Intent to treat analysis reveals significantly improved clinical outcomes with aneuploidy testing in an age-matched population

Abstract

Preimplantation genetic testing for aneuploidy (PGT-A) has been proposed as an improved embryo selection strategy to decrease pregnancy loss and increase live birth rates for infertility patients undergoing in vitro fertilization (IVF). In an intent to treat analysis, we investigated clinical outcomes with PGT-A, compared to patients who have freeze-all blastocyst cycles with embryo selection based on morphology alone. Prospective cohort age-matched study. Infertility couples were identified during their IVF consult as intent to treat with either a freeze-all blastocyst cycle or IVF with PGT-A. Female patients were maternally age-matched between the two treatment groups (mean 32.5 ±3.7 years; n=46 per group). For the ‘Freeze All’ group, blastocysts were vitrified using the Cryotop method on either day 5 (D5) or day 6 (D6) of development. In contrast, for the ‘PGT-A’ group, prior to vitrification, D5 or D6 blastocysts were biopsied and analyzed for chromosome numeration using the VeriSeq™ platform (Illumina). Standard protocols for a hormone replacement frozen embryo transfer (FET) were utilized, with either blastocyst morphology alone (Freeze All) or euploid (PGT-A) embryo selection. Primary outcomes measured included implantation (fetal heart tone), ongoing clinical pregnancy, miscarriage, and live birth rates. Statistical analysis included Student’s t-test and Fisher’s exact test where appropriate, significance at P<0.05. In each treatment group, 46 retrievals were performed with no significant differences in number of oocytes retrieved, fertilized or number of usable blastocysts between the two treatment groups (P≥0.05; ns). Two retrievals (4.4%) resulted in no fertilization and four (8.7%) with no blastocyst development in the Freeze All group, while one (2.2%) resulted in no fertilization and four (8.7%) with no blastocyst development in the PGT-A group (P≥0.05; ns). Additionally, following PGT-A, two (4.4%) cycles ended with all aneuploid blastocysts. Remaining patients underwent FET with significant clinical improvements for primary outcomes measured in the PGT-A group (P<0.05; Table 1). From the prospective of intent to treat analysis, at the time a clinical decision is made to proceed with IVF therapy, the inclusion of PGT-A resulted in significantly improved clinical outcomes in a younger maternally age-matched population. This data reflects that embryo selection incorporating PGT-A should be considered for infertility patients undergoing IVF.Table 1FET OutcomesFreeze All (n=40)PGT-A (n=39)Implantation Rate (fetal heart tone)48.2%78.9%*Ongoing Clinical Pregnancy Rate60%84.6%*Miscarriage Rate16.7%6.1%Live Birth Rate per FET50%79.5%*Live Birth Rate per Intent to Treat43.5%65.2%**P<0.05 Open table in a new tab