Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150846
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-11-21
Brief Title:
Sperm Video Recording Protocol
Sponsor:
BAIBYS Fertility
Organization:
BAIBYS Fertility
Study Overview
Official Title:
Sperm Video Recording Protocol
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to obtain anonymous video clips of male semen at high magnification to manually select out of the video spermatozoon images and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS Fertility System The study will enroll males attending the clinic who may elect to contribute their unused excess sample materials from semen analysis or IVFICSI Intracytoplasmic sperm injection which is a technique used during in vitro fertilization IVF
Detailed Description:
The study will obtain video clips of 40 male subjects semen sample at high magnification Each subject contributes 1 sample from which 10 minutes of video is recorded
A total of 720000 frames are expected to be collected at 30 frames per second At least 6000 frames will be selected at random from these 10800-14500 frames to be labeled by at least two embryologists The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition The data collected will be utilized to train the Artificial Intelligence AI used within the BAIBYS System
A total of 720000 frames are expected to be collected at 30 frames per second At least 6000 frames will be selected at random from these 10800-14500 frames to be labeled by at least two embryologists The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition The data collected will be utilized to train the Artificial Intelligence AI used within the BAIBYS System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None