Clinical Science Award for poster presentation
Antonio Capalbo, laboratory Manager in Igenomix Italy, has been awarded to the first and presenting author of the best poster presentation on a clinical science topic:
- Low-degree mosaicism profiles do not provide clinically useful predictive values: interim results from the first multicenter prospective non-selection study on the transfer of mosaic embryos.
Study design, size, duration:
This is an interim analysis of a multicenter prospective non-selection study of consecutive cases performed at five IVF clinics between Sept2018 and July2019. Trophectoderm biopsies showing intermediate chromosome CNVs consistent with low mosaicism (20-50%) were blindly reported as euploid. The presence of low-grade alterations did not influence the embryo selection process, thus allowing an unbiased comparison of clinical outcomes between fully euploid and putative mosaic embryos. Ethical committee approvals were obtained at each site.
Participants/materials, setting, methods:
Consecutive patients (female age 35-44) undergoing homologous IVF cycles with blastocyst-stage PGT-A and single frozen euploid embryo transfer (SEET) were enrolled. Main exclusion condition was blastocyst of the worst morphological class. Sustained implantation rate (>20weeks) was the primary outcome measure. A sample size of 878 SEET was planned (beta=0.80; alfa=0.05) assuming 47% sustained implantation rate in the control group and 12% variation. This sample-size is also powered to detect meaningful differences in the miscarriage rate.
Main results and the role of chance:
This study evaluates transfer outcomes of 368 SEET: 197 from uniform euploid embryo group (group A), 94 from putative very-low mosaic (20-30%, group B) and 77 from the putative low mosaic group (30-50%; group C). Positive pregnancy test rate was 58.4% (95%CI=51.2%-65.3%), 60.6% (95%CI=50.0%-70.6%) and 58.4% (95%CI=46.6%-69.6%) for group A, B and C, respectively (P=NS). Biochemical pregnancy loss rate was 9.6% (95%CI=4.9%-16.5%),10.5% (95%CI=4.0%-21.5%) and 13.3% (95%CI=5.0%-26.8%) for A, B and C respectively (P=NS). Miscarriage rate was also not significantly different across groups: 12.5% (95%CI=6.8%-20.4%), 13.7% (95%CI=5.7%-26.3%) and 12.8% (95%CI=4.3%-27.4%) for A, B and C, respectively (P=NS). Sustained implantation rate was also similar: 46.2% (95%CI=39.1%-53.4%), 48,8% (95%CI=36.4%-57.4%) and 44.2% (95%CI=32.8%-55.9%), for A, B and C respectively (P=NS). Multivariate logistic regression analysis including main and potentially relevant patient and cycle factors showed slower embryo development (embryo developed to blastocysts on day 7) as the only covariate associated with sustained implantation outcome (R=0.19; 95%CI=0.05-0.7). In the multivariate analysis, after adjusting for confounding factors, the presence of a PGT-A analysis consistent with mosaicism was not significantly associated with either primary or secondary outcome measures (OR=1.001; 95%CI=0.61-1.06). When groups B and C were combined, the lack of association persisted.*
Congratulations to Dr. Capalbo and to everybody who made it possible.
*European Society of Human Reproduction and Embryology. Viewed: July 20th, 2020. P-502: Pre-selected for an award: Low-degree mosaicism profiles do not provide clinically useful predictive values: interim results from the first multicenter prospective non-selection study on the transfer of mosaic embryos. Retrieved from: https://www.eshre.eu/ESHRE2020/Virtual/Posters/Poster?pdfid=22907cf4b7014bedabd282382213c141&confcode=VIR2020&search=P-502.