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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture at Center for Human Reproduction(CHR):an Open Label Randomized Clinical Trial

Conditions
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Infertility

Intervention / Treatment
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* Device: Embryoscope Time Lapse System
* Device: Standard Embryo Culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients already planning to undergo in vitro fertilization Exclusion Criteria: Patients with more than 12 oocytes will be excluded from this trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embryoscope Time Lapse System<br>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<br>* 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.<br>|
| Active Comparator: Standard Embryo Culture<br>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<br>* Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.<br>* Other names: Standard water jacketed incubator system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personnel Effort | Number of minutes spent by laboratory personnel technical staff in support of each system | Three days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo Quality | Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation) | Three Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Embryo Culture, Laboratory Technique