Study Comparing DaVitri Semi-automated Vitrification to Manual Process for Egg Freezing and Pregnancy Outcomes in Women Undergoing IVF

What this Trial Is About

Researchers are evaluating the Overture Semi-Automated Vitrification System DaVitri compared to the standard manual process for freezing human oocytes. This study involves female egg donors and recipients undergoing in-vitro fertilization IVF with egg donation. The goal is to compare clinical pregnancy rates after embryo transfer using oocytes preserved by either method. The study builds on a previous trial focusing on blastocyst development as a primary endpoint. Egg donors will provide consent before egg retrieval. Retrieved mature oocytes will be divided into groups and randomly assigned to either the DaVitri system or manual vitrification for freezing. Both groups use the same preservation media. After warming, oocytes will be fertilized by ICSI and embryos cultured to blastocyst stage. Recipients will then receive a single embryo transfer from either the DaVitri or manual group as randomly assigned. Participants will be monitored for clinical pregnancy confirmed by ultrasound at 6-7 weeks after embryo transfer. Secondary outcomes include oocyte survival after warming, fertilization rates, embryo quality, blastocyst formation, implantation, ongoing pregnancy, congenital abnormalities, and delivery success. The study follows recipients through pregnancy up to delivery, with data collected over several months from enrollment.

Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System ("DaVitri") to Standard Manual Process for Clinical Pregnancy Outcomes