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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The AURA device consists of five subsystems, which will operate in logical sequence to deliver comprehensive automation of the laboratory element of an ART cycle. The AURA treatment begins after ovarian stimulation, on the day of egg collection. A sperm sample is provided on the same day of egg collection. Sperm samples will be prepared by the C:SPERM subsystem. Follicular fluid obtained at egg collection will be processed by the C:EGG subsystem. 3 out of every 4 cumulus-oocyte complexes (COCs) recovered will be denuded by the C:EGG subsystem. These denuded eggs will be fertilized by the C:ICSI subsystem, incubated in the C:CULTURE subsystem and all resulting suitable embryos will be vitrified by the C:VIT subsystem. Thawed embryos may be used in conventional frozen embryo transfers.
New Hope Fertility Centre, Mexico City
Mexico City, Mexico City, Mexico
RECRUITINGReina Madre
Mexico City, Mexico
RECRUITINGAutonomy
proportion of tasks successfully completed by the AURA system without requiring human intervention.
Time frame: 9 months
Procedural timings
time employed by the AURA system to complete each of its automated tasks.
Time frame: 9 months
Sperm motility post preparation
proportion of sperm cells displaying motility (progressive) following sperm preparation.
Time frame: 9 months
Denudation survival rate
proportion of oocytes that do not lyse or degenerate at the end of automated egg discovery and denudation.
Time frame: 9 months
ICSI damage rate
Proportion of oocytes that lyse or degenerate within 24 hours after ICSI.
Time frame: 9 months
Normal fertilization rate
proportion of oocytes with two pronuclei (and two polar bodies if assessable) 16 hrs after ICSI.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
Blastocyst cryosurvival rate
proportion of cryopreserved blastocysts that present re-expansion within 2 hours of warming.
Time frame: 9 months
Implantation rate
number of gestational sacs detected by ultrasound scan performed at gestation weeks 5-8 per total number of embryos transferred.
Time frame: 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.
Time frame: 9 months
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