Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02852356
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : December 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ovation Fertility

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 2, 2016
Last Update Posted Date December 27, 2017
Study Start Date  ICMJE July 2016
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
Pregnancy Success [ Time Frame: 14 days ]
Live Birth
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
Pregnancy Success [ Time Frame: 2 years ]
Live Birth
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2016)
  • Implantation [ Time Frame: 28 days ]
    Presence of Gestational Sac
  • Embryo Development [ Time Frame: 7 days ]
    Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2016)
  • Implantation [ Time Frame: 2 years ]
    Presence of Gestational Sac
  • Embryo Development [ Time Frame: 2 years ]
    Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Official Title  ICMJE Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Fertility
Intervention  ICMJE Device: MIRI-TL Incubator
MIRI-TL Timelapse incubator
Study Arms  ICMJE
  • No Intervention: Control Incubator
    Standard Incubator
  • Experimental: MIRI-TL Timelapse Incubator
    Timelapse incubator
    Intervention: Device: MIRI-TL Incubator
  • Experimental: Culture Coin Dish
    Culture Coin dish for embryo culture
    Intervention: Device: MIRI-TL Incubator
  • No Intervention: Control dish
    Control Dish for embryo culture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2017)
62
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2016)
500
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02852356
Other Study ID Numbers  ICMJE 2016-TiMMI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.
Responsible Party Ovation Fertility
Study Sponsor  ICMJE Ovation Fertility
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthew VerMilyea, PhD Ovation Fertility
PRS Account Ovation Fertility
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP