Automation of the In Vitro Fertilization Laboratory
NCT Number: NCT06581068
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infertility|ART
Interventions: DEVICE: AURA assisted ART treatment
Sponsor: Conceivable Life Sciences
Collaborators: New Hope Fertility Center|Instituto Nacional de Perinatologia|Reina Madre
Sex: ALL
Age: ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11
Completion Date: 2025-10
Locations: New Hope Fertility Centre, Mexico City, Mexico City, 11000, Mexico|Instituto Nacional de Perinatología, Mexico City, Mexico|Reina Madre, Mexico City, Mexico

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 C:SPERM. Cumulus-oocyte complexes (COCs) containing the oocytes will be isolated from follicular fluid using the subsystem C:EGG. One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinic's standard operating procedure. All other COCs will continue automated procedures and will be denuded, fertilized, incubated, and vitrified using the AURA subsystems C:EGG. C:ICSI, C:CULTURE and C:VIT, 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 device's 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 AURA's 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 AURA's hardware and software operation.

Primary Outcome Measures: Autonomy, proportion of tasks successfully completed by the AURA system without requiring human intervention., 9 months|Procedural timings, time employed by the AURA system to complete each of its automated tasks., 9 months
Secondary Outcome Measures: Sperm motility post preparation, proportion of sperm cells displaying motility (progressive) following sperm preparation., 9 months|Denudation survival rate, proportion of oocytes that do not lyse or degenerate at the end of automated egg discovery and denudation., 9 months|ICSI damage rate, Proportion of oocytes that lyse or degenerate within 24 hours after ICSI., 9 months|Normal fertilization rate, proportion of oocytes with two pronuclei (and two polar bodies if assessable) 16 hrs after ICSI., 9 months|Blastocyst development rate, proportion of embryos with expanded/expanding blastocoele and discernible inner cell mass (ICM) and trophectoderm (TE) observed on day 5 of development (where ICSI is performed on Day 0) as a function of normally fertilized oocytes., 9 months|Usable blastocyst development rate, proportion of blastocysts of sufficient quality for transfer or cryopreservation observed within 6 days of fertilization as a function of mature (MII) eggs injected with sperm during ICSI., 9 months|Blastocyst cryosurvival rate, proportion of cryopreserved blastocysts that present re-expansion within 2 hours of warming., 9 months|Implantation rate, number of gestational sacs detected by ultrasound scan performed at gestation weeks 5-8 per total number of embryos transferred., 9 months|Clinical pregnancy rate, number of patients with fetal heartbeats detected by ultrasound scan performed at gestation weeks 5-8 per total number of patients with an embryo transfer., 9 months