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Comparison of Global, G-TL, & Cornell Media

Primary Purpose

Infertility

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring IVF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Reproductive Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Global vs. G-TL Media

Global vs. Cornell's C3 Media

Global vs. Cornell's sequential Media

Arm Description

Global medium will be compared with G-TL (Time-Lapse) medium.

Global medium will be compared with Cornell's C3 single step medium.

Global medium will be compared with Cornell's C1/C2 sequential medium.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Implantation rate
The ratio of embryo implantation measured through ultrasound
Pregnancy rate
The ratio of pregnancy measured through βHCG

Full Information

First Posted
July 31, 2018
Last Updated
September 26, 2018
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT03687697
Brief Title
Comparison of Global, G-TL, & Cornell Media
Official Title
A Randomized Controlled Trial Comparing Global Medium With G-TL, Cornell Single and Sequential Steps Media by the Time-Lapse System.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was halted prior to enrollment of first participant due to non funding and recourses.
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Global vs. G-TL Media
Arm Type
Experimental
Arm Description
Global medium will be compared with G-TL (Time-Lapse) medium.
Arm Title
Global vs. Cornell's C3 Media
Arm Type
Experimental
Arm Description
Global medium will be compared with Cornell's C3 single step medium.
Arm Title
Global vs. Cornell's sequential Media
Arm Type
Experimental
Arm Description
Global medium will be compared with Cornell's C1/C2 sequential medium.
Intervention Type
Biological
Intervention Name(s)
Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media
Intervention Description
A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.
Primary Outcome Measure Information:
Title
Embryo development
Description
Comparison of embryo development using standard assessments of morphology, cell number, and embryo grading, between the different media groups.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Implantation rate
Description
The ratio of embryo implantation measured through ultrasound
Time Frame
4 weeks
Title
Pregnancy rate
Description
The ratio of pregnancy measured through βHCG
Time Frame
6 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Maternal age- 40 years of age or younger Paternal age- 65 years of age or younger
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikica Zaninovic, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproductive Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Global, G-TL, & Cornell Media

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