Abstract：
OBJECTIVE: To evaluate whether laser-mediated assisted hatching (AH) performed on vitrified/warmed blastocysts before embryo transfer can improve live birth rate.
METHODS: The \"pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN)\" is a 2-center comparative study with a parallel randomized controlled design.
METHODS: University hospital.
METHODS: Participants were recruited between September 2018 and November 2021. They were aged 18-39 years, underwent nondonor in vitro fertilization cycles, and were scheduled for elective single embryo transfer with vitrified/warmed blastocysts. Those with uterine abnormalities, body mass index of >35 kg/m2, severe male factor infertility, or performing preimplantation genetic testing were excluded.
METHODS: Assisted hatching was performed using a 1,480 nm diode laser, removing approximately one-third of the zona pellucida with continuous 0.2 ms pulses applied from the 1-5 o\'clock positions.
METHODS: The primary outcome was the live birth rate. Secondary end points included clinical pregnancy, miscarriage, multiple pregnancies, preterm births, obstetric and neonatal complications, and congenital anomalies.
RESULTS: Overall, 698 participants met the inclusion criteria and were randomized: 352 patients were assigned to the AH arm and 346 to the control arm. Of the participants, 105 (29.8%) and 101 (29.2%), respectively, achieved a live birth after treatment. The relative risk of live birth in patients with vitrified/warmed blastocysts treated with AH was 1.02 (95% confidence interval, 0.86-1.19). Exploratory subgroup analyses for women\'s age, recruiting centers, indications for in vitro fertilization, method of insemination, blastocyst quality, and days of blastocyst development failed to highlight any clinical situation that could benefit from AH in thawed blastocysts.
CONCLUSIONS: In patients undergoing frozen embryo transfer with vitrified/warmed blastocysts, laser AH does not improve the live birth rate. Further studies are required to rule out milder but potentially interesting benefits in specific subgroups of patients.
BACKGROUND: ClinicalTrials.gov: NCT03623659.
METHODS: The \"pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN)\" is a 2-center comparative study with a parallel randomized controlled design.
METHODS: University hospital.
METHODS: Participants were recruited between September 2018 and November 2021. They were aged 18-39 years, underwent nondonor in vitro fertilization cycles, and were scheduled for elective single embryo transfer with vitrified/warmed blastocysts. Those with uterine abnormalities, body mass index of >35 kg/m2, severe male factor infertility, or performing preimplantation genetic testing were excluded.
METHODS: Assisted hatching was performed using a 1,480 nm diode laser, removing approximately one-third of the zona pellucida with continuous 0.2 ms pulses applied from the 1-5 o\'clock positions.
METHODS: The primary outcome was the live birth rate. Secondary end points included clinical pregnancy, miscarriage, multiple pregnancies, preterm births, obstetric and neonatal complications, and congenital anomalies.
RESULTS: Overall, 698 participants met the inclusion criteria and were randomized: 352 patients were assigned to the AH arm and 346 to the control arm. Of the participants, 105 (29.8%) and 101 (29.2%), respectively, achieved a live birth after treatment. The relative risk of live birth in patients with vitrified/warmed blastocysts treated with AH was 1.02 (95% confidence interval, 0.86-1.19). Exploratory subgroup analyses for women\'s age, recruiting centers, indications for in vitro fertilization, method of insemination, blastocyst quality, and days of blastocyst development failed to highlight any clinical situation that could benefit from AH in thawed blastocysts.
CONCLUSIONS: In patients undergoing frozen embryo transfer with vitrified/warmed blastocysts, laser AH does not improve the live birth rate. Further studies are required to rule out milder but potentially interesting benefits in specific subgroups of patients.
BACKGROUND: ClinicalTrials.gov: NCT03623659.
摘要：
目的：评估在胚胎移植前对玻璃化/温热胚泡进行激光介导的辅助孵化（AH）是否可以提高活产率。
方法：“通过胚泡的辅助孵化（ALADDIN）去除pArtiaLzonApelluciDa”是一项平行随机对照设计的2中心比较研究。
方法：参与者在2018年9月至2021年11月之间招募。他们年龄在18到39岁之间,接受非供体IVF周期，并计划使用玻璃化/温热的胚泡进行选择性单胚胎移植。那些有子宫异常的人，BMI>35kg/m2，重度男性因素不育，或进行植入前基因检测被排除.
方法：使用1480nm二极管激光器进行辅助孵化，从1到5个时钟位置施加连续的0.2ms脉冲，去除大约三分之一的透明带。
方法：主要结局是活产率。次要终点包括临床妊娠，流产,多胎妊娠,早产,产科和新生儿并发症，和先天性异常。
结果：总体而言，698名参与者符合纳入标准，并被随机分组：352名患者被分配到AH组，346名患者被分配到对照组。一百零五（29.8％）和101（29.2％）参与者在治疗后实现了活产，分别(p=0.87)。用AH治疗的玻璃化/温热胚泡患者活产的相对风险为1.02(95CI:0.86-1.19)。女性年龄的探索性亚组分析，招募中心,IVF的适应症，授精方法,囊胚质量,囊胚发育的天数未能突显任何可能从解冻囊胚AH中受益的临床情况。
结论：在接受玻璃化/温热胚泡冷冻胚胎移植的患者中，激光AH并不能提高活产率。需要进一步的研究来排除在特定患者亚组中更温和但潜在有趣的益处。
方法：“通过胚泡的辅助孵化（ALADDIN）去除pArtiaLzonApelluciDa”是一项平行随机对照设计的2中心比较研究。
方法：参与者在2018年9月至2021年11月之间招募。他们年龄在18到39岁之间,接受非供体IVF周期，并计划使用玻璃化/温热的胚泡进行选择性单胚胎移植。那些有子宫异常的人，BMI>35kg/m2，重度男性因素不育，或进行植入前基因检测被排除.
方法：使用1480nm二极管激光器进行辅助孵化，从1到5个时钟位置施加连续的0.2ms脉冲，去除大约三分之一的透明带。
方法：主要结局是活产率。次要终点包括临床妊娠，流产,多胎妊娠,早产,产科和新生儿并发症，和先天性异常。
结果：总体而言，698名参与者符合纳入标准，并被随机分组：352名患者被分配到AH组，346名患者被分配到对照组。一百零五（29.8％）和101（29.2％）参与者在治疗后实现了活产，分别(p=0.87)。用AH治疗的玻璃化/温热胚泡患者活产的相对风险为1.02(95CI:0.86-1.19)。女性年龄的探索性亚组分析，招募中心,IVF的适应症，授精方法,囊胚质量,囊胚发育的天数未能突显任何可能从解冻囊胚AH中受益的临床情况。
结论：在接受玻璃化/温热胚泡冷冻胚胎移植的患者中，激光AH并不能提高活产率。需要进一步的研究来排除在特定患者亚组中更温和但潜在有趣的益处。
