Automation of the In Vitro Fertilization Laboratory

Last updated: December 18, 2024
Sponsor: Conceivable Life Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

AURA assisted ART treatment

Clinical Study ID

NCT06581068
PRC-IN-017
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 unsuccessfulembryo transfers.

  • Uterine factors (e.g. fibroids, uterine surgeries, Müllerian malformations) at thediscretion of the medical team and based on its impact on success and/or risk to thepatient or the pregnancy may compromise treatment prognosis).

  • Untreated hydrosalpinx

  • Severe endometriosis III, IV, presence of endometriomas and/or history ofendometrioma 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 themedical team and based on its impact on success.

  • Surgically retrieved sperm (TESE, MESA, PESA)

  • Pre-existing conditions compromising reproductive (e.g., thrombophilia, chronicdegenerative and autoimmune diseases, uncontrolled hormonal disorders).

  • Any other case of abnormalities that could compromise success rates according to thecriteria of clinical personnel in charge.

  • Inability to adhere to the medical protocols and/or schedules for personal reasons.

  • Intercurrent medical disorder

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: AURA assisted ART treatment
Phase:
Study Start date:
December 03, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Instituto Nacional de Perinatología

    Mexico City,
    Mexico

    Site Not Available

  • New Hope Fertility Centre, Mexico City

    Mexico City, 11000
    Mexico

    Active - Recruiting

  • Reina Madre

    Mexico City,
    Mexico

    Active - Recruiting

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