Trial Outcomes & Findings for Use of Time-lapse Morphological Kinetics in the Selection of Blastocysts (NCT NCT02081859)

NCT ID: NCT02081859

Last Updated: 2017-06-08

Results Overview

Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-06-08

Participant Flow

Participant milestones

Measure	Conventional Grading Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Overall Study STARTED	150	150
Overall Study COMPLETED	116	119
Overall Study NOT COMPLETED	34	31

Reasons for withdrawal

Measure	Conventional Grading Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Overall Study No fertilization	2	2
Overall Study No sperm	1	0
Overall Study Unanticipated freeze all cycle	2	6
Overall Study < 4 embryos	27	23
Overall Study Other reasons	2	0

Baseline Characteristics

Use of Time-lapse Morphological Kinetics in the Selection of Blastocysts

Baseline characteristics by cohort

Measure	Conventional Grading n=116 Participants Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data n=119 Participants Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.	Total n=235 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 3.9 • n=5 Participants	33.6 years STANDARD_DEVIATION 4 • n=7 Participants	33.3 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	119 Participants n=7 Participants	235 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants	119 participants n=7 Participants	235 participants n=5 Participants
Nulliparous	97 Participants n=5 Participants	94 Participants n=7 Participants	191 Participants n=5 Participants
Length of infertility	31.5 months STANDARD_DEVIATION 22.4 • n=5 Participants	31.4 months STANDARD_DEVIATION 22.4 • n=7 Participants	31.5 months STANDARD_DEVIATION 22.3 • n=5 Participants
AMH	3.5 ng/mL STANDARD_DEVIATION 3.2 • n=5 Participants	3.7 ng/mL STANDARD_DEVIATION 4.2 • n=7 Participants	3.6 ng/mL STANDARD_DEVIATION 3.7 • n=5 Participants
Mean embryo transferred	1.9 embryo STANDARD_DEVIATION 0.6 • n=5 Participants	2.0 embryo STANDARD_DEVIATION 0.5 • n=7 Participants	1.95 embryo STANDARD_DEVIATION 0.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.

Outcome measures

Measure	Conventional Grading n=116 Participants Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data n=119 Participants Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Clinical Pregnancy Rate	73 Participants	81 Participants

SECONDARY outcome

Timeframe: 6 weeks

Percent of embryos implanted assessed at time of ultrasound

Outcome measures

Measure	Conventional Grading n=116 Participants Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data n=119 Participants Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Implantation Rate	45.2 Percentage of embryos	51.0 Percentage of embryos

Adverse Events

Conventional Grading

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Embryoscope Data

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Conventional Grading n=116 participants at risk Embryos will be scored based on conventional criteria. Conventional Criteria	Embryoscope Data n=119 participants at risk Embryos will be scored based on both conventional rating and embryoscope data. Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring.
Investigations	— 0/0 • 6 weeks All cause mortality and adverse events were not collected.	— 0/0 • 6 weeks All cause mortality and adverse events were not collected.

Additional Information

Lynn Borzi (Research Administrator)

Cleveland Clinic

Phone: 216-445-3158

Email: BORZIL@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place