Automation of the In Vitro Fertilization Laboratory

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.

Conditions

• Infertility
• ART

Interventions

DEVICE

AURA assisted ART treatment

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.

Sponsors & Collaborators

• Hope Fertility Center

  collaborator UNKNOWN

• Reina Madre

  collaborator UNKNOWN

• Nascere

  collaborator UNKNOWN

• Conceivable Life Sciences

  lead INDUSTRY

Principal Investigators

• Jacques Cohen, PhD · Conceivable Life Sciences

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-03

Primary Completion

2026-06-30

Completion

2027-02-28

Countries

• Mexico

Study Locations