Randomized Trial Comparing EmbryoScope With EmbryoScope+.
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EmbryoScope
EmbryoScope+
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Embryo develpoment, IVF, ICSI, EmbryoScope
Eligibility Criteria
Inclusion Criteria:
- 40 years of age or younger (maternal)
- 65 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
Exclusion Criteria:
- 3 or more previous failed cycles
- Sperm obtained by testicular biopsy
- Co-culture patients
Sites / Locations
- Center for Reproductive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EmbryoScope
EmbryoScope+
Arm Description
Standard of care embryo incubator.
New experimental embryo incubator.
Outcomes
Primary Outcome Measures
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+
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+
Secondary Outcome Measures
Implantation Rate
Presence of a gestational sac
Pregnancy Rate
Positive Bhcg
Full Information
NCT ID
NCT03522350
First Posted
February 20, 2018
Last Updated
May 6, 2019
Sponsor
Weill Medical College of Cornell University
Collaborators
Vitrolife
1. Study Identification
Unique Protocol Identification Number
NCT03522350
Brief Title
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
Official Title
Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Device has been FDA approved.
Study Start Date
September 6, 2017 (Actual)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
June 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Vitrolife
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a randomized, controlled, single-center study in otherwise healthy infertile female subjects undergoing in vitro fertilization (IVF). The subjects recruited for this study will be among those patients who have been diagnosed with infertility and are planning to undergo IVF at the center where this study is being performed. The subjects will have undergone the usual informed consent procedure at the center.
Subjects will undergo ovarian stimulation, oocyte retrieval, IVF, and Intra Cytoplasmic Sperm Injection (ICSI) procedure following the center's usual procedures. At the time of retrieval, participant's oocytes will be randomly assigned to both groups for comparison: Standard EmbryoScope Time-Lapse system versus EmbryoScope+. The best quality embryos are selected for embryo transfer and the pregnancy outcome is evaluated.
"Best grade" embryos will be transferred regardless of EmbryoScope use. The standard EmbryoScope as well as the EmbryoScope+ monitor system as assigned during the randomization process will be used to observe the embryo development and document timing of embryo cleavages and morphology dynamics. Subjects will not be provided with the time- lapse images.
Endpoints will be Day 3 and Day 5/6 embryo development, implantation and pregnancy rate. The study is approximately 2 months, the estimated time it takes a physician to perform one IVF-ART treatment cycle. If embryos are frozen, the patient may be in the study until the time they choose to thaw the embryos or up to 1 year if they become pregnant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Embryo develpoment, IVF, ICSI, EmbryoScope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EmbryoScope
Arm Type
Active Comparator
Arm Description
Standard of care embryo incubator.
Arm Title
EmbryoScope+
Arm Type
Experimental
Arm Description
New experimental embryo incubator.
Intervention Type
Device
Intervention Name(s)
EmbryoScope
Intervention Description
Standard of care arm
Intervention Type
Device
Intervention Name(s)
EmbryoScope+
Intervention Description
Experimental arm
Primary Outcome Measure Information:
Title
Number of Day 3 Embryos
Description
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+
Time Frame
Day 3 post retrieval
Title
Number of Day 5 Embryos
Description
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+
Time Frame
Day 5 post retrieval
Secondary Outcome Measure Information:
Title
Implantation Rate
Description
Presence of a gestational sac
Time Frame
5-6 weeks post retrieval
Title
Pregnancy Rate
Description
Positive Bhcg
Time Frame
2 weeks post retrieval
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)
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
Exclusion Criteria:
3 or more previous failed cycles
Sperm obtained by testicular biopsy
Co-culture patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikica Zaninovic, PhD
Organizational Affiliation
Center for Reproductive Medicine
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
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
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