InfertilityNCT06581068
Automation of the In Vitro Fertilization Laboratory
A study testing AURA assisted ART treatment in people with Infertility and ART, run by Conceivable Life Sciences at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility, ART
- What is being tested?
- AURA assisted ART treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesMexico
- Study dates
- 3 Dec 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
New Hope Fertility Centre, Mexico City
Mexico City, Mexico City, 11000
Reina Madre
Mexico City
About this study
Official title: Automation of the In Vitro Fertilization Laboratory: A Validation Study
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
- Being tested
- AURA assisted ART treatment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURA assisted ART treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AURA assisted ART treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomy
proportion of tasks successfully completed by the AURA system without requiring human intervention.
Measured: 9 months
Procedural timings
time employed by the AURA system to complete each of its automated tasks.
Measured: 9 months
Secondary outcomes (9)
Sperm motility post preparation
proportion of sperm cells displaying motility (progressive) following sperm preparation.
Measured: 9 months
Denudation survival rate
proportion of oocytes that do not lyse or degenerate at the end of automated egg discovery and denudation.
Measured: 9 months
ICSI damage rate
Proportion of oocytes that lyse or degenerate within 24 hours after ICSI.
Measured: 9 months
Normal fertilization rate
proportion of oocytes with two pronuclei (and two polar bodies if assessable) 16 hrs after ICSI.
Measured: 9 months
Blastocyst development rate
proportion of embryos with expanded/expanding blastocoele and discernible inner cell mass (ICM) and trophectoderm (TE) observed on day 5 of development (where ICSI is performed on Day 0) as a function of normally fertilized oocytes.
Measured: 9 months
Usable blastocyst development rate
proportion of blastocysts of sufficient quality for transfer or cryopreservation observed within 6 days of fertilization as a function of mature (MII) eggs injected with sperm during ICSI.
Measured: 9 months
Blastocyst cryosurvival rate
proportion of cryopreserved blastocysts that present re-expansion within 2 hours of warming.
Measured: 9 months
Implantation rate
number of gestational sacs detected by ultrasound scan performed at gestation weeks 5-8 per total number of embryos transferred.
Measured: 9 months
Clinical pregnancy rate
number of patients with fetal heartbeats detected by ultrasound scan performed at gestation weeks 5-8 per total number of patients with an embryo transfer.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start3 Dec 2024
- Primary completion21 Oct 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conceivable Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hope Fertility Center, Reina Madre, Nascere
- Responsible party
- Sponsor
- Investigators
- Jacques Cohen, PhD, Principal investigator, Conceivable Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581068
- Sponsor's protocol ID
- PRC-IN-017
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automation of the In Vitro Fertilization Laboratory: A Validation Study
- ClinicalTrials.gov ID
- NCT06581068
- Acronym / sponsor ID
- PRC-IN-017
- Conditions
- Infertility, ART
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Conceivable Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Hope Fertility Center, Reina Madre, Nascere
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 21 Oct 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AURA assisted ART treatment | Experimental | Device: AURA assisted ART treatmentThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- For women utilizing donor eggs (egg donor age 18-28 years):
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURA assisted ART treatmentThe 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. | Device | AURA assisted ART treatment |
Primary outcome
Autonomy
Time frame: 9 months
proportion of tasks successfully completed by the AURA system without requiring human intervention.
Procedural timings
Time frame: 9 months
time employed by the AURA system to complete each of its automated tasks.
9 secondary outcomes
Sperm motility post preparation
Time frame: 9 months
Denudation survival rate
Time frame: 9 months
ICSI damage rate
Time frame: 9 months
Normal fertilization rate
Time frame: 9 months
Blastocyst development rate
Time frame: 9 months
Usable blastocyst development rate
Time frame: 9 months
Blastocyst cryosurvival rate
Time frame: 9 months
Implantation rate
Time frame: 9 months
Clinical pregnancy rate
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Cohen, PhD principal investigator
Conceivable Life Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AURA assisted ART treatment in people with Infertility and ART, run by Conceivable Life Sciences at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomy (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.