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

doi:10.1016/j.fertnstert.2019.07.1346

Assisted Reproduction Add-Ons and Adjuncts

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

Munné S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S, STAR Study Group

Published December 2019 Fertil Steril

DOI 10.1016/j.fertnstert.2019.07.1346 PMID 31551155

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.

Patients

Women aged 25-40 years undergoing IVF with at least two blastocysts that could be biopsied.

Interventions

Randomization for single frozen-thawed embryo transfer with embryo selection based on PGT-A euploid status versus morphology.

Main Outcome Measures

Ongoing pregnancy rate (OPR) at 20 weeks' gestation per embryo transfer.

Results

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.

Conclusions

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.

Trial Registration

NCT02268786.

Topics

Assisted Reproduction › Add-Ons and Adjuncts › Preimplantation Genetic Testing · Genetics and Immunology › Reproductive Genetics › Chromosomal Abnormalities

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

S Munné, B Kaplan, Jack Frattarelli, J Frattarelli, Timothy Child, T Child, G Nakhuda, K Silverberg, T Kalista, A Handyside, M Katz-Jaffe, D Wells, Anthony Gordon, T Gordon, S Stock-Myer, Sue Willman, S Willman

PMID 31551155 31551155 DOI 10.1016/j.fertnstert.2019.07.1346 10.1016/j.fertnstert.2019.07.1346 Munné et al. 2019, Munné 2019

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

Abstract

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