Trial Outcomes & Findings for Randomized Trial Comparing EmbryoScope With EmbryoScope+. (NCT NCT03522350)

Last Updated: 2019-05-31

Results Overview

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+

Recruitment status

TERMINATED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

Day 3 post retrieval

Results posted on

2019-05-31

Participant Flow

Patients undergoing IVF were be recruited to participate in the study. Those agreeing to participate consented to have their embryos incubated in the new Embryoscope+ as opposed to the current one being used as standard of care.

18 subjects will undergo IVF. Participant's oocytes at retrieval will be randomly assigned to both groups for comparison: Standard EmbryoScope 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.

Unit of analysis: Oocytes

Participant milestones

Participant milestones
Measure	Embryoscope + Embryoscope +	Embryoscope Embryoscope
Overall Study STARTED	18 115	18 116
Overall Study COMPLETED	18 115	18 116
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial Comparing EmbryoScope With EmbryoScope+.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=18 Participants This includes all participants - oocytes were randomized to standard of care embryo incubator and experimental Embryoscope +
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.6 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 post retrieval

Population: Number of day 3 embryos compared in both groups

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+

Outcome measures

Outcome measures
Measure	Embryoscope + n=115 embryos Embryoscope +	Embryoscope n=116 embryos Embryoscope
Number of Day 3 Embryos	42 embryos	42 embryos

PRIMARY outcome

Timeframe: 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+

Outcome measures

Outcome measures
Measure	Embryoscope + n=115 embryos Embryoscope +	Embryoscope n=116 embryos Embryoscope
Number of Day 5 Embryos	43 embryos	51 embryos

SECONDARY outcome

Timeframe: 5-6 weeks post retrieval

Presence of a gestational sac

Outcome measures

Outcome measures
Measure	Embryoscope + n=18 Participants Embryoscope +	Embryoscope n=18 Participants Embryoscope
Implantation Rate	3 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 weeks post retrieval

Positive Bhcg

Outcome measures

Outcome measures
Measure	Embryoscope + n=18 Participants Embryoscope +	Embryoscope n=18 Participants Embryoscope
Pregnancy Rate	4 Participants	9 Participants

Adverse Events

All Participants Enrolled

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

Nikica Zaninovic, PhD

Weill Cornell Medical College

Phone: 212-746-5790

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place