Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 12/29/2017 |
| Start Date: | July 2016 |
| End Date: | December 22, 2017 |
Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
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.
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.
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.
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
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