Study Stopped
Device has been FDA approved.
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of the study is to compare the current EmbryoScope Time-Lapse System being used in IVF which has become standard of care to the new model EmbryoScope to demonstrate that the EmbryoScope+ is as safe and reliable as the EmbryoScope.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2017
CompletedFirst Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2018
CompletedResults Posted
Study results publicly available
May 31, 2019
CompletedMay 31, 2019
May 1, 2019
9 months
February 20, 2018
May 6, 2019
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Day 3 Embryos
Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
Day 3 post retrieval
Number of Day 5 Embryos
Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+
Day 5 post retrieval
Secondary Outcomes (2)
Implantation Rate
5-6 weeks post retrieval
Pregnancy Rate
2 weeks post retrieval
Study Arms (2)
EmbryoScope
ACTIVE COMPARATORStandard of care embryo incubator.
EmbryoScope+
EXPERIMENTALNew experimental embryo incubator.
Interventions
Eligibility Criteria
You may qualify if:
- years of age or younger (maternal)
- years of age or younger (paternal)
- Fresh or frozen (including donor) sperm can be used
- Fresh oocytes only (including donor)
- Frozen embryos from this study can be included in the outcome portion of this study.
- Single or double Blastocyst transfer only
You may not qualify if:
- or more previous failed cycles
- Sperm obtained by testicular biopsy
- Co-culture patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- Vitrolifecollaborator
Study Sites (1)
Center for Reproductive Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nikica Zaninovic, PhD
- Organization
- Weill Cornell Medical College
Study Officials
- PRINCIPAL INVESTIGATOR
Nikica Zaninovic, PhD
Center for Reproductive Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
May 11, 2018
Study Start
September 6, 2017
Primary Completion
June 4, 2018
Study Completion
June 4, 2018
Last Updated
May 31, 2019
Results First Posted
May 31, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share