A double-blind randomized controlled trial investigating a time-lapse algorithm for selecting Day 5 blastocysts for...

Area of Science:

• Reproductive Medicine and Embryology
• In Vitro Fertilization (IVF)
• Embryo Selection Technologies

Background:

• Time-lapse monitoring of embryo development offers insights into key developmental events correlated with viability.
• Existing evidence does not conclusively support improved pregnancy rates using time-lapse technology for embryo selection.

Purpose of the Study:

• To investigate if a commercially available time-lapse algorithm for Day 5 blastocyst selection improves pregnancy rates compared to morphology alone.

Main Methods:

• A prospective, multicenter randomized controlled trial involving 776 patients undergoing fresh single embryo transfer.
• Patients were randomized to either morphology-alone selection (control) or time-lapse model selection (intervention) for Day 5 blastocysts.
• The primary outcome was the number of ongoing pregnancies, with embryologists blinded to group allocation during morphological scoring.

Main Results:

• The ongoing pregnancy rate was 47.4% in the time-lapse group versus 48.1% in the morphology-alone group (mean difference -0.7%, P=0.90).
• No statistically significant difference was observed in ongoing pregnancy rates, overall pregnancy rates, or early pregnancy loss between the groups.
• The time-lapse algorithm altered the selection of the best blastocyst in 42% of cases, but this did not translate to improved clinical outcomes.

Conclusions:

• The use of a commercial time-lapse selection model for Day 5 blastocysts does not enhance ongoing pregnancy rates compared to traditional morphology assessment.
• Current time-lapse selection algorithms, when applied to morphologically good quality blastocysts, do not offer a significant advantage in fresh IVF cycles.