Research question

Does clinical performance of personalized embryo transfer (PET) guided by endometrial receptivity analysis (ERA) differ from frozen embryo transfer (FET) or fresh embryo transfer in infertile patients undergoing IVF?

Design

Multicentre, open-label randomized controlled trial; 458 patients aged 37 years or younger undergoing IVF with blastocyst transfer at first appointment were randomized to PET guided by ERA, FET or fresh embryo transfer in 16 reproductive clinics.

Results

Clinical outcomes by intention-to-treat analysis were comparable, but cumulative pregnancy rate was significantly higher in the PET (93.6%) compared with FET (79.7%) (P = 0.0005) and fresh embryo transfer groups (80.7%) (P = 0.0013). Analysis per protocol demonstrates that live birth rates at first embryo transfer were 56.2% in PET versus 42.4% in FET (P = 0.09), and 45.7% in fresh embryo transfer groups (P = 0.17). Cumulative live birth rates after 12 months were 71.2% in PET versus 55.4% in FET (P = 0.04), and 48.9% in fresh embryo transfer (P = 0.003). Pregnancy rates at the first embryo transfer in PET, FET and fresh embryo transfer arms were 72.5% versus 54.3% (P = 0.01) and 58.5% (P = 0.05), respectively. Implantation rates at first embryo transfer were 57.3% versus 43.2% (P = 0.03), and 38.6% (P = 0.004), respectively. Obstetrical outcomes, type of delivery and neonatal outcomes were similar in all groups.

Conclusions

Despite 50% of patients dropping out compared with 30% initially planned, per protocol analysis demonstrates statistically significant improvement in pregnancy, implantation and cumulative live birth rates in PET compared with FET and fresh embryo transfer arms, indicating the potential utility of PET guided by the ERA test at the first appointment.

中文翻译：

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一项为期 5 年的多中心随机对照试验，比较 IVF 中个性化、冷冻和新鲜囊胚移植。

研究问题

子宫内膜容受性分析 (ERA) 指导下的个性化胚胎移植 (PET) 的临床表现与接受 IVF 的不育患者的冷冻胚胎移植 (FET) 或新鲜胚胎移植有何不同？

设计

多中心、开放标签随机对照试验；在 16 个生殖诊所，458 名 37 岁或以下接受 IVF 和囊胚移植的患者随机接受 ERA、FET 或新鲜胚胎移植指导的 PET。

结果

意向治疗分析的临床结果具有可比性，但与 FET (79.7%) ( P  = 0.0005) 和新鲜胚胎移植组 ( P  = 80.7%)相比，PET (93.6%) 的累积妊娠率显着更高( P = 0.0013）。每个方案的分析表明，PET 中首次胚胎移植时的活产率为 56.2%，而 FET 为 42.4% ( P  = 0.09)，新鲜胚胎移植组为 45.7% ( P  = 0.17)。12 个月后的累积活产率在 PET 中为 71.2%，在 FET 中为 55.4% ( P  = 0.04)，在新鲜胚胎移植中为 48.9% ( P  = 0.003)。PET、FET 和新鲜胚胎移植组首次胚胎移植时的妊娠率为 72.5% 与 54.3%（P = 0.01) 和 58.5% ( P  = 0.05)，分别。第一次胚胎移植时的植入率分别为 57.3% 和 43.2% ( P  = 0.03) 和 38.6% ( P  = 0.004)。所有组的产科结局、分娩类型和新生儿结局相似。

结论

尽管与最初计划的 30% 相比，50% 的患者退出，但根据协议分析表明，与 FET 和新鲜胚胎移植臂相比，PET 的妊娠、植入和累积活产率有统计学意义的改善，表明 PET 的潜在效用由第一次预约时进行 ERA 测试。