Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

Fertility Clinical Trial

— TiMMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852356
• Other study ID #: 2016-TiMMI-001
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 22, 2017

Study information

• Verified date: April 2024
• Source: Ovation Fertility
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility

Intervention

Device:
• MIRI-TL Incubator
MIRI-TL Timelapse incubator

Locations

Country	Name	City	State
United States	Ovation Fertility	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ovation Fertility

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Positive bHCG Level as Detected by a Blood Test	Human Chorionic Gonadotropin (hormone made by cells formed in the placenta) are detected by a blood test. An hCG level >50mIU/mL is considered to be a successful pregnancy.	14 days after embryo transfer
Secondary	Number of Patients With Embryo Implantation	Presence of Gestational Sac by ultrasound indicates a positive pregnancy.	28 days
Secondary	Embryo Development	Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)	7 days