Carlos Simón1, Carlos Gómez2, Sergio Cabanillas3, Iavor Vladimirov4, Gemma Castillón5, Juan Giles3, Kubra Boynukalin6, Necati Findikli6, Mustafa Bahçeci6, Israel Ortega7, Carmina Vidal3, Miyako Funabiki8, Alexandra Izquierdo9, Lourdes López9, Susana Portela10, Nilo Frantz11, Marcos Kulmann11, Sagiri Taguchi8, Elena Labarta3, Francisco Colucci12, Shari Mackens13, Xavier Santamaría5, Elkin Muñoz10, Saúl Barrera14, Juan Antonio García-Velasco7, Manuel Fernández15, Marcos Ferrando16, María Ruiz2, Ben W Mol17, Diana Valbuena18. 1. Department of Pediatrics, Obstetrics and Gynecology, University of Valencia, Valencia 46010, Spain; Igenomix Foundation-INCLIVA, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain; IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain. Electronic address: carlos.simon@uv.es. 2. Igenomix SL, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain. 3. IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain. 4. SBALAGRM-Sofia, 5 Baku St, Sofia 1756, Bulgaria. 5. IVI-RMA Barcelona, Ronda General Mitre 14 Barcelona 08017, Spain. 6. Bahçeci Health Group-Fulya IVF Centre, Hakki Yeten Cad, 11 Kat 3, Terrace Fulya Istanbul 34365, Turkey. 7. IVI-RMA Madrid, Av Del Talgo 68, Aravaca Madrid 28023, Spain. 8. Oak Clinic Japan, 2-7-9 Tamade-Nishi, Nishinari-ku Osaka 557-0045, Japan. 9. ProcreaTec, Calle Manuel de Falla 6-8, Madrid 28036, Spain. 10. IVI-RMA Vigo, Plaza Francisco Fernández del Riego 7, Vigo 36203, Spain. 11. Nilo Frantz Reproductive Medicine, Av Dr Nilo Peçanha 1221 - 10° andar, Boa Vista Porto Alegre, Brazil. 12. Centro de Infertilidade e Medicina Fetal do Norte Fluminense, R Barão da Lagoa Dourada 409 - Centro, Campos dos Goytacazes Rio de Janeiro 28035-210, Brazil. 13. Department of Reproductive Medicine, Universitair Ziekenhuis Brussel, 101 Laarbeeklaan, Jette Brussels 1090, Belgium. 14. IVI-RMA Panama, Calle 50 & Calle 57 Este, Panama City Panamá 07185. 15. IVI-RMA Sevilla, Av República Argentina 58 Sevilla 41011, Spain; Departamento de Cirugía, Universidad de Sevilla, Avda. Sánchez Pizjuan S/N Sevilla 41009, Spain; Departamento de Biología Molecular e Ingeniería Bioquímica, Universidad Pablo de Olavide Sevilla 41013, Spain. 16. IVI-RMA Bilbao, Leioa Paseo Landabarri 1Vizcaya 48940, Spain. 17. Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168, Australia. 18. Igenomix Foundation-INCLIVA, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain; Igenomix SL, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain.
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 transferin 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.
RCT Entities:
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 infertilepatients 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.
Authors: Abha Maheshwari; Vasha Bari; Jennifer L Bell; Siladitya Bhattacharya; Priya Bhide; Ursula Bowler; Daniel Brison; Tim Child; Huey Yi Chong; Ying Cheong; Christina Cole; Arri Coomarasamy; Rachel Cutting; Fiona Goodgame; Pollyanna Hardy; Haitham Hamoda; Edmund Juszczak; Yacoub Khalaf; Andrew King; Jennifer J Kurinczuk; Stuart Lavery; Clare Lewis-Jones; Louise Linsell; Nick Macklon; Raj Mathur; David Murray; Jyotsna Pundir; Nick Raine-Fenning; Madhurima Rajkohwa; Lynne Robinson; Graham Scotland; Kayleigh Stanbury; Stephen Troup Journal: Health Technol Assess Date: 2022-05 Impact factor: 4.106