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.

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility
• Intervention / Treatment: Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Center for Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Global vs. G-TL Media; 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; A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.
EXPERIMENTAL: Global vs. Cornell's C3 Media; 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; A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.
EXPERIMENTAL: Global vs. Cornell's sequential Media; 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; A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (ACTUAL): September 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: IVF
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1707018347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes