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Fertil Steril. 2019 Sep 21. pii: S0015-0282(19)31979-X. doi: 10.1016/j.fertnstert.2019.07.1346. [Epub ahead of print]

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.

Author information

1
Cooper Genomics, Livingston, New Jersey; Department of Obstetrics, Gynecology, and Reproductive Science, Yale University, New Haven, Connecticut; currently at Overture Life, Barcelona, Spain.
2
Highland Park IVF Center, Fertility Centers of Illinois, Highland Park, Illinois.
3
Fertility Institute of Hawaii, Honolulu, Hawaii.
4
Oxford Fertility, Oxford, United Kingdom.
5
Olive Fertility Center, Vancouver, British Columbia, Canada.
6
IVF Michigan, Bloomfield Hills, Michigan.
7
Texas Fertility Center, Austin, Texas; Ovation Fertility, Los Angeles, California.
8
Illumina, Foster City, California.
9
School of Biosciences, University of Kent, Canterbury, United Kingdom.
10
Colorado Center for Reproductive Medicine, Lone Tree, Colorado.
11
Reprogenetics, Oxford, United Kingdom.
12
Cooper Genomics, London, United Kingdom.
13
Melbourne IVF, Melbourne, Victoria, Australia.
14
Reproductive Science Center, San Ramon, California. Electronic address: susan@susanwillman.com.

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

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