Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
TiMMI
Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
1 other identifier
interventional
62
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2017
CompletedResults Posted
Study results publicly available
May 24, 2024
CompletedMay 24, 2024
April 1, 2024
1.5 years
July 28, 2016
September 29, 2022
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Patients With Embryo Implantation
28 days
Embryo Development
7 days
Study Arms (4)
Control Incubator
NO INTERVENTIONStandard Incubator
MIRI-TL Timelapse Incubator
EXPERIMENTALTimelapse incubator
Culture Coin Dish
EXPERIMENTALCulture Coin dish for embryo culture
Control dish
NO INTERVENTIONControl Dish for embryo culture
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fertilization using surgically removed sperm
- History of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ovation Fertility
Austin, Texas, 78731, United States
Results Point of Contact
- Title
- Director
- Organization
- Ovation Fertility
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew VerMilyea, PhD
Ovation Fertility
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 2, 2016
Study Start
July 1, 2016
Primary Completion
December 22, 2017
Study Completion
December 22, 2017
Last Updated
May 24, 2024
Results First Posted
May 24, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Project has ceased
- Access Criteria
- Project has ceased
Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.