Abstract：
BACKGROUND: Time-lapse imaging systems for embryo incubation and selection might improve outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment due to undisturbed embryo culture conditions, improved embryo selection, or both. However, the benefit remains uncertain. We aimed to evaluate the effectiveness of time-lapse imaging systems providing undisturbed culture and embryo selection, and time-lapse imaging systems providing only undisturbed culture, and compared each with standard care without time-lapse imaging.
METHODS: We conducted a multicentre, three-parallel-group, double-blind, randomised controlled trial in participants undergoing IVF or ICSI at seven IVF centres in the UK and Hong Kong. Embryologists randomly assigned participants using a web-based system, stratified by clinic in a 1:1:1 ratio to the time-lapse imaging system for undisturbed culture and embryo selection (time-lapse imaging group), time-lapse imaging system for undisturbed culture alone (undisturbed culture group), and standard care without time-lapse imaging (control group). Women were required to be aged 18-42 years and men (ie, their partners) 18 years or older. Couples had to be receiving their first, second, or third IVF or ICSI treatment and could not participate if using donor gametes. Participants and trial staff were masked to group assignment, embryologists were not. The primary outcome was live birth. We performed analyses using the intention-to-treat principle and reported the main analysis in participants with primary outcome data available (full analysis set). The trial is registered on the International Trials Registry (ISRCTN17792989) and is now closed.
RESULTS: 1575 participants were randomly assigned to treatment groups (525 participants per group) between June 21, 2018, and Sept 30, 2022. The live birth rates were 33·7% (175/520) in the time-lapse imaging group, 36·6% (189/516) in the undisturbed culture group, and 33·0% (172/522) in the standard care group. The adjusted odds ratio was 1·04 (97·5% CI 0·73 to 1·47) for time-lapse imaging arm versus control and 1·20 (0·85 to 1·70) for undisturbed culture versus control. The risk reduction for the absolute difference was 0·7 percentage points (97·5% CI -5·85 to 7·25) between the time-lapse imaging and standard care groups and 3·6 percentage points (-3·02 to 10·22) between the undisturbed culture and standard care groups. 79 serious adverse events unrelated to the trial were reported (n=28 in time-lapse imaging, n=27 in undisturbed culture, and n=24 in standard care).
CONCLUSIONS: In women undergoing IVF or ICSI treatment, the use of time-lapse imaging systems for embryo culture and selection does not significantly increase the odds of live birth compared with standard care without time-lapse imaging.
BACKGROUND: Barts Charity, Pharmasure Pharmaceuticals, Hong Kong OG Trust Fund, Hong Kong Health and Medical Research Fund, Hong Kong Matching Fund.
METHODS: We conducted a multicentre, three-parallel-group, double-blind, randomised controlled trial in participants undergoing IVF or ICSI at seven IVF centres in the UK and Hong Kong. Embryologists randomly assigned participants using a web-based system, stratified by clinic in a 1:1:1 ratio to the time-lapse imaging system for undisturbed culture and embryo selection (time-lapse imaging group), time-lapse imaging system for undisturbed culture alone (undisturbed culture group), and standard care without time-lapse imaging (control group). Women were required to be aged 18-42 years and men (ie, their partners) 18 years or older. Couples had to be receiving their first, second, or third IVF or ICSI treatment and could not participate if using donor gametes. Participants and trial staff were masked to group assignment, embryologists were not. The primary outcome was live birth. We performed analyses using the intention-to-treat principle and reported the main analysis in participants with primary outcome data available (full analysis set). The trial is registered on the International Trials Registry (ISRCTN17792989) and is now closed.
RESULTS: 1575 participants were randomly assigned to treatment groups (525 participants per group) between June 21, 2018, and Sept 30, 2022. The live birth rates were 33·7% (175/520) in the time-lapse imaging group, 36·6% (189/516) in the undisturbed culture group, and 33·0% (172/522) in the standard care group. The adjusted odds ratio was 1·04 (97·5% CI 0·73 to 1·47) for time-lapse imaging arm versus control and 1·20 (0·85 to 1·70) for undisturbed culture versus control. The risk reduction for the absolute difference was 0·7 percentage points (97·5% CI -5·85 to 7·25) between the time-lapse imaging and standard care groups and 3·6 percentage points (-3·02 to 10·22) between the undisturbed culture and standard care groups. 79 serious adverse events unrelated to the trial were reported (n=28 in time-lapse imaging, n=27 in undisturbed culture, and n=24 in standard care).
CONCLUSIONS: In women undergoing IVF or ICSI treatment, the use of time-lapse imaging systems for embryo culture and selection does not significantly increase the odds of live birth compared with standard care without time-lapse imaging.
BACKGROUND: Barts Charity, Pharmasure Pharmaceuticals, Hong Kong OG Trust Fund, Hong Kong Health and Medical Research Fund, Hong Kong Matching Fund.
摘要：
背景：用于胚胎孵化和选择的延时成像系统可能会改善体外受精（IVF）和胞浆内单精子注射（ICSI）治疗的结果，因为胚胎培养条件不受干扰，改进胚胎选择，或者两者兼而有之。然而,利益仍然不确定。我们旨在评估延时成像系统的有效性，提供不受干扰的培养和胚胎选择，和延时成像系统只提供不受干扰的文化，并将每种护理与无延时成像的标准护理进行比较。
方法：我们进行了多中心，三平行组，双盲,在英国和香港的7个IVF中心接受IVF或ICSI的参与者中进行的随机对照试验.胚胎学家使用基于网络的系统随机分配参与者，按临床以1：1：1的比例对延时成像系统进行分层，以进行不受干扰的培养和胚胎选择（延时成像组），仅用于未干扰培养的延时成像系统（未干扰培养组），和标准护理无延时成像（对照组）。要求女性年龄为18-42岁，男性为(即，他们的伴侣)18岁或以上。夫妇必须收到他们的第一个，第二,或第三次IVF或ICSI治疗，如果使用供体配子，则无法参与。参与者和试验人员被掩盖在小组分配中，胚胎学家不是。主要结果是活产。我们使用意向治疗原则进行分析，并报告了主要结果数据可用的参与者的主要分析（完整分析集）。该审判已在国际审判登记处（ISRCTN17792989）注册，现已结束。
结果：在2018年6月21日至2022年9月30日之间，1575名参与者被随机分配到治疗组（每组525名参与者）。延时成像组的活产率为33·7%(175/520)，36·6%(189/516)在未受干扰的文化组中，标准护理组为33·0%（172/522）。延时成像臂与对照组的校正比值比为1·04（97·5％CI0·73至1·47），未干扰培养与对照组的校正比值比为1·20（0·85至1·70）。延时成像和标准护理组之间绝对差异的风险降低为0·7个百分点（97·5％CI-5·85至7·25），未干扰文化和标准护理组之间为3·6个百分点（-3·02至10·22）。报告了79例与试验无关的严重不良事件（延时成像中n=28，在未受干扰的文化中n=27，在标准护理中n=24)。
结论：在接受IVF或ICSI治疗的女性中，与不进行延时成像的标准治疗相比,使用延时成像系统进行胚胎培养和选择不会显著增加活产的几率.
背景：Barts慈善机构，PharmasurePharmaceuticals,香港OG信托基金，香港卫生及医学研究基金,香港配对基金。
方法：我们进行了多中心，三平行组，双盲,在英国和香港的7个IVF中心接受IVF或ICSI的参与者中进行的随机对照试验.胚胎学家使用基于网络的系统随机分配参与者，按临床以1：1：1的比例对延时成像系统进行分层，以进行不受干扰的培养和胚胎选择（延时成像组），仅用于未干扰培养的延时成像系统（未干扰培养组），和标准护理无延时成像（对照组）。要求女性年龄为18-42岁，男性为(即，他们的伴侣)18岁或以上。夫妇必须收到他们的第一个，第二,或第三次IVF或ICSI治疗，如果使用供体配子，则无法参与。参与者和试验人员被掩盖在小组分配中，胚胎学家不是。主要结果是活产。我们使用意向治疗原则进行分析，并报告了主要结果数据可用的参与者的主要分析（完整分析集）。该审判已在国际审判登记处（ISRCTN17792989）注册，现已结束。
结果：在2018年6月21日至2022年9月30日之间，1575名参与者被随机分配到治疗组（每组525名参与者）。延时成像组的活产率为33·7%(175/520)，36·6%(189/516)在未受干扰的文化组中，标准护理组为33·0%（172/522）。延时成像臂与对照组的校正比值比为1·04（97·5％CI0·73至1·47），未干扰培养与对照组的校正比值比为1·20（0·85至1·70）。延时成像和标准护理组之间绝对差异的风险降低为0·7个百分点（97·5％CI-5·85至7·25），未干扰文化和标准护理组之间为3·6个百分点（-3·02至10·22）。报告了79例与试验无关的严重不良事件（延时成像中n=28，在未受干扰的文化中n=27，在标准护理中n=24)。
结论：在接受IVF或ICSI治疗的女性中，与不进行延时成像的标准治疗相比,使用延时成像系统进行胚胎培养和选择不会显著增加活产的几率.
背景：Barts慈善机构，PharmasurePharmaceuticals,香港OG信托基金，香港卫生及医学研究基金,香港配对基金。
