Automation of the In Vitro Fertilization Laboratory

NCT ID: NCT06581068

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2025-10-31

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AURA assisted ART treatment

The laboratory element of the patient's ART treatment will be automated through the use of the AURA device. This includes sperm preparation and egg retrieval from follicular fluid. 1 out of every 4 eggs will be randomly removed from the AURA system and treated by standard care. The remaining eggs will be maintained in the AURA system and further processed automatically for egg denudation, fertilization, embryo culture, embryo cryopreservation.

Group Type: EXPERIMENTAL

AURA assisted ART treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed consent signed by the patients before treatment.
• Medical indication to perform assisted reproductive technology.
• Body mass index between 20 and 29 kg/m2 (female participants only).
• For women with indication of utilizing autologous eggs:

• Anti-Müllerian Hormone (AMH) value of at least 1.5 ng/mL.
• 18 - 39 years of age.
• For women utilizing donor eggs (egg donor age 18-28 years):

• 18 - 45 years of age.

Exclusion Criteria

• Patients diagnosed with recurrent pregnancy loss.
• Inaccessible ovaries for puncture.
• History of total or partial fertilization failure in a previous fertility treatment.
• History of repeated implantation failure defined as three previous unsuccessful embryo transfers.
• Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at the discretion of the medical team and based on its impact on success and/or risk to the patient or the pregnancy may compromise treatment prognosis).
• Untreated hydrosalpinx
• Severe endometriosis III, IV, presence of endometriomas and/or history of endometrioma resection.
• Polycystic ovarian syndrome.
• Patients with any of the following severe male factor infertility:

• Sperm concentrations less than 5 million per mL
• Progressive motility less than 5%
• Others (e.g, globozoospermia and seminal infections) at the discretion of the medical team and based on its impact on success.
• Surgically retrieved sperm (TESE, MESA, PESA)
• Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronic degenerative and autoimmune diseases, uncontrolled hormonal disorders).
• Any other case of abnormalities that could compromise success rates according to the criteria of clinical personnel in charge.
• Inability to adhere to the medical protocols and/or schedules for personal reasons.
• Intercurrent medical disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New Hope Fertility Center

OTHER

Sponsor Role: collaborator

Reina Madre

UNKNOWN

Sponsor Role: collaborator

Conceivable Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Cohen, PhD

Role: PRINCIPAL_INVESTIGATOR

Conceivable Life Sciences

Locations

New Hope Fertility Centre, Mexico City

Mexico City, , Mexico

Site Status: RECRUITING

Reina Madre

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Stephanie Kuku, MD

Role: CONTACT

Phone: 1-833-737-2448

Email: Stephanie@conceivable.life

Giuseppe Silvestri

Role: CONTACT

Email: Giuseppe@conceivable.life

Facility Contacts

Zaira Chávez, MD

Role: primary

Miguel A Estrada

Role: primary

Other Identifiers

PRC-IN-017

Identifier Type: -

Identifier Source: org_study_id