Carmen Rubio1, José Bellver2, Lorena Rodrigo3, Gema Castillón4, Alfredo Guillén5, Carmina Vidal6, Juan Giles6, Marcos Ferrando7, Sergio Cabanillas6, José Remohí2, Antonio Pellicer8, Carlos Simón9. 1. Igenomix Valencia/INCLIVA, Valencia, Spain. Electronic address: carmen.rubio@igenomix.com. 2. Instituto Valenciano de Infertilidad, Valencia University, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology, School of Medicine, Valencia University, Valencia, Spain. 3. Igenomix Valencia/INCLIVA, Valencia, Spain. 4. Instituto Valenciano de Infertilidad, Barcelona, Spain. 5. Instituto Valenciano de Infertilidad, Madrid, Universidad Juan Carlos I, Madrid, Spain. 6. Instituto Valenciano de Infertilidad, Valencia University, Valencia, Spain. 7. Instituto Valenciano de Infertilidad, Bilbao, Spain. 8. Instituto Valenciano de Infertilidad, Valencia University, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology, School of Medicine, Valencia University, Valencia, Spain; Instituto de Investigación Sanitaria La Fe, Valencia, Spain. 9. Igenomix Valencia/INCLIVA, Valencia, Spain; Instituto Valenciano de Infertilidad, Valencia University, Valencia, Spain; Department of Pediatrics, Obstetrics and Gynecology, School of Medicine, Valencia University, Valencia, Spain.
Abstract
OBJECTIVE: To determine the clinical value of preimplantation genetic diagnosis for aneuploidy screening (PGD-A) in women of advanced maternal age (AMA; between 38 and 41 years). DESIGN: This was a multicenter, randomized trial with two arms: a PGD-A group with blastocyst transfer, and a control group with blastocyst transfer without PGD-A. SETTING:Private reproductive centers. PATIENT(S): A total of 326 recruited patients fit the inclusion criteria, and 205 completed the study (100 in the PGD-A group and 105 in the control group). INTERVENTION(S): Day-3 embryo biopsy, array comparative genomic hybridization, blastocyst transfer, and vitrification. MAIN OUTCOME MEASURE(S): Primary outcomes were delivery and live birth rates in the first transfer and cumulative outcome rates. RESULT(S): The PGD-A group exhibited significantly fewer ETs (68.0% vs. 90.5% for control) and lower miscarriage rates (2.7% vs. 39.0% for control). Delivery rate after the first transfer attempt was significantly higher in the PGD-A group per transfer (52.9% vs 24.2%) and per patient (36.0% vs. 21.9%). No significant differences were observed in the cumulative delivery rates per patient 6 months after closing the study. However, the mean number of ETs needed per live birth was lower in the PGD-A group compared with the control group (1.8 vs. 3.7), as was the time to pregnancy (7.7 vs. 14.9 weeks). CONCLUSION(S): Preimplantation genetic diagnosis for aneuploidy screening is superior compared with controls not only in clinical outcome at the first ET but also in dramatically decreasing miscarriage rates and shortening the time to pregnancy.
RCT Entities:
OBJECTIVE: To determine the clinical value of preimplantation genetic diagnosis for aneuploidy screening (PGD-A) in women of advanced maternal age (AMA; between 38 and 41 years). DESIGN: This was a multicenter, randomized trial with two arms: a PGD-A group with blastocyst transfer, and a control group with blastocyst transfer without PGD-A. SETTING: Private reproductive centers. PATIENT(S): A total of 326 recruited patients fit the inclusion criteria, and 205 completed the study (100 in the PGD-A group and 105 in the control group). INTERVENTION(S): Day-3 embryo biopsy, array comparative genomic hybridization, blastocyst transfer, and vitrification. MAIN OUTCOME MEASURE(S): Primary outcomes were delivery and live birth rates in the first transfer and cumulative outcome rates. RESULT(S): The PGD-A group exhibited significantly fewer ETs (68.0% vs. 90.5% for control) and lower miscarriage rates (2.7% vs. 39.0% for control). Delivery rate after the first transfer attempt was significantly higher in the PGD-A group per transfer (52.9% vs 24.2%) and per patient (36.0% vs. 21.9%). No significant differences were observed in the cumulative delivery rates per patient 6 months after closing the study. However, the mean number of ETs needed per live birth was lower in the PGD-A group compared with the control group (1.8 vs. 3.7), as was the time to pregnancy (7.7 vs. 14.9 weeks). CONCLUSION(S): Preimplantation genetic diagnosis for aneuploidy screening is superior compared with controls not only in clinical outcome at the first ET but also in dramatically decreasing miscarriage rates and shortening the time to pregnancy.
Authors: E Mateu-Brull; L Rodrigo; V Peinado; A Mercader; I Campos-Galindo; F Bronet; S García-Herrero; M Florensa; M Milán; C Rubio Journal: J Assist Reprod Genet Date: 2019-11-06 Impact factor: 3.412