A 5-year multicentre randomized controlled trial comparing personalized, frozen and fresh blastocyst transfer in IVF

胚胎移植 活产 妊娠率 医学 胚泡移植 随机对照试验 胚胎 怀孕 妇科 胚胎培养 胚泡 单胚胎移植 产科 生物 低温保存 外科 胚胎发生 遗传学 细胞生物学
作者
Carlos Simón,Carlos José Jaramillo Gómez,Sergio Cabanillas,Iavor K. Vladimirov,G Castillon,Juan Gilés,K. Boynukalin,Necati Fındıklı,Mustafa Bahçeci,Israel Ortega,C. Vidal,Miyako Funabiki,Alexandra Izquierdo,L. Lopez,Susana Portela,Nilo Frantz,Marcos Iuri Roos Kulmann,Sagiri Taguchi,Elena Labarta,Fulvia Colucci,Shari Mackens,Xavier Alegre Santamaría,Elkin Muñoz,Saúl Barrera,Juan A. García-Velasco,Mónica Fernández,Marcos Ferrando,M. Ruíz,Ben W. Mol,Diana Valbuena
出处
期刊:Reproductive Biomedicine Online [Elsevier BV]
卷期号:41 (3): 402-415 被引量:111
标识
DOI:10.1016/j.rbmo.2020.06.002
摘要

Abstract

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.
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