NCT02852356

Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Ovation Fertility · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Fertility

Interventions

Type	Name	Description
DEVICE	MIRI-TL Incubator	MIRI-TL Timelapse incubator

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2016-08-02
• Last updated: 2024-05-24
• Results posted: 2024-05-24

Locations

1 site across 1 country: United States