Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)

Conditions
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Fertility

Intervention / Treatment
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* Device: MIRI-TL Incubator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Incubator<br>Standard Incubator | |
| Experimental: MIRI-TL Timelapse Incubator<br>Timelapse incubator | Device: MIRI-TL Incubator<br>* MIRI-TL Timelapse incubator<br>|
| Experimental: Culture Coin Dish<br>Culture Coin dish for embryo culture | Device: MIRI-TL Incubator<br>* MIRI-TL Timelapse incubator<br>|
| No Intervention: Control dish<br>Control Dish for embryo culture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Success | Live Birth | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation | Presence of Gestational Sac | 28 days | 
| Embryo Development | Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts) | 7 days |