N/A
N=62
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator
Fertility
Bottom Line
View on ClinicalTrials.gov: NCT02852356 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With a Positive bHCG Level as Detected by a Blood Test — 19; 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MIRI-TL Incubator (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ovation Fertility
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Positive bHCG Level as Detected by a Blood Test |
19; 19 | — |
| SECONDARY Number of Patients With Embryo Implantation |
15; 14 | — |
| SECONDARY Embryo Development |
52; 54 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02852356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.