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

April 29, 2024 updated by: Ovation Fertility

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78731
        • Ovation Fertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a Positive bHCG Level as Detected by a Blood Test
Time Frame: 14 days after embryo transfer
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo Development
Time Frame: 7 days
Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
7 days
Number of Patients With Embryo Implantation
Time Frame: 28 days
Presence of Gestational Sac by ultrasound indicates a positive pregnancy.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovation Fertility

Investigators

  • Principal Investigator: Matthew VerMilyea, PhD, Ovation Fertility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 22, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

August 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-TiMMI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.

IPD Sharing Time Frame

Project has ceased

IPD Sharing Access Criteria

Project has ceased

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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