Embryo incubation and assessment by time-lapse system versus conventional incubators in Chinese women with diminished ovarian re serve undergoing IVF/ICSI : a study protocol for a randomized controlled trial
Abstract Background: Time-lapse imaging system (TLS) is a newly developed non-invasive embryo assessment system. Compared with conventional incubators, it provides stable culture condition and consistent observation of embryo development, thereby improving embryo quality and selection. In theory, these benefits could improve clinical outcomes of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Although this system has been routinely used in many IVF centers globally, it remains unclear if the TLS results in higher cumulative live birth rate and high-quality evidence is warranted. The purpose of this study is to compare the effectiveness of the TLS with conventional incubators in infertile diminished ovarian reserve (DOR) patients. Methods: This study is a double-blind randomized controlled clinical trial (1:1 treatment ratio of TLS vs. conventional incubator). A total of 730 DOR patients undergoing the first or second cycle of IVF or ICSI will be enrolled and randomized into two parallel groups. Participants in group A will undergo embryo culture and selection in the TLS, and participants in group B will undergo embryo culture in the conventional incubators and embryo selection by the morphological characteristics. The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomization. This study is powered to detect an absolute difference of 10% (35% vs 25%) at the significance level of 0.05 and 80% statistical power based on a two-sided test. Discussion: The results of this study will provide evidence for the efficacy and safety of time-lapse system compared with conventional incubators in patients with DOR undergoing IVF/ICSI. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027746. Registered on 24 Nov 2019.