Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator (TiMMI)

Ovation Fertility

Status: Completed

Conditions: Fertility

Treatments: Device: MIRI-TL Incubator

Study type: Interventional

Funder types: Other

Identifiers

NCT02852356

2016-TiMMI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups

Control Incubator

No Intervention group

Description:

Standard Incubator

MIRI-TL Timelapse Incubator

Experimental group

Description:

Timelapse incubator

Treatment:

Device: MIRI-TL Incubator

Culture Coin Dish

Experimental group

Description:

Culture Coin dish for embryo culture

Treatment:

Device: MIRI-TL Incubator

Control dish

No Intervention group

Description:

Control Dish for embryo culture