Trial Outcomes & Findings for Embryo Selection by Time Lapse Monitoring for Single Embryo Transfer ("SET") (NCT NCT01694641)

Results Overview

rise in beta HCG 12-14 days after transfer

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

161 participants

Primary outcome timeframe

12-14 days after transfer

Results posted on

2018-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Time Lapse Embryo Observation Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection. time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse	Standard Embryo Monitoring Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
Overall Study STARTED	80	81
Overall Study COMPLETED	68	71
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Embryo Selection by Time Lapse Monitoring for Single Embryo Transfer ("SET")

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Time Lapse Embryo Observation n=80 Participants Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection. time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse	Standard Embryo Monitoring n=81 Participants Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.	Total n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31.2 years STANDARD_DEVIATION 2.7 • n=5 Participants	32.1 years STANDARD_DEVIATION 2.5 • n=7 Participants	31.7 years STANDARD_DEVIATION 2.6 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	81 Participants n=7 Participants	161 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 Hungary	80 participants n=5 Participants	81 participants n=7 Participants	161 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-14 days after transfer

Population: All patients randomized are analyszs (intention to treat analysis).

rise in beta HCG 12-14 days after transfer

Outcome measures

Outcome measures
Measure	Time Lapse Embryo Observation n=80 Participants Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection. time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse	Standard Embryo Monitoring n=81 Participants Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
Pregnancy Rate	34 Participants	26 Participants

SECONDARY outcome

Timeframe: delivery after 24 weeks

Population: All patients randomzed regardless whether completed the study or not according to their assignment (intention to treat population).

live birth after 24 weeks gestation

Outcome measures

Outcome measures
Measure	Time Lapse Embryo Observation n=80 Participants Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection. time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse	Standard Embryo Monitoring n=81 Participants Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
Live Birth	34 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)

a score based on 8 observations by time lapse monitoring

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: perinatal outcome assessed after delivery

gestational age at delivery, birth weight,

Outcome measures

Outcome data not reported

Adverse Events

Time Lapse Embryo Observation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Embryo Monitoring

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 Peter Kovacs

Kaali Inst. IVF Center

Phone: 36-1-202-2802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place