NCT03503877

Media, Morphokinetics, and Mosaicism

Aneuploidy Rates and Morphokinetic Parameters in Sibling Embryos Cultured in Distinct Culture Media

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

Embryonic aneuploidy is the underlying etiology for the majority of failed implantation and miscarriage. Preimplantation genetic screening (PGS) with transfer of a euploid embryo has been advocated as a strategy for increasing live birth rates with a single embryo transfer. Culturing embryos to the blastocyst stage for trophectoderm biopsy is a requirement for PGS. Several commercially-available single-step embryonic culture media with varying composition have been established for use in the IVF laboratory. Early reports have suggested differences in clinical outcomes, such as aneuploidy and miscarriage rates, with distinct culture media currently in standard use. However, there have been no clinical trials demonstrating the superiority of any one commercially-available culture media formulation. As a result, clinics use media with varying composition based upon familiarity and cost.

Conditions

• Embryonic Mosaicism
• Embryo Culture Media
• Embryo Morphokinetics
• Infertility

Interventions

Type	Name	Description
DEVICE	EmbryoScope Plus	All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
OTHER	GLOBAL MEDIA	Embryos will be cultured in GLOBAL media
OTHER	SAGE MEDIA	Embryos will be cultured in SAGE media

Timeline

• Start date: 2018-02-14
• Primary completion: 2019-11-28
• Completion: 2019-11-28
• First posted: 2018-04-20
• Last updated: 2022-12-14
• Results posted: 2022-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study