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
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Santiago Munné, Ph.D., Brian Kaplan, M.D., John L. Frattarelli, M.D., H.C.L.D., Tim Child, M.D., Gary Nakhuda, M.D., F. Nicholas Shamma, M.D., Kaylen Silverberg, M.D., Tasha Kalista, M.A., Alan H. Handyside, Ph.D., Mandy Katz-Jaffe, M.D., Dagan Wells, Ph.D., Tony Gordon, Ph.D., Sharyn Stock-Myer, Ph.D., Susan Willman, M.D., on behalf of the show STAR Study Group
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.
Randomized controlled trial.
Women aged 25–40 years undergoing IVF with at least two blastocysts that could be biopsied.
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.
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.
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