Fertility
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.
Detailed description
Following randomization and standard ovarian stimulation protocols to obtain a sufficient number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm Injection (ICSI). If a patient has been randomized to the study group, all inseminated oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen embryo transfer cycle.
Interventions
DEVICEMIRI-TL Incubator
MIRI-TL Timelapse incubator
Sponsors
Ovation Fertility
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years of age * Women undergoing in vitro fertilization treatment using their own or frozen oocytes * Fresh or Frozen Embryo Transfer * Fertilization by ICSI * At least 4 diploid (2PN) embryos at fertilization check * Willing to have all inseminated oocytes imaged by Miri * Willing to comply with study protocol and procedures Willing to provide written informed consent
Exclusion criteria
* Fertilization using surgically removed sperm * History of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Positive bHCG Level as Detected by a Blood Test | 14 days after embryo transfer | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Embryo Implantation | 28 days | Presence of Gestational Sac by ultrasound indicates a positive pregnancy. |
| Embryo Development | 7 days | Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Incubator Standard Incubator | 31 |
| MIRI-TL Timelapse Incubator Timelapse incubator
MIRI-TL Incubator: MIRI-TL Timelapse incubator | 31 |
| Culture Coin Dish Culture Coin dish for embryo culture
MIRI-TL Incubator: MIRI-TL Timelapse incubator | 0 |
| Control Dish Control Dish for embryo culture | 0 |
| Total | 62 |
Baseline characteristics
| Characteristic | Control Incubator | MIRI-TL Timelapse Incubator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 31 Participants | 62 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 31 Participants | 31 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With a Positive bHCG Level as Detected by a Blood Test
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.
Time frame: 14 days after embryo transfer
Population: number in incubator equals number in dish
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Incubator | Number of Participants With a Positive bHCG Level as Detected by a Blood Test | 19 Participants |
| MIRI-TL Timelapse Incubator | Number of Participants With a Positive bHCG Level as Detected by a Blood Test | 19 Participants |
Secondary
Embryo Development
Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
Time frame: 7 days
Population: number in incubator equals number in dish
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Control Incubator | Embryo Development | 52 Embryos |
| MIRI-TL Timelapse Incubator | Embryo Development | 54 Embryos |
Secondary
Number of Patients With Embryo Implantation
Presence of Gestational Sac by ultrasound indicates a positive pregnancy.
Time frame: 28 days
Population: number in incubator equals number in dish
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Incubator | Number of Patients With Embryo Implantation | 15 Participants |
| MIRI-TL Timelapse Incubator | Number of Patients With Embryo Implantation | 14 Participants |
Post Hoc
Number of Patients With Live Birth
Reported live birth of a child
Time frame: 9 months
Population: No participants in the culture coin Dish or the control dish.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Incubator | Number of Patients With Live Birth | 10 participants |
| MIRI-TL Timelapse Incubator | Number of Patients With Live Birth | 9 participants |