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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

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.

Condition or disease Intervention/treatment Phase
Fertility Device: MIRI-TL Incubator Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
Study Start Date : July 2016
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Arm Intervention/treatment
No Intervention: Control Incubator
Standard Incubator
Experimental: MIRI-TL Timelapse Incubator
Timelapse incubator
Device: MIRI-TL Incubator
MIRI-TL Timelapse incubator

Experimental: Culture Coin Dish
Culture Coin dish for embryo culture
Device: MIRI-TL Incubator
MIRI-TL Timelapse incubator

No Intervention: Control dish
Control Dish for embryo culture



Primary Outcome Measures :
  1. Pregnancy Success [ Time Frame: 14 days ]
    Live Birth


Secondary Outcome Measures :
  1. Implantation [ Time Frame: 28 days ]
    Presence of Gestational Sac

  2. Embryo Development [ Time Frame: 7 days ]
    Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852356


Locations
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United States, Texas
Ovation Fertility
Austin, Texas, United States, 78731
Sponsors and Collaborators
Ovation Fertility
Investigators
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Principal Investigator: Matthew VerMilyea, PhD Ovation Fertility
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Responsible Party: Ovation Fertility
ClinicalTrials.gov Identifier: NCT02852356    
Other Study ID Numbers: 2016-TiMMI-001
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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.