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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Incubator | No Intervention | Standard Incubator | |
| MIRI-TL Timelapse Incubator | Experimental | Timelapse incubator |
|
| Culture Coin Dish | Experimental | Culture Coin dish for embryo culture |
|
| Control dish | No Intervention | Control Dish for embryo culture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIRI-TL Incubator | Device | MIRI-TL Timelapse incubator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Embryo Implantation | Presence of Gestational Sac by ultrasound indicates a positive pregnancy. | 28 days |
| Embryo Development | Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew VerMilyea, PhD | Ovation Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovation Fertility | Austin | Texas | 78731 | United States |
Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.
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Project has ceased
Project has ceased
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Incubator | Standard Incubator |
| FG001 | MIRI-TL Timelapse Incubator | Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator |
| FG002 | Culture Coin Dish | Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator |
| FG003 | Control Dish | Control Dish for embryo culture |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients in the dishes equal number in incubator
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Incubator | Standard Incubator |
| BG001 | MIRI-TL Timelapse Incubator | Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | number in incubator equals number in dish | Posted | Number | Participants | 14 days after embryo transfer |
|
9 months
No adverse events were reported in this study. All-Cause Mortality was not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Incubator | Standard Incubator | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Ovation Fertility | 5126107474 | tex@ovationfertility.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2016 | Nov 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2016 | Nov 17, 2022 | ICF_001.pdf |
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| 7 days |
| BG002 | Culture Coin Dish | Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator |
| BG003 | Control Dish | Control Dish for embryo culture |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Culture Coin Dish |
Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator |
| OG003 | Control Dish | Control Dish for embryo culture |
|
|
| Secondary | Number of Patients With Embryo Implantation | Presence of Gestational Sac by ultrasound indicates a positive pregnancy. | number in incubator equals number in dish | Posted | Number | Participants | 28 days |
|
|
|
| Secondary | Embryo Development | Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts) | number in incubator equals number in dish | Posted | Count of Units | Embryos | 7 days | Embryos | Embryos |
|
|
|
| Post-Hoc | Number of Patients With Live Birth | Reported live birth of a child | No participants in the culture coin Dish or the control dish. | Posted | Number | participants | 9 months |
|
|
|
| 0 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | MIRI-TL Timelapse Incubator | Timelapse incubator MIRI-TL Incubator: MIRI-TL Timelapse incubator | 0 | 0 | 0 | 31 | 0 | 31 |
| EG002 | Culture Coin Dish | Culture Coin dish for embryo culture MIRI-TL Incubator: MIRI-TL Timelapse incubator | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Control Dish | Control Dish for embryo culture | 0 | 0 | 0 | 0 | 0 | 0 |
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| >=65 years |
|