Comparison of Global, G-TL, & Cornell Media

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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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

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Global vs. G-TL Media

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Global vs. Cornell's C3 Media

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Global vs. Cornell's sequential Media

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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