NCT03687697

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

July 31, 2018

Last Update Submit

September 26, 2018

Conditions

Infertility

Keywords

IVF

Outcome Measures

Primary Outcomes (1)

  • Embryo development

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

    Day 5

Secondary Outcomes (2)

  • Implantation rate

    4 weeks

  • Pregnancy rate

    6 weeks

Study Arms (3)

Global vs. G-TL Media

EXPERIMENTAL

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

Global vs. Cornell's C3 Media

EXPERIMENTAL

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

Global vs. Cornell's sequential Media

EXPERIMENTAL

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

Interventions

Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 mediaBIOLOGICAL

A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.

Global vs. Cornell's C3 MediaGlobal vs. Cornell's sequential MediaGlobal vs. G-TL Media

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMaternal age- 40 years of age or younger Paternal age- 65 years of age or younger
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or younger (maternal)
  • years of age or younger (paternal)
  • 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

You may not qualify if:

  • Patients with less than 10 oocytes
  • Co-culture patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Reproductive Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Nikica Zaninovic, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2018

First Posted

September 27, 2018

Study Start

April 1, 2018

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)