Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial
Santiago Munné, Brian Kaplan, John L Frattarelli, Tim Child, Gary Nakhuda, F Nicholas Shamma, Kaylen Silverberg, Tasha Kalista, Alan H Handyside, Mandy Katz-Jaffe, Dagan Wells, Tony Gordon, Sharyn Stock-Myer, Susan Willman, STAR Study Group, Brian Acacio, Stuart Lavery, Anna Carby, Robert Boostanfar, Robert Forman, Mark Sedler, Anthea Jackson, Keith Jordan, William Schoolcraft, Mandy Katz-Jaffe, Susanna McReynolds, Vicki Schnell, Randall Loy, Samuel Chantilis, Lowell Ku, Brian Kaplan, John Frattarelli, Arlene Morales, H Randall Craig, Mark Perloe, Craig Witz, Wei-Hua Wang, John Wilcox, John Norian, Stephanie Marshall Thompson, Serena Chen, John Garrisi, Renee Walmsley, Robert Mendola, F Nicholas Shamma, Samuel Pang, Denny Sakkas, Kristin Rooney, Rita Sneeringer, Michael Glassner, Sharyn Stock-Myer, Leeanda Wilton, Mirjana Martic, Peter Coleman, Stephanie Shepley, Gary Nakhuda, Tim Child, Ginny Mounce, Tracey Griffiths, Ronald F Feinberg, Keith Blauer, Brett Reggio, Rachel Rhinehart, William Ziegler, Hina Ahmed, Scott Kratka, Susan Willman, Evan Rosenbluth, Kristen Ivani, Angela Thyer, Kaylen Silverberg, Tamara Minter, Charles Miller, Mathias Gysler, Pauline Saunders, Robert Casper, Deirdre Conway, Tony Gordon, Mark Hughes, Michael Large, Joshua Blazek, Santiago Munné, Dagan Wells, Elpida Fragouli, Samer Alfarawati, Santiago Munné, Brian Kaplan, John L Frattarelli, Tim Child, Gary Nakhuda, F Nicholas Shamma, Kaylen Silverberg, Tasha Kalista, Alan H Handyside, Mandy Katz-Jaffe, Dagan Wells, Tony Gordon, Sharyn Stock-Myer, Susan Willman, STAR Study Group, Brian Acacio, Stuart Lavery, Anna Carby, Robert Boostanfar, Robert Forman, Mark Sedler, Anthea Jackson, Keith Jordan, William Schoolcraft, Mandy Katz-Jaffe, Susanna McReynolds, Vicki Schnell, Randall Loy, Samuel Chantilis, Lowell Ku, Brian Kaplan, John Frattarelli, Arlene Morales, H Randall Craig, Mark Perloe, Craig Witz, Wei-Hua Wang, John Wilcox, John Norian, Stephanie Marshall Thompson, Serena Chen, John Garrisi, Renee Walmsley, Robert Mendola, F Nicholas Shamma, Samuel Pang, Denny Sakkas, Kristin Rooney, Rita Sneeringer, Michael Glassner, Sharyn Stock-Myer, Leeanda Wilton, Mirjana Martic, Peter Coleman, Stephanie Shepley, Gary Nakhuda, Tim Child, Ginny Mounce, Tracey Griffiths, Ronald F Feinberg, Keith Blauer, Brett Reggio, Rachel Rhinehart, William Ziegler, Hina Ahmed, Scott Kratka, Susan Willman, Evan Rosenbluth, Kristen Ivani, Angela Thyer, Kaylen Silverberg, Tamara Minter, Charles Miller, Mathias Gysler, Pauline Saunders, Robert Casper, Deirdre Conway, Tony Gordon, Mark Hughes, Michael Large, Joshua Blazek, Santiago Munné, Dagan Wells, Elpida Fragouli, Samer Alfarawati
Abstract
Objective: To evaluate the benefit of next-generation sequencing (NGS)-based preimplantation genetic testing for aneuploidy (PGT-A) for embryo selection in frozen-thawed embryo transfer.
Design: Randomized controlled trial.
Setting: Not applicable.
Patient(s): Women aged 25-40 years undergoing IVF with at least two blastocysts that could be biopsied.
Intervention(s): Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology.
Main outcome measure(s): Ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer.
Result(s): A total of 661 women (average age 33.7 ± 3.6 years) were randomized to PGT-A (n = 330) or morphology alone (n = 331). The OPR was equivalent between the two arms, with no significant difference per embryo transfer (50% [137/274] vs. 46% [143/313]) or per intention to treat (ITT) at randomization (41.8% [138/330] vs. 43.5% [144/331]). Post hoc analysis of women aged 35-40 years showed a significant increase in OPR per embryo transfer (51% [62/122] vs. 37% [54/145]) but not per ITT.
Conclusion(s): PGT-A did not improve overall pregnancy outcomes in all women, as analyzed per embryo transfer or per ITT. There was a significant increase in OPR per embryo transfer with the use of PGT-A in the subgroup of women aged 35-40 years who had two or more embryos that could be biopsied, but this was not significant when analyzed by ITT.
Clinical trial registration number: NCT02268786.
Keywords: IVF; frozen-thawed embryo transfer; next-generation sequencing; preimplantation genetic testing; single-embryo transfer.
Copyright © 2019 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Source: PubMed