Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Trial Comparing EmbryoScope With EmbryoScope+.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522350
Recruitment Status : Terminated (Device has been FDA approved.)
First Posted : May 11, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Vitrolife
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Infertility Device: EmbryoScope Device: EmbryoScope+ Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing EmbryoScope Time-Lapse System With the New Model EmbryoScope+.
Actual Study Start Date : September 6, 2017
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: EmbryoScope
Standard of care embryo incubator.
Device: EmbryoScope
Standard of care arm

Experimental: EmbryoScope+
New experimental embryo incubator.
Device: EmbryoScope+
Experimental arm




Primary Outcome Measures :
  1. Number of Day 3 Embryos [ Time Frame: Day 3 post retrieval ]
    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+

  2. Number of Day 5 Embryos [ Time Frame: Day 5 post retrieval ]
    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 :
  1. Implantation Rate [ Time Frame: 5-6 weeks post retrieval ]
    Presence of a gestational sac

  2. Pregnancy Rate [ Time Frame: 2 weeks post retrieval ]
    Positive Bhcg



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522350


Locations
Layout table for location information
United States, New York
Center for Reproductive Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Vitrolife
Investigators
Layout table for investigator information
Principal Investigator: Nikica Zaninovic, PhD Center for Reproductive Medicine
  Study Documents (Full-Text)

Documents provided by Weill Medical College of Cornell University:
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03522350    
Other Study ID Numbers: 1612017837
First Posted: May 11, 2018    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Weill Medical College of Cornell University:
Infertility
Embryo develpoment
IVF
ICSI
EmbryoScope
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility