Status:
RECRUITING
The Aim of This Study is to Determine if Oocyte Sorting for Group Culture Using an Artificial Intelligence Image Analysis Tool (MagentaTM) Increases the Usable Blastocyst Yield and Subsequent Pregnancy in Patients Undergoing IVF
Lead Sponsor:
Ovation Fertility
Collaborating Sponsors:
Future Fertility
Conditions:
Infertility Primary
Eligibility:
All Genders
Brief Summary
The aim of this study is to determine if oocyte sorting for group culture using an artificial intelligence image analysis tool (MagentaTM) increases the usable blastocyst yield and subsequent pregnanc...
Detailed Description
Introduction Magenta™ is a software image analysis tool developed by Future Fertility that allows personalized reproductive prediction for each oocyte (egg cell) analyzed. It is a cloud-based software...
Eligibility Criteria
Inclusion
- Fresh MII oocytes
- ICSI cycles with patient's or donor's sperm
- Patient's or donor's oocytes
- Full IVF cycle information available (including total number of oocytes retrieved, total MII oocytes, fertilization, embryo and blastocyst development, as well as ploidy status or implantation results, and 6-7 week ultrasound, if applicable)
- Good quality images of MII oocytes taken with a specified camera (Basler) and Future Fertility Software
- Single embryo transfers (SETs) at blastocyst stage.
- Blastocyst freeze-all cycles
Exclusion
- Severe male factor infertility (\<1 million motile), including surgically retrieved sperm.
- ICSI cycles inseminating in vitro matured (IVM) oocytes
- Rescue ICSI oocytes (oocytes failed standard IVF and are re-inseminated by ICSI)
- Low quality images - Poor quality images on day of upload or before unblinding
- Lack of correlating reproductive outcomes (full IVF lab results not available).
- Autologous or donor frozen/warmed oocytes
- Day 3 embryo transfers or cleavage stage embryo freezing
- Patients with less than 6 mature oocytes
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 2 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06521372
Start Date
January 1 2024
End Date
January 2 2027
Last Update
July 26 2024
Active Locations (3)
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1
Ovation Fertility Las Vegas
Las Vegas, Nevada, United States, 89113
2
Ovation Fertility Cincinnati
Cincinnati, Ohio, United States, 45209
3
Ovation Fertility - Nashville
Nashville, Tennessee, United States, 37203