Comparison of Global, G-TL, & Cornell Media

Phase 4

Withdrawn

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

• Registration Number: NCT03687697
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Study First Submitted: 2018-07-31
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-26
• Last Update Submitted: 2018-09-26
• Study First Posted: 2018-09-27
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Global vs. Cornell's C3 Media	Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media	Global medium will be compared with Cornell's C3 single step medium.
Global vs. G-TL Media	Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media	Global medium will be compared with G-TL (Time-Lapse) medium.
Global vs. Cornell's sequential Media	Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media	Global medium will be compared with Cornell's C1/C2 sequential medium.

Primary Outcome Measures

Name	Time	Method
Embryo development	Day 5	Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	6 weeks	The ratio of pregnancy measured through βHCG
Implantation rate	4 weeks	The ratio of embryo implantation measured through ultrasound

Trial Locations

Locations (1)

Center for Reproductive Medicine; 🇺🇸 New York, New York, United States