Comparison of Global, G-TL, & Cornell Media

• ClinicalTrials.gov Identifier: NCT03687697
• Recruitment Status: Withdrawn
• First Posted: September 27, 2018
• Last Update Posted: September 27, 2018
• Sponsor: Weill Medical College of Cornell University
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infertility	Biological: Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Embryo development [ Time Frame: Day 5 ]
   Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.

Secondary Outcome Measures :

1. Implantation rate [ Time Frame: 4 weeks ]
   The ratio of embryo implantation measured through ultrasound
2. Pregnancy rate [ Time Frame: 6 weeks ]
   The ratio of pregnancy measured through βHCG

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Maternal age- 40 years of age or younger Paternal age- 65 years of age or younger
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

Center for Reproductive Medicine

New York, New York, United States, 10065

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

• Principal Investigator: Nikica Zaninovic, PhD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03687697
• Other Study ID Numbers: 1707018347
• First Posted: September 27, 2018
• Last Update Posted: September 27, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Weill Medical College of Cornell University:

IVF

Additional relevant MeSH terms:

Infertility