A 5-year Multicenter Randomized Controlled Trial of In Vitro Fertilization with Personalized Blastocyst Transfer versus Frozen or Fresh Transfer.

ABSTRACT RESEARCH QUESTION Is there any difference in the clinical performance of personalized embryo transfer (pET) guided by the endometrial receptivity analysis (ERA) versus frozen embryo transfer (FET) or fresh embryo transfer (ET) in infertile patients undergoing IVF? DESIGN Multicenter, open-label RCT including 458 patients ≤ 37 years undergoing IVF with blastocyst transfer at their first appointment that were randomized to pET guided by ERA, FET or ET in 16 reproductive clinics. RESULTS Clinical outcomes by intention-to-treat (ITT) analysis were comparable, except that cumulative pregnancy rate (CPR) was significantly higher in the pET group (93.6%) compared to FET (79.7%) (p=0.0005), and ET (80.7%) (p=0.0013). Analysis per protocol (PP) demonstrates that LB rates at the first embryo transfer were 56.2% in pET versus 42.4% in FET (p=0.09), and 45.7% in ET (p=0.17). Cumulative LB rates after 12 months were 71.2% in pET versus 55.4% in FET (p=0.04), and 48.9% in ET (p=0.003). Pregnancy rates at the first embryo transfer in pET, FET and ET arms were 72.5% versus 54.3% (p=0.01) and 58.5% (p=0.05), respectively. Implantation rates at the 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 In this RCT, despite an unexpected 50% patient drop-out rate compared to the 30% initially planned, PP analysis demonstrates statistically significant improvement in pregnancy, implantation and cumulative LB rates in pET compared to FET and ET arms, indicating the potential utility of pET guided by the ERA test at the first appointment.