Trial Outcomes & Findings for Comparison Of The Embryoscope Time-Lapse System With Standard Embryo Culture (NCT NCT02246309)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Three days

Results posted on

2018-05-17

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	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. 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.	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. Standard Embryo Culture: Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
Overall Study STARTED	16	15
Overall Study COMPLETED	16	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Embryoscope Time Lapse System n=16 Participants 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.	Standard Embryo Culture n=15 Participants 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 n=31 Participants Total of all reporting groups
Age, Continuous	38.8 years STANDARD_DEVIATION 4 • n=5 Participants	40.4 years STANDARD_DEVIATION 6.97 • n=7 Participants	39.5 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three days

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

Outcome measures

Outcome measures
Measure	Standard Embryo Culture n=42 embryos 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.	Embryoscope Time Lapse System n=44 embryos 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.
Personnel Effort	137.6 technical staff minutes spent per embryo Standard Error 52.7	301.2 technical staff minutes spent per embryo Standard Error 80.8

SECONDARY outcome

Timeframe: Three Days

Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)

Outcome measures

Outcome measures
Measure	Standard Embryo Culture n=15 Participants 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.	Embryoscope Time Lapse System n=16 Participants 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.
Embryo Quality	1.2 Embryos Standard Error 0.2	1.2 Embryos Standard Error 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

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

Outcome measures

Outcome measures
Measure	Standard Embryo Culture n=15 Participants 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.	Embryoscope Time Lapse System n=16 Participants 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.
Clinical Pregnancy Rate	3 Participants	3 Participants

Adverse Events

Embryoscope Time Lapse System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Embryo Culture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Barad, Director of Clinical Research

Center for Human Reproduction

Phone: 2129944400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place