1. A 5-year multicentre randomized controlled trial comparing personalized, frozen and fresh blastocyst transfer in IVF
- Author
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Carlos Simón, Necati Findikli, Shari Mackens, Alexandra Izquierdo, Marcos Ferrando, Saul Guillermo Barrera, Iavor Vladimirov, Nilo Frantz, Diana Valbuena, Susana Portela, Juan A. Garcia-Velasco, Sagiri Taguchi, Marcos Iuri Roos Kulmann, Maria Ruiz, Elena Labarta, Israel Ortega, Xavier Santamaria, Ben W.J. Mol, K. Boynukalin, Sergio Cabanillas, Lourdes López, Carlos Gómez, Francisco Colucci, Mustafa Bahceci, Juan Giles, Elkin Muñoz, Manuel Tomás González Fernández, Gemma Castillon, C. Vidal, Miyako Funabiki, Faculty of Medicine and Pharmacy, Centre for Reproductive Medicine - Gynaecology, and Reproductive immunology and implantation
- Subjects
Endometrial receptivity analysis (ERA) ,Adult ,medicine.medical_specialty ,Pregnancy Rate ,endometrial receptivity ,Fresh embryo transfer (ET) ,Fertilization in Vitro ,law.invention ,Randomized controlled trial ,law ,Pregnancy ,Medicine ,Humans ,Birth Rate ,Gynecology ,Cryopreservation ,Personalized embryo transfer (PET) ,Intention-to-treat analysis ,business.industry ,Blastocyst Transfer ,Obstetrics and Gynecology ,medicine.disease ,Embryo Transfer ,Embryo transfer ,Pregnancy rate ,Treatment Outcome ,Reproductive Medicine ,Frozen embryo transfer (FET) ,embryonic structures ,Female ,Endometrial receptivity ,Window of implantation (WOI) ,Live birth ,business ,Infertility, Female ,Live Birth ,Developmental Biology - 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.
- Published
- 2020