Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521372
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
NiOS Non-Invasive Oocyte Sorting Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NiOS
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 pregnancy in patients undergoing IVF
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 that was developed to assess the probability of an oocyte to fertilize and develop into a blastocyst ball of rapidly dividing cells that will become an embryo It is a non-invasive image analysis tool that uses artificial intelligence AI to predict outcomes based on a single 2-D image of a mature oocyte denuded oocyte prior to freezing or sperm injection ICSI Magenta was designed and built specifically to analyze oocytes in the IVF lab It was created based on more than 20000 images of oocytes and their known reproductive outcomes It is an image analysis neural network that can identify important signals beyond the limited morphological features detected by embryologists like facial recognition systems in use today Without the development of this AI tool there are no standard assessments for oocyte quality within the IVF process The use of Magenta in this study is investigational
In standard IVF laboratories oocytes can undergo their developmental period alone single culture or be grouped with other oocytes during this time group culture Research has shown that group culture has some developmental advantages over single culture
What is this study for At the moment there is no standard method to sort oocytes into groups for their developmental period Currently oocytes are sorted in a random manner We hope that Magenta analysis will provide information at this early stage of development and inform a better way to sort oocytes into groups from lowest to highest quality The objective of this research study is to compare sorting the oocytes randomly to utilizing the MagentaTM tool for oocyte assessment to determine which oocytes should be grouped together Study participants will be randomly assigned to the control random sorting or the study Magenta analysis groups at the time of oocyte retrieval You have an equal chance of being assigned to either group We intend to enroll 450 subjects
In standard IVF laboratories oocytes can undergo their developmental period alone single culture or be grouped with other oocytes during this time group culture Research has shown that group culture has some developmental advantages over single culture
What is this study for At the moment there is no standard method to sort oocytes into groups for their developmental period Currently oocytes are sorted in a random manner We hope that Magenta analysis will provide information at this early stage of development and inform a better way to sort oocytes into groups from lowest to highest quality The objective of this research study is to compare sorting the oocytes randomly to utilizing the MagentaTM tool for oocyte assessment to determine which oocytes should be grouped together Study participants will be randomly assigned to the control random sorting or the study Magenta analysis groups at the time of oocyte retrieval You have an equal chance of being assigned to either group We intend to enroll 450 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None