Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

Not Applicable

Completed

• Conditions: Fertility
• Interventions: Device: MIRI-TL Incubator

• Registration Number: NCT02852356
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Results First Submitted: 2022-09-29
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Results First Posted: 2024-05-24
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culture Coin Dish	MIRI-TL Incubator	Culture Coin dish for embryo culture
MIRI-TL Timelapse Incubator	MIRI-TL Incubator	Timelapse incubator

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Positive bHCG Level as Detected by a Blood Test	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 Outcome Measures

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

Trial Locations

Locations (1)

Ovation Fertility; 🇺🇸 Austin, Texas, United States