Automation of the In Vitro Fertilization Laboratory

Официальное название

Automation of the In Vitro Fertilization Laboratory: A Validation Study

Обзор

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.

Вмешательства

• Устройство 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)

Первичные конечные точки

• Autonomy [Срок оценки: 9 months]
• Procedural timings [Срок оценки: 9 months]

Вторичные конечные точки (9)

• Sperm motility post preparation [Срок оценки: 9 months]
• Denudation survival rate [Срок оценки: 9 months]
• ICSI damage rate [Срок оценки: 9 months]
• Normal fertilization rate [Срок оценки: 9 months]
• Blastocyst development rate [Срок оценки: 9 months]
• Usable blastocyst development rate [Срок оценки: 9 months]
• Blastocyst cryosurvival rate [Срок оценки: 9 months]
• Implantation rate [Срок оценки: 9 months]
• Clinical pregnancy rate [Срок оценки: 9 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 2 центра

• New Hope Fertility Centre, Mexico City — Mexico City
• Reina Madre — Mexico City

Идентификаторы

NCT: NCT06581068 · PRC-IN-017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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