Automation of the In Vitro Fertilization Laboratory

NCT06581068 | Recruiting

• 1 other identifier: PRC-IN-017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Sperm motility post preparation

  9 months

• Denudation survival rate

  9 months

• ICSI damage rate

  9 months

• Normal fertilization rate

  9 months

• Blastocyst development rate

  9 months

Study Arms (1)

AURA assisted ART treatment

EXPERIMENTAL

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.

Device: AURA assisted ART treatment

Interventions

AURA assisted ART treatment 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.

AURA assisted ART treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• years of age.
• For women utilizing donor eggs (egg donor age 18-28 years):
• years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Conceivable Life Sciences: lead
• Hope Fertility Center: collaborator
• Reina Madre: collaborator
• Nascere: collaborator

Study Sites (2)

New Hope Fertility Centre, Mexico City

Mexico City, Mexico City, 11000, Mexico

RECRUITING

Reina Madre

Mexico City, Mexico

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jacques Cohen, PhD

  Conceivable Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Kuku, MD

CONTACT

1-833-737-2448; Stephanie@conceivable.life

Giuseppe Silvestri

CONTACT

Giuseppe@conceivable.life

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. Proposals should be directed to Jacques@Conceivable.life; to gain access, data requestors will need to sign a data access agreement.

Locations

ME (2)