FertilityTiMMINCT02852356
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
A study testing MIRI-TL Incubator in people with Fertility, run by Ovation Fertility at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- MIRI-TL Incubator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Fertilization using surgically removed sperm
- History of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fertility
- Being tested
- MIRI-TL Incubator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRI-TL IncubatorDevice
MIRI-TL Timelapse incubator
| Study group | Role | What they receive |
|---|---|---|
| Control Incubator | No intervention | Standard Incubator |
| MIRI-TL Timelapse Incubator | Experimental | Timelapse incubator Receives: Device: MIRI-TL Incubator |
| Culture Coin Dish | Experimental | Culture Coin dish for embryo culture Receives: Device: MIRI-TL Incubator |
| Control dish | No intervention | Control Dish for embryo culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days after embryo transfer
Secondary outcomes (2)
Number of Patients With Embryo Implantation
Presence of Gestational Sac by ultrasound indicates a positive pregnancy.
Measured: 28 days
Embryo Development
Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovation Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew VerMilyea, PhD, Principal investigator, Ovation Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852356
- Sponsor's protocol ID
- 2016-TiMMI-001
- Acronym
- TiMMI
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2016
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational and Validation Study Using Time-lapse Morphometry MIRI Imaging Incubator (TiMMI Study)
- ClinicalTrials.gov ID
- NCT02852356
- Acronym / sponsor ID
- TiMMI / 2016-TiMMI-001
- Conditions
- Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ovation FertilityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Incubator | No intervention | –Standard Incubator |
| MIRI-TL Timelapse Incubator | Experimental | Device: MIRI-TL IncubatorTimelapse incubator |
| Culture Coin Dish | Experimental | Device: MIRI-TL IncubatorCulture Coin dish for embryo culture |
| Control dish | No intervention | –Control Dish for embryo culture |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Fertilization using surgically removed sperm
- History of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRI-TL IncubatorMIRI-TL Timelapse incubator | Device | Culture Coin Dish, MIRI-TL Timelapse Incubator |
Primary outcome
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.
2 secondary outcomes
Number of Patients With Embryo Implantation
Time frame: 28 days
Embryo Development
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Non-identified data regarding embryo development and pregnancy outcomes may be shared and discussed through presentations and publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew VerMilyea, PhD principal investigator
Ovation Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRI-TL Incubator in people with Fertility, run by Ovation Fertility at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Positive bHCG Level as Detected by a Blood Test (time frame: 14 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.