Validation of the PMT-BC Test: Mass Spectral Analysis of Spent Blastocyst Media for Prediction of IVF Blastocyst-Embryo Implantation Potential

Globally the average success rate per transfer of IVF Blastocyst Embryo is less than 30%. The preimplantation metabolomic test for blastocyst-embryo competence – PMT-BC was developed from Ai/ML analysis of MALDI-ToF MS spectra from spent blastocyst culture media (SBM), for biomarkers of implantation and blastocyst first trimester embryonic competence. Here the Seven point BMT-BC scale was tested against a cohort of 1,840 SBM MALDI-ToF metabolite mass spectra from day 5+ in vitro cultured IVF blastocyst-embryos. Selection of samples, from a database of 12,000 SBM spectra, was solely on the basis of samples at, day 5 (predominantly) or 6,7 of In vitro culture, single embryo transfer and from a single IVF clinical centre. It was not biased by knowledge of maternal age, aneuploid status, fresh or frozen transfer or transfer outcome. Examined with respect to identifying implantation and viable competent IVF Blastocyst-Embryo’s to transfer; it correctly identified 90.3% of low Gardner grading & disintegrating blastocysts, and 89.9% of implantation but embryonic incompetent blastocysts (and subsequent anembryonic IVF pregnancies), prior to transfer. All scoring a PMT-BC of less than 3, these are IVF-Blastocyst with low potential success; whilst higher PMT-Scores correlated with implantation and viable IVF pregnancies. Combining viability markers with its scoring of probability of implantation markers, the selection of day5 (6 or 7) IVF-Blastocyst-Embryo for transfer based on BMT-BC test scores greater than 3 would have increased the transferred success rate of viable IVF Blastocyst-Embryo in the cohort by 50-100%.