NCT06419127

Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation Sequencing

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Gattaca Genomics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to discern if there is a relationship between timelapse imagery of human oocytes/embryos and PGT results. Embryos of patients that are undergoing PGT will be placed into a timelapse incubator. The data obtained by the timelapse incubator will be used in conjunction with the PGT data to determine any relationships.

Detailed description

Timelapse imagery (TLI) is a multifaceted technology being utilized within the in vitro fertilization (IVF) space. With this technology it is possible to have a live, continuous video of embryo development from fertilization to implantation. During this live evaluation multiple datapoints can be extrapolated and used to determine embryo viability. Another technology used in the IVF space is preimplantation genetic testing for aneuploidy (PGT-A). With this technology, individual cells from the embryo are removed, amplified, and the chromosomal content of the cells is analyzed by next generation sequencing (NGS)-based technology, allowing the chromosomal content of the embryos to be determined prior to embryo transfer. To date, no one has combined the data from both tools to try to advance the IVF field. Gattaca Genomics is proposing utilizing the data obtained from TLI, in conjunction with the data obtained from PGT-A, to create a computer model that can accurately predict which embryos will lead to a successful outcome during IVF.

Conditions

• Infertility, Female
• Infertility, Male
• Infertility
• IVF
• Aneuploidy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Timelapse incubation and PGT	Patients will have their embryos cultured in a timelapse incubator and their PGT results will be compared to the data collected during timelapse incubation.

Timeline

• Start date: 2025-01-01
• Primary completion: 2031-06-01
• Completion: 2033-06-01
• First posted: 2024-05-17
• Last updated: 2026-01-29

Locations

1 site across 1 country: United States