Comparison of Global, G-TL, & Cornell Media

Weill Cornell Medicine (WCM)

Status and phase: Withdrawn; Phase 4

Conditions: Infertility

Treatments: Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media

Study type: Interventional

Funder types: Other

Identifiers

NCT03687697

1707018347

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 40 years of age or younger (maternal)
• 65 years of age or younger (paternal)
• 10 or more oocytes
• Fresh or frozen oocytes (including donor)
• Fresh or frozen (including donor) sperm can be used
• ICSI only
• Frozen embryos from this study can be included in the outcome portion of this study.
• PGD and/or PGS patients included

Exclusion criteria

• Patients with less than 10 oocytes
• Co-culture patients

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Global vs. G-TL Media

Experimental group

Description:

Global medium will be compared with G-TL (Time-Lapse) medium.

Treatment:

Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media

Global vs. Cornell's C3 Media

Experimental group

Description:

Global medium will be compared with Cornell's C3 single step medium.

Treatment:

Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media

Global vs. Cornell's sequential Media

Experimental group

Description:

Global medium will be compared with Cornell's C1/C2 sequential medium.

Treatment:

Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media