Clinical trial NCT06581068: Automation of the In Vitro Fertilization Laboratory
Official title: Automation of the In Vitro Fertilization Laboratory: A Validation Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
ART
Lead sponsor: Conceivable Life Sciences
Sponsor class: INDUSTRY
Collaborators: name: New Hope Fertility Center
name: Reina Madre
First posted: 2024-08-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Autonomy
timeFrame: 9 months
measure: Procedural timings
timeFrame: 9 months
Secondary outcomes:
measure: Sperm motility post preparation
timeFrame: 9 months
measure: Denudation survival rate
timeFrame: 9 months
measure: ICSI damage rate
timeFrame: 9 months
measure: Normal fertilization rate
timeFrame: 9 months
measure: Blastocyst development rate
timeFrame: 9 months
measure: Usable blastocyst development rate
timeFrame: 9 months
measure: Blastocyst cryosurvival rate
timeFrame: 9 months
measure: Implantation rate
timeFrame: 9 months
measure: Clinical pregnancy rate
timeFrame: 9 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: New Hope Fertility Centre, Mexico City
city: Mexico City
country: Mexico
facility: Reina Madre
Study officials:
affiliation: Conceivable Life Sciences
name: Jacques Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: