Live Birth With or Without Preimplantation Genetic Testing for Aneuploidy

To optimize live birth rate per transfer in in vitro fertilization (IVF), morphologic score based on visualization and genetic status based on preimplantation genetic testing for aneuploidy (PGT-A) are used to select the highest quality embryos. Although some studies suggest an increased live birth rate among women of advanced maternal age, it is less clear whether PGT-A in women with good prognosis for live birth experience a similar benefit. This randomized, controlled noninferiority trial aimed to compare the cumulative live birth rate after PGT-A on the basis of a combination of morphologic criteria and next-generation sequencing with the rate after conventional IVF on the basis of morphologic criteria alone. Between July 2017 and June 2018, couples diagnosed with subfertility, planning on undergoing their first IVF cycle, and considered to have a good prognosis for live birth (age 20 to 37 years with 3 or more good-quality blastocysts) were recruited at 14 academic fertility centers in China. In the PGT-A group, a euploid blastocyst was chosen for transfer, and in the conventional-IVF group, a blastocyst was chosen on the basis of morphology. Transfers were repeated in the case of failure so long as therewere embryos of suitable quality. The primary study outcome was cumulative live birth rate within 1 year of randomization. The noninferiority margin for comparing conventional IVF with PGT-A equated to 7 percentage points greater for PGT-A. A total of 1212 women underwent randomization with 606 allocated to each group and 1146 completing the protocol. Of the 1809 embryos that underwent PGT-A, 1262 (69.8%) were euploid, 311 (17.2%) were aneuploid, 211 (11.7%) were mosaic, and 25 (1.4%) were questionable. The intention-to-treat analysis revealed a cumulative live birth rate of 77.2% in the PGT-A group and 81.8% in the conventional IVF group (absolute difference, -4.6 percentage points; 95% confidence interval, -9.2 to 0.0; P < 0.001), meeting the criteria for noninferiority. The frequencies of cumulative clinical pregnancy loss were 8.7% in the PGT-A group and 12.6% in the conventional-IVF group (rate ratio, 0.69; 95% confidence interval, 0.49-0.98). This large randomized, controlled trial of women with good prognosis for live birth and undergoing IVF found that, compared with PGT-A, conventional IVF resulted in a cumulative live birth rate that was noninferior and higher, although carried a slightly higher rate of clinical pregnancy loss.