Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581068
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Automation of the In Vitro Fertilization Laboratory
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Automation of the In Vitro Fertilization Laboratory A Validation Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Enrolled patients will undergo an Assisted Reproductive technology ART treatment using intracytoplasmic sperm injection ICSI the direct injection of a single sperm cell into an oocyte as the method of insemination In this prospective cohort study patients sperm eggs and embryos will be processed using an automated system called AURA Conceivable Life Sciences which consists of five subsystems Specifically sperm samples will be prepared for fertilization using the subsystem CSPERM Cumulus-oocyte complexes COCs containing the oocytes will be isolated from follicular fluid using the subsystem CEGG One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinics standard operating procedure All other COCs will continue automated procedures and will be denuded fertilized incubated and vitrified using the AURA subsystems CEGG CICSI CCULTURE and CVIT respectively All automated procedures will be conducted under the supervision of a laboratory manager who can intervene address any potential anomalies and override any steps undertaken by the automated AURA system The study aims to deliver a descriptive evaluation of the AURA system including assessing the devices performance defined by its level of automation efficiency and throughput As a secondary objective the study aims to characterize the clinical performance of each of AURAs subsystems and correlate this performance against pre-established benchmarks in a non-inferiority statistical analysis Finally the study seeks to collect technical data related to AURAs hardware and software operation
Detailed Description:
None
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