Comparison of Global, G-TL, & Cornell Media

Study Overview
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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.

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.

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

Conditions
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Infertility

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


Participation Criteria
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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 Exclusion Criteria: Patients with less than 10 oocytes Co-culture patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Global vs. G-TL Media<br>Global medium will be compared with G-TL (Time-Lapse) medium. | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media<br>* A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.<br>|
| Experimental: Global vs. Cornell's C3 Media<br>Global medium will be compared with Cornell's C3 single step medium. | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media<br>* A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.<br>|
| Experimental: Global vs. Cornell's sequential Media<br>Global medium will be compared with Cornell's C1/C2 sequential medium. | Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media<br>* A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo development | Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups. | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | The ratio of embryo implantation measured through ultrasound | 4 weeks | 
| Pregnancy rate | The ratio of pregnancy measured through βHCG | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF