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Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture

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ClinicalTrials.gov Identifier: NCT02246309
Recruitment Status : Terminated (Equipment was loaned Lifglobal, Guilford, CT, USA and had to be returned.)
First Posted : September 22, 2014
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
FertiliTech Inc.
Information provided by (Responsible Party):
Center for Human Reproduction

Brief Summary:

"Embryoscopes," allow for embryo culture to be performed in an automated incubation system under time lapse photography. Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF (in vtro fertilization) pregnancy rates. They also claim that use of this system saves laboratory personnel time.

This study will randomize approximately 120 patients (60 in each arm) to standard embryo culture or to culture in an Embryoscope. The primary endpoint will be a comparison of time spent by the laboratory personnel with each system. Secondary endpoints will be IVF outcomes.


Condition or disease Intervention/treatment Phase
Infertility Device: Embryoscope Time Lapse System Device: Standard Embryo Culture Not Applicable

Detailed Description:

A large number of IVF centers all around the world are converting from standard embryology practice, where embryos are by embryologists manually processed during culture, to so-called "embryoscopes," where embryo culture is performed in an automated incubation system under time lapse photography.

Manufacturers of these systems (and investigators who have used these systems) claim that the availability of 24-hour time-lapse photographic control improves embryo selection and, therefore, IVF pregnancy rates. They also claim that use of this system saves laboratory personnel time. The FDA has so far, therefore, approved for sale at least 2 such systems In the USA.

(i) Our analysis of the published literature has failed to find studies in support of the claim that utilization of such equipment really improves pregnancy rates with IVF; and (ii) Investigators are concerned that CHR's highly adversely selected patient population may demonstrate different utilization outcomes from standard patient populations, especially since this equipment is usually utilized to culture embryos to blastocyst stage (days 5/6), while CHR cultures most patients only to day-3.

Investigators, therefore, contacted the manufacturer of the first FDA approved system, and explained our concerns. The manufacturer agreed to loan us one of their systems for a 4-months long study free of charge (CHR just pays a nominal amount for installation and training costs) but will be financially responsible for supplies.

During these 4 months, CHR will perform an open-label prospective (registered) and randomized clinical trial, in which investigators, based on computerized randomization, will assign all CHR patients (who agree to participate with informed written consent), either to standard embryology or "embryoscope" embryology.

Recruiting approximately 30 patients per month into the study is anticipated, which would give us a population of ~n=60 in each study group.

Patient with excessive numbers of eggs retrieved (>12) will be excluded since the purpose of this study is to investigate the utility of the system in a relatively adversely selected patient population. All other patients will be offered participation.

The study will have as primary end point a time analysis of laboratory manpower, under which the time spent on each patient by embryologist will be recorded and compared and as secondary end point IVF cycle outcome, defined by number of good quality embryos available for transfer, implantation rates and clinical pregnancy rates.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Embryoscope Time Lapse System
All embryos from patients randomized to this arm will be cultured in the Embryoscope culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.
Device: Embryoscope Time Lapse System
The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.

Active Comparator: Standard Embryo Culture
All embryos from patients randomized to this arm will be cultured in the standard embryo culture system from the time of insemination until the time of transfer on day 3. All staff interaction with the embryos or with maintenance or supervision of the system will be timed.
Device: Standard Embryo Culture
Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Other Name: Standard water jacketed incubator system




Primary Outcome Measures :
  1. Personnel Effort [ Time Frame: Three days ]
    Number of minutes spent by laboratory personnel technical staff in support of each system


Secondary Outcome Measures :
  1. Embryo Quality [ Time Frame: Three Days ]
    Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)


Other Outcome Measures:
  1. Clinical Pregnancy Rate [ Time Frame: 4 weeks ]
    Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients already planning to undergo in vitro fertilization

Exclusion Criteria:

  • Patients with more than 12 oocytes will be excluded from this trial

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): NCT02246309


Locations
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United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
Sponsors and Collaborators
Center for Human Reproduction
FertiliTech Inc.
Investigators
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Principal Investigator: David Barad, MD Center for Human Reproduction

Publications of Results:
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Responsible Party: Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT02246309    
Other Study ID Numbers: ER08282014-01
First Posted: September 22, 2014    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: December 2015
Keywords provided by Center for Human Reproduction:
Infertility
Embryo Culture
Laboratory Technique
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female