - Trials
IS - 1
ER -