Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

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.

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.

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