Trial Outcomes & Findings for Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator (NCT NCT02852356)

Results Overview

Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level \>50mIU/mL is considered to be a successful pregnancy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

14 days after embryo transfer

Results posted on

2024-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Control Incubator Standard Incubator	MIRI-TL Timelapse Incubator Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Incubator n=31 Participants Standard Incubator	MIRI-TL Timelapse Incubator n=31 Participants Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator	Culture Coin Dish Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator	Control Dish Control Dish for embryo culture	Total n=62 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=31 Participants	0 Participants n=31 Participants	—	—	0 Participants n=62 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=31 Participants	31 Participants n=31 Participants	—	—	62 Participants n=62 Participants
Age, Categorical >=65 years	0 Participants n=31 Participants	0 Participants n=31 Participants	—	—	0 Participants n=62 Participants
Sex: Female, Male Female	31 Participants n=31 Participants	31 Participants n=31 Participants	—	—	62 Participants n=62 Participants
Sex: Female, Male Male	0 Participants n=31 Participants	0 Participants n=31 Participants	—	—	0 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 14 days after embryo transfer

Population: number in incubator equals number in dish

Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level \>50mIU/mL is considered to be a successful pregnancy.

Outcome measures

Outcome measures
Measure	Control Incubator n=31 Participants Standard Incubator	MIRI-TL Timelapse Incubator n=31 Participants Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator	Culture Coin Dish Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator	Control Dish Control Dish for embryo culture
Number of Participants With a Positive bHCG Level as Detected by a Blood Test	19 Participants	19 Participants	—	—

SECONDARY outcome

Timeframe: 28 days

Population: number in incubator equals number in dish

Presence of Gestational Sac by ultrasound indicates a positive pregnancy.

Outcome measures

Outcome measures
Measure	Control Incubator n=31 Participants Standard Incubator	MIRI-TL Timelapse Incubator n=31 Participants Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator	Culture Coin Dish Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator	Control Dish Control Dish for embryo culture
Number of Patients With Embryo Implantation	15 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: 7 days

Population: number in incubator equals number in dish

Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)

Outcome measures

Outcome measures
Measure	Control Incubator n=150 Embryos Standard Incubator	MIRI-TL Timelapse Incubator n=165 Embryos Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator	Culture Coin Dish Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator	Control Dish Control Dish for embryo culture
Embryo Development	52 Embryos	54 Embryos	—	—

POST_HOC outcome

Timeframe: 9 months

Population: No participants in the culture coin Dish or the control dish.

Reported live birth of a child

Outcome measures

Outcome measures
Measure	Control Incubator n=31 Participants Standard Incubator	MIRI-TL Timelapse Incubator n=31 Participants Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator	Culture Coin Dish Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator	Control Dish Control Dish for embryo culture
Number of Patients With Live Birth	10 participants	9 participants	—	—

Adverse Events

Control Incubator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MIRI-TL Timelapse Incubator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Culture Coin Dish

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Dish

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

Director

Ovation Fertility

Phone: 5126107474

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place