Actively Recruiting
Automation of the In Vitro Fertilization Laboratory: A Validation Study
Led by Conceivable Life Sciences · Updated on 2026-03-18
150
Participants Needed
2
Research Sites
35 weeks
Total Duration
On this page
Sponsors
C
Conceivable Life Sciences
Lead Sponsor
H
Hope Fertility Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the automation of laboratory procedures in assisted reproductive technology (ART) treatments, specifically focusing on in vitro fertilization (IVF) using intracytoplasmic sperm injection (ICSI). This study aims to assess an automated system called AURA, which processes sperm, eggs, and embryos through five subsystems. The goal is to describe AURA's performance, including its automation level, efficiency, and throughput, and to compare its clinical performance against standard benchmarks in a non-inferiority analysis. The AURA system will automate key laboratory steps during ART treatment, starting after ovarian stimulation on the day of egg collection. Sperm samples will be prepared using the C:SPERM subsystem. Follicular fluid and cumulus-oocyte complexes (COCs) will be processed by the C:EGG subsystem. One in four eggs will be randomly removed from the system for standard care, while the others will continue through automated denudation, fertilization by C:ICSI, embryo incubation by C:CULTURE, and vitrification by C:VIT. All procedures will be supervised by a laboratory manager who can intervene if needed. Participants will undergo the ART treatment with laboratory processes managed by the AURA system over a 9-month period. Researchers will monitor various outcomes including autonomy of the system, procedural timings, sperm motility after preparation, rates of fertilization and embryo development, cryosurvival of blastocysts, implantation rates, and clinical pregnancy rates. Data on the device's hardware and software operation will also be collected. The study provides detailed monitoring of the automated system's performance and clinical outcomes related to IVF procedures.
CONDITIONS
Brief Title
Automation of the In Vitro Fertilization Laboratory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before treatment
- Medical indication to perform assisted reproductive technology
- Body mass index between 20 and 29 kg/m2 for female participants
- For women using their own eggs: Anti-Müllerian Hormone (AMH) value of at least 1.5 ng/mL and age between 18 and 39 years
- For women using donor eggs: age between 18 and 45 years with donor age 18 to 28 years
You will not qualify if you...
- Diagnosis of recurrent pregnancy loss
- Ovaries inaccessible for puncture
- History of total or partial fertilization failure in previous fertility treatment
- History of repeated implantation failure (three unsuccessful embryo transfers)
- Uterine factors that may affect success or risk, such as fibroids or uterine surgeries
- Untreated hydrosalpinx
- Severe endometriosis (stage III or IV), presence or history of endometriomas
- Polycystic ovarian syndrome
- Severe male factor infertility including low sperm concentration or motility, globozoospermia, seminal infections, or surgically retrieved sperm
- Pre-existing conditions compromising reproductive health or uncontrolled hormonal disorders
- Any other abnormalities affecting success as determined by clinical personnel
- Inability to follow medical protocols or schedules
- Intercurrent medical disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the egg collection day and subsequent laboratory processing period
Participants undergo automated laboratory processing of their assisted reproductive technology (ART) treatment using the AURA device, including sperm preparation, egg retrieval, fertilization, embryo culture, and cryopreservation.
1 visit on egg collection day (in-person)
Duration - Up to 9 months after treatment
Participants are monitored for outcomes including fertilization success, embryo development, implantation, and clinical pregnancy rates following the automated ART treatment.
Follow-up visits as scheduled up to 9 months
Trial Site Locations
Total: 2 locations
1
New Hope Fertility Centre, Mexico City
Mexico City, Mexico City, Mexico, 11000
Actively Recruiting
2
Reina Madre
Mexico City, Mexico
Actively Recruiting
Research Team
S
Stephanie Kuku, MD
G
Giuseppe Silvestri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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