Preimplantation Genetic Testing for Aneuploidy Does Not Improve Cumulative IVF Live-Birth Rates
This multicentre RCT randomised 1,212 subfertile women with three or more good-quality blastocysts to PGT-A by next-generation sequencing or conventional IVF with morphological selection. Cumulative live-birth rates after up to three transfers were 77.2% with PGT-A versus 81.8% with conventional IVF, meeting prespecified noninferiority criteria for conventional IVF. Clinical pregnancy loss was lower with PGT-A (8.7% vs 12.6%), but these findings challenge the routine use of NGS-based aneuploidy screening in women with multiple good-quality embryos.
The original study
Live Birth with or without Preimplantation Genetic Testing for Aneuploidy.
- Authors
- Yan J, Qin Y, Zhao H, Sun Y, Gong F, Li R, et al.
- Journal
- The New England journal of medicine
- Type
- Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- PMID
- 34818479
Original abstract
BACKGROUND: Embryo selection with preimplantation genetic testing for aneuploidy (PGT-A) may improve pregnancy outcomes after initial embryo transfer. However, it remains uncertain whether PGT-A improves the cumulative live-birth rate as compared with conventional in vitro fertilization (IVF). METHODS: In this multicenter, randomized, controlled trial, we randomly assigned subfertile women with three or more good-quality blastocysts to undergo either PGT-A or conventional IVF; all the women were between 20 and 37 years of age. Three blastocysts were screened by next-generation sequencing in the PGT-A group or were chosen by morphologic criteria in the conventional-IVF group and then were successively transferred one by one. The primary outcome was the cumulative live-birth rate after up to three embryo-transfer procedures within 1 year after randomization. We hypothesized that the use of PGT-A would result in a cumulative live-birth rate that was no more than 7 percentage points higher than the rate after conventional IVF, which would constitute the noninferiority margin for conventional IVF as compared with PGT-A. RESULTS: A total of 1212 patients underwent randomization, and 606 were assigned to each trial group. Live births occurred in 468 women (77.2%) in the PGT-A group and in 496 (81.8%) in the conventional-IVF group (absolute difference, -4.6 percentage points; 95% confidence interval [CI], -9.2 to -0.0; P<0.001). The cumulative frequency of clinical pregnancy loss was 8.7% and 12.6%, respectively (absolute difference, -3.9 percentage points; 95% CI, -7.5 to -0.2). The incidences of obstetrical or neonatal complications and other adverse events were similar in the two groups. CONCLUSIONS: Among women with three or more good-quality blastocysts, conventional IVF resulted in a cumulative live-birth rate that was noninferior to the rate with PGT-A. (Funded by the National Natural Science Foundation of China and others; ClinicalTrials.gov number, NCT03118141.).