Comparison of Global, G-TL, & Cornell Media

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03687697
• Other study ID #: 1707018347
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 1, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: September 2018
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo development	Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.	Day 5
Secondary	Implantation rate	The ratio of embryo implantation measured through ultrasound	4 weeks
Secondary	Pregnancy rate	The ratio of pregnancy measured through ßHCG	6 weeks