AI-Assisted Euploid Embryo Selection for Single-Blastocyst Transfer in Women of Advanced Maternal Age

Condition(s) studied

Investigational drug(s) / intervention(s)

AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus: AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus

AI-assisted morphological assessment using EmbryoInsights™: AI-assisted morphological assessment using EmbryoInsights™

Study summary

This single-center prospective randomized controlled study will enroll 500 infertile women aged 35 years or older who meet the criteria for fresh day-5 single-blastocyst transfer. Participants will be allocated 1:1 to AI-assisted morphological assessment using EmbryoInsights™ or AI-assisted morphological assessment combined with euploidy prediction using EmbryoInsights™ Plus. The study evaluates whether adding euploidy prediction improves ongoing pregnancy after the first fresh transfer. Secondary outcomes are clinical pregnancy, early miscarriage and live birth. Maternal and infant safety will be monitored.

Eligibility

Primary outcome measure(s)

• Ongoing pregnancy rate — From enrollment to 12 weeks of gestation ±7 days
  Ongoing pregnancy is defined as pregnancy reaching 12 weeks of gestation after transfer, with fetal cardiac activity confirmed by ultrasound. The ongoing pregnancy rate is the proportion of transfer cycles in the group that achieve ongoing pregnancy. This outcome is the sole basis for sample size estimation in this study. Assessment: ultrasound at 12 weeks of gestation ±7 days.

Trial sites (1)

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

Other trials for the same condition