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Completed

NCT Number: NCT02852356

Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

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.

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Key information

Conditions

Fertility

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ovation Fertility

Austin, Texas, 78731, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIRI-TL Incubator

Device

MIRI-TL Timelapse incubator

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Patients With Embryo Implantation

    Time frame: 28 days

    Presence of Gestational Sac by ultrasound indicates a positive pregnancy.

  2. Embryo Development

    Time frame: 7 days

    Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)

Sponsors and collaborators

Lead sponsor

Ovation Fertility

Other

Registry information

Official study title

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

Acronym: TiMMI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2016
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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