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

• Sponsor: Center for Human Reproduction (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02246309
• Collaborator: FertiliTech Inc. (Industry)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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 Names: Standard water jacketed incubator system

Outcome Measures

Primary Outcome Measures

1. Personnel Effort [Three days]

   Number of minutes spent by laboratory personnel technical staff in support of each system

Secondary Outcome Measures

1. Embryo Quality [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 [4 weeks]

   Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients already planning to undergo in vitro fertilization

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Human Reproduction	New York	New York	United States	10021

Sponsors and Collaborators

• Center for Human Reproduction
• FertiliTech Inc.

Investigators

• Principal Investigator: David Barad, MD, Center for Human Reproduction

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Center for Human Reproduction
• ClinicalTrials.gov Identifier: NCT02246309
• Other Study ID Numbers: ER08282014-01
• First Posted: Sep 22, 2014
• Last Update Posted: May 17, 2018
• Last Verified: Dec 1, 2015

• Keywords provided by Center for Human Reproduction: Infertility; Embryo Culture; Laboratory Technique
• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Recruitment Details	This study was completed during 3.5 months between December 2014 and March 2015, the time period our center (Center for Human Reproduction in New York City).
Pre-assignment Detail	134 patients were offered participation during the study period. Ten were excluded because they were using embryo banking. Eighty five declined participation leaving only 49 qualified and/or consented to participate.

Arm/Group Title	Embryoscope Time Lapse System	Standard Embryo Culture
Arm/Group Description	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Period Title: Overall Study
STARTED	16	15
COMPLETED	16	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Embryoscope Time Lapse System	Standard Embryo Culture	Total
Arm/Group Description	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.	Total of all reporting groups
Overall Participants	16	15	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.8 (4)	40.4 (6.97)	39.5 (4.8)
Sex: Female, Male (Count of Participants)
Female	16 100%	15 100%	31 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope Time Lapse System	Standard Embryo Culture
Arm/Group Description	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Measure Participants	16	15
Measure embryos	44	42
Mean (Standard Error) [technical staff minutes spent per embryo]	301.2 (80.8)	137.6 (52.7)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope Time Lapse System	Standard Embryo Culture
Arm/Group Description	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Measure Participants	16	15
Mean (Standard Error) [Embryos]	1.2 (0.3)	1.2 (0.2)

3. Other Pre-specified Outcome

Title	Clinical Pregnancy Rate
Description	Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Embryoscope Time Lapse System	Standard Embryo Culture
Arm/Group Description	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Measure Participants	16	15
Count of Participants [Participants]	3 18.8%	3 20%

Adverse Events

Time Frame	One Month
Arm/Group Title	Embryoscope Time Lapse System		Standard Embryo Culture
Arm/Group Description	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. 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.		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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
All Cause Mortality
	Embryoscope Time Lapse System		Standard Embryo Culture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Serious Adverse Events
	Embryoscope Time Lapse System		Standard Embryo Culture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Embryoscope Time Lapse System		Standard Embryo Culture
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.