Obstetrics and Gynaecology Department, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Infertility Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Fertil Steril. 2024 Jul;122(1):106-113. doi: 10.1016/j.fertnstert.2024.02.010. Epub 2024 Feb 9.
To evaluate whether laser-mediated assisted hatching (AH) performed on vitrified/warmed blastocysts before embryo transfer can improve live birth rate.
The "pArtiaL zonA pelluciDa removal by assisteD hatchINg of blastocysts (ALADDIN)" is a 2-center comparative study with a parallel randomized controlled design.
University hospital.
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/m, severe male factor infertility, or performing preimplantation genetic testing were excluded.
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.
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.
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.
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.
ClinicalTrials.gov: NCT03623659.
评估在胚胎移植前对玻璃化/解冻的囊胚进行激光辅助孵化（AH）是否可以提高活产率。
“部分透明带去除辅助孵化囊胚（ALADDIN）”是一项 2 中心的比较研究，采用平行随机对照设计。
大学医院。
参与者于 2018 年 9 月至 2021 年 11 月期间招募。他们年龄在 18-39 岁之间，接受非捐赠者体外受精周期，并计划进行选择性单胚胎移植，移植对象为玻璃化/解冻的囊胚。那些有子宫异常、体重指数>35kg/m2、严重男性因素不育或进行植入前遗传学检测的患者被排除在外。
使用 1480nm 二极管激光进行辅助孵化，从 1 点到 5 点位置以连续 0.2ms 脉冲去除约三分之一的透明带。
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以及先天性异常。
共有 698 名符合纳入标准的患者被随机分组：352 名患者被分配到 AH 组，346 名患者被分配到对照组。在接受治疗后，分别有 105 名（29.8%）和 101 名（29.2%）患者活产。玻璃化/解冻囊胚接受 AH 治疗的患者活产的相对风险为 1.02（95%置信区间，0.86-1.19）。对女性年龄、招募中心、体外受精的适应证、授精方法、囊胚质量和囊胚发育天数进行的探索性亚组分析未能突出任何可以从解冻囊胚的 AH 中获益的临床情况。
在接受冷冻胚胎移植的玻璃化/解冻囊胚患者中，激光辅助孵化不能提高活产率。需要进一步研究以排除在特定患者亚组中可能存在的更轻微但潜在有趣的益处。
ClinicalTrials.gov：NCT03623659。
