Abstract：
OBJECTIVE: Does artificial shrinkage before fresh blastocyst transfer improve clinical pregnancy rates in IVF?
METHODS: In this monocentric prospective, randomized, double-blind, controlled pilot study, 150 couples undergoing fresh single-blastocyst transfer were randomized between 20 May 2018 and 22 February 2022. In the artificial shrinkage group (AS group), a single laser pulse was directed to the cellular junction of the trophectoderm on the opposite side of the inner cell mass in each blastocyst. IVF outcomes were clinical pregnancy, multiple pregnancy and live birth rates. Cell-free DNA (cfDNA) concentration was also measured by quantitative real-time PCR in the blastocyst culture medium.
RESULTS: In total, 142 couples underwent fresh single-blastocyst transfer: control group, no artificial shrinkage, n = 47; and AS group, artificial shrinkage, n = 95; An intention-to-treat (ITT) analysis was employed. After a reassessment and the exclusion of patients with major protocol deviations, 139 couples underwent fresh single-blastocyst transfer under optimal conditions: control group, n = 47; and AS group, n = 92; a per-protocol analysis was used here. The clinical and laboratory characteristics were not significantly different between the groups. The clinical pregnancy rate was similar in the control and AS groups (ITT: 48.9% versus 49.5%, P = 0.97; per protocol: 48.94% versus 51.1%, P = 0.89). The multiple pregnancy rate and the live birth rate were also similar between the groups. No significant differences in gestational age, birthweight or proportion of male/female newborns were observed. The concentration of cfDNA in the blastocyst culture medium was not associated with IVF outcome.
CONCLUSIONS: Large-scale randomized controlled trials are required to confirm these preliminary results.
METHODS: In this monocentric prospective, randomized, double-blind, controlled pilot study, 150 couples undergoing fresh single-blastocyst transfer were randomized between 20 May 2018 and 22 February 2022. In the artificial shrinkage group (AS group), a single laser pulse was directed to the cellular junction of the trophectoderm on the opposite side of the inner cell mass in each blastocyst. IVF outcomes were clinical pregnancy, multiple pregnancy and live birth rates. Cell-free DNA (cfDNA) concentration was also measured by quantitative real-time PCR in the blastocyst culture medium.
RESULTS: In total, 142 couples underwent fresh single-blastocyst transfer: control group, no artificial shrinkage, n = 47; and AS group, artificial shrinkage, n = 95; An intention-to-treat (ITT) analysis was employed. After a reassessment and the exclusion of patients with major protocol deviations, 139 couples underwent fresh single-blastocyst transfer under optimal conditions: control group, n = 47; and AS group, n = 92; a per-protocol analysis was used here. The clinical and laboratory characteristics were not significantly different between the groups. The clinical pregnancy rate was similar in the control and AS groups (ITT: 48.9% versus 49.5%, P = 0.97; per protocol: 48.94% versus 51.1%, P = 0.89). The multiple pregnancy rate and the live birth rate were also similar between the groups. No significant differences in gestational age, birthweight or proportion of male/female newborns were observed. The concentration of cfDNA in the blastocyst culture medium was not associated with IVF outcome.
CONCLUSIONS: Large-scale randomized controlled trials are required to confirm these preliminary results.
摘要：
目的：新鲜囊胚移植前人工收缩能提高IVF的临床妊娠率吗？
方法：在本单心前瞻性研究中，随机化，双盲,对照试验研究，在2018年5月20日至2022年2月22日期间，随机分配了150对接受新鲜单囊胚移植的夫妇。在人工收缩组(AS组)中，单个激光脉冲指向每个胚泡内细胞团相对侧的滋养外胚层的细胞连接处。IVF结果是临床妊娠，多胎妊娠和活产率。也通过定量实时PCR在胚泡培养基中测量无细胞DNA(cfDNA)浓度。
结果：总计，142对夫妇接受了新鲜的单囊胚移植：对照组，没有人工收缩，n=47；AS组，人工收缩,n=95；采用意向治疗(ITT)分析。在重新评估并排除有主要方案偏差的患者后，139对夫妇在最佳条件下进行了新鲜的单囊胚移植：对照组，n=47；AS组，n=92;此处使用符合方案的分析。两组之间的临床和实验室特征没有显着差异。对照组和AS组的临床妊娠率相似（ITT：48.9%对49.5%，P=0.97；每个方案：48.94%对51.1%，P=0.89）。两组之间的多胎妊娠率和活产率也相似。胎龄无显著差异,观察出生体重或男女新生儿的比例。囊胚培养基中cfDNA的浓度与IVF结果无关。
结论：需要大规模随机对照试验来证实这些初步结果。
方法：在本单心前瞻性研究中，随机化，双盲,对照试验研究，在2018年5月20日至2022年2月22日期间，随机分配了150对接受新鲜单囊胚移植的夫妇。在人工收缩组(AS组)中，单个激光脉冲指向每个胚泡内细胞团相对侧的滋养外胚层的细胞连接处。IVF结果是临床妊娠，多胎妊娠和活产率。也通过定量实时PCR在胚泡培养基中测量无细胞DNA(cfDNA)浓度。
结果：总计，142对夫妇接受了新鲜的单囊胚移植：对照组，没有人工收缩，n=47；AS组，人工收缩,n=95；采用意向治疗(ITT)分析。在重新评估并排除有主要方案偏差的患者后，139对夫妇在最佳条件下进行了新鲜的单囊胚移植：对照组，n=47；AS组，n=92;此处使用符合方案的分析。两组之间的临床和实验室特征没有显着差异。对照组和AS组的临床妊娠率相似（ITT：48.9%对49.5%，P=0.97；每个方案：48.94%对51.1%，P=0.89）。两组之间的多胎妊娠率和活产率也相似。胎龄无显著差异,观察出生体重或男女新生儿的比例。囊胚培养基中cfDNA的浓度与IVF结果无关。
结论：需要大规模随机对照试验来证实这些初步结果。
