NCT03687697

Comparison of Global, G-TL, & Cornell Media

A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized clinical trial to compare the Global commercial single step media to 1) G-TL (Vitrolife), 2) Weill Cornell's single step and sequential steps media, which all support human embryo development in the laboratory using the Vitrolife Time-Lapse system. The main goal of the study is to identify the best culture medium for optimal embryo development.

Detailed description

Culture media are used to culture embryos in order to support their development in the laboratory. New media are being introduced to the market. Clinical studies have shown that the use of the single-step Global medium for culture of human embryos from the zygote stage to the blastocyst stage has resulted in better in-vitro development than a variety of sequential media system. Global is a FDA approved commercial single-step medium for all embryo culture from Day 0 to the blastocyst stage. G-TL (Time-Lapse) is a FDA approved commercial single-step medium from Vitrolife. It was developed to be used with time-lapse devices as a continuous embryo culture medium from Day 0 to Day 5/6. C3 is Cornell's in house made single-step buffered medium for embryo culture from oocyte fertilization to blastocyst stage used as standard of care. C1/C2 is Cornell's in house made buffered sequential medium otherwise known as multi step medium, use to culture embryos for development. It is formulated to meet the embryos requirements at two specific stages of development but require removal of the dish from the incubator to physically exchange the culture media surrounding the embryos. This medium will be the control.

Conditions

• Infertility

Interventions

Type	Name	Description
BIOLOGICAL	Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media	A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2018-09-27
• Last updated: 2018-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study