InfertilityNCT06074835
Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification
A study testing Gamete preparation, ICSI, embryo culture and vitrification robot assistant and Routine Manual ICSI Workflow in people with Infertility, run by Conceivable Life Sciences at 1 site in Mexico.
Trial summary
Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who will rely on manual laboratory processes to achieve fertilization. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Gamete preparation, ICSI, embryo culture and vitrification robot assistant and Routine Manual ICSI Workflow
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMexico
- Study dates
- 30 Oct 2023to 4 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical indication to perform ICSI.
- Informed consent signed by the patients before treatment.
- Medical indication for the use of autologous or donor oocytes.
- Medical indication for the use of autologous or donor sperm.
- Motile sperm.
Who cannot join
- Recurrent pregnancy loss.
- Previous history of total fertilization failure.
- Surgical sperm retrieval.
- Severe male factor infertility.
- Known semen liquefaction problems.
- Any other case abnormalities that could potentially reduce success rates according to the criteria of the senior embryologist in charge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification: A Proof of Concept Study
Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who will rely on manual laboratory processes to achieve fertilization. The most commonly employed method to achieve fertilization is intracytoplasmic sperm injection (ICSI), a treatment that involves the injection of a single sperm cell directly inside an egg. The embryos so obtained are then be maintained in an appropriate environment (incubator) for several days before deciding whether they can be immediately used to attempt to establish a pregnancy (embryo transfer), or should be frozen in preparation for a future treatment (cryopreservation).
The laboratory steps required to complete a full assisted conception treatment (from sperm and egg retrieval, to fertilization, and then to embryo transfer and/or cryopreservation) are often manual and time-consuming, and thus the success of the treatment is highly dependent on the skill of individual staff and outcomes can be affected by fatigue, stress, and workload.
Read more
The combination of robotics and artificial intelligence (AI) has the potential to provide improvements to, and standardize, the fertility laboratory, but such integration has not been achieved routinely. Other medical fields, such as regenerative medicine, have long benefited from the implementation of robotic solutions; however, modern automation has yet to find its way into the fertility laboratory.
The goal for Conceivable Life Sciences (the study sponsor) is the delivery of a suite of solutions that, collectively, will allow a fully autonomous ICSI cycle to take place (from sperm/egg preparation, to sperm injection, to embryo culture and cryopreservation) in an effort to reduce costs, assist laboratory staff, and possibly, improve outcomes. The purpose of this study is to deliver a core aspect of this project: the digital control and individual automation of all key steps of a complete laboratory workflow. The data generated in this study will help the future development of these automated systems.
Patients undergoing an ICSI treatment may be recruited in this study. Their gametes (sperm and/or eggs) may be distributed across two groups (test and control) and undergo one or more elements of an automated full assisted conception workflow (for the test group) or a standard assisted conception workflow (for the control group). Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer.
The main hypothesis of this study is that the use of robotic assistants as part of a full assisted conception cycle may improve laboratory workflows without reducing the treatment success rates.
- Conditions
- Infertility
- Being tested
- Gamete preparation, ICSI, embryo culture and vitrification robot assistant, Routine Manual ICSI Workflow
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamete preparation, ICSI, embryo culture and vitrification robot assistantDevice
Patients undergoing an assisted conception treatment with medical indication to perform ICSI may be recruited in this study. The study will follow a sibling-oocyte and/or sibling embryo study design where oocytes and/or embryos obtained from a specific patient or couple will be randomly distributed across two groups (test and control) and undergo one or more elements of an automated assisted conception laboratory workflow (for the test group) or a standard assisted conception laboratory workflow (for the control group). Before distributing the samples, an embryologist will slightly blur the vision of the samples so that their morphology can no longer be clearly assessed. Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer.
Routine Manual ICSI WorkflowOther
Routine Manual Icsi Workflow
| Study group | Role | What they receive |
|---|---|---|
| Test group (Robot-assisted gamete preparation, ICSI, embryo culture and vitrification) | Experimental | Not described Receives: Device: Gamete preparation, ICSI, embryo culture and vitrification robot assistant |
| Control group (routine manual ICSI workflow) | Active comparator | Not described Receives: Other: Routine Manual ICSI Workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing
Time to complete each automated procedure
Measured: 6 weeks from enrolment
Efficiency
proportion of automated procedures achieving their goal
Measured: 6 weeks from enrolment
Autonomy
proportion of completed procedure not requiring human intervention
Measured: 6 weeks from enrolment
Walk-away time
time savings realized by an embryologist who is able to attend other duties while the robotic assistant is at work
Measured: 6 weeks from enrolment
Secondary outcomes (5)
Sperm survival and quality (seminogram)
Measured: 6 weeks from enrolment
Proportion of oocytes fertilized
Measured: 6 weeks from enrolment
Embryos survival and quality (by morphology assessment)
Measured: 6 weeks from enrolment
Clinical pregnancy rates following embryo transfer
Measured: 8 weeks from enrolment
Live birth rates following embryo transfer
Measured: within 12 months of primary completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Oct 2023
- Primary completion3 Oct 2024
- Study completion4 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conceivable Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074835
- Sponsor's protocol ID
- CP001
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2023
- Last updated
- 20 Nov 2025
- 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). Data sharing is subject to ethical, legal, and privacy considerations. We are committed to following established guidelines and best practices for data sharing. This plan has been updated to provide more detailed information on access criteria.
Publications
Chavez-Badiola A, Valadez Aguilar A, Mendizabal-Ruiz G, Flores-Saiffe Farias A, Hernandez-Morales E, Alvarez Lopez A, Sanchez-Gonzalez DJ, Costa-Borges N, Murray A, Alikani M, Silvestri G, Cohen J. Automation of sperm preparation, oocyte retrieval and denudation, ICSI, and vitrification in IVF: insights from a proof-of-concept study. Hum Reprod. 2026 Oct 26:deag168. doi: 10.1093/humrep/deag168. Online ahead of print.
PubMed 42932986Chavez-Badiola A, Mendizabal-Ruiz G, Flores-Saiffe Farias A, Costa-Borges N, Murray A, Alikani M, Silvestri G, Millan C, Hernandez-Morales E, Valencia-Murillo R, Medina V, Mestres E, Valadez Aguilar A, Ocegueda-Hernandez V, Acosta-Gomez F, Alvarez Lopez A, Acacio M, Matia-Algue Q, Espinoza Figueroa JG, Campos Olmedo LM, Barragan CP, Sanchez-Gonzalez DJ, Cohen J. Automated oocyte retrieval, denudation, sperm preparation, and ICSI in the IVF laboratory: a proof-of-concept study and report of the first live births. Hum Reprod. 2026 Feb 1;41(2):214-230. doi: 10.1093/humrep/deaf240.
PubMed 41453368
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06074835
- Acronym / sponsor ID
- CP001
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Conceivable Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 4 Oct 2025 (actual)
- First posted
- 10 Oct 2023 (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.
Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who will rely on manual laboratory processes to achieve fertilization. The most commonly employed method to achieve fertilization is intracytoplasmic sperm injection (ICSI), a treatment that involves the injection of a single sperm cell directly inside an egg. The embryos so obtained are then be maintained in an appropriate environment (incubator) for several days before deciding whether they can be immediately used to attempt to establish a pregnancy (embryo transfer), or should be frozen in preparation for a future treatment (cryopreservation).
The laboratory steps required to complete a full assisted conception treatment (from sperm and egg retrieval, to fertilization, and then to embryo transfer and/or cryopreservation) are often manual and time-consuming, and thus the success of the treatment is highly dependent on the skill of individual staff and outcomes can be affected by fatigue, stress, and workload.
The combination of robotics and artificial intelligence (AI) has the potential to provide improvements to, and standardize, the fertility laboratory, but such integration has not been achieved routinely. Other medical fields, such as regenerative medicine, have long benefited from the implementation of robotic solutions; however, modern automation has yet to find its way into the fertility laboratory.
The goal for Conceivable Life Sciences (the study sponsor) is the delivery of a suite of solutions that, collectively, will allow a fully autonomous ICSI cycle to take place (from sperm/egg preparation, to sperm injection, to embryo culture and cryopreservation) in an effort to reduce costs, assist laboratory staff, and possibly, improve outcomes. The purpose of this study is to deliver a core aspect of this project: the digital control and individual automation of all key steps of a complete laboratory workflow. The data generated in this study will help the future development of these automated systems.
Patients undergoing an ICSI treatment may be recruited in this study. Their gametes (sperm and/or eggs) may be distributed across two groups (test and control) and undergo one or more elements of an automated full assisted conception workflow (for the test group) or a standard assisted conception workflow (for the control group). Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer.
The main hypothesis of this study is that the use of robotic assistants as part of a full assisted conception cycle may improve laboratory workflows without reducing the treatment success rates.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (Robot-assisted gamete preparation, ICSI, embryo culture and vitrification) | Experimental | Device: Gamete preparation, ICSI, embryo culture and vitrification robot assistant |
| Control group (routine manual ICSI workflow) | Active comparator | Other: Routine Manual ICSI Workflow |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Medical indication to perform ICSI.
- Informed consent signed by the patients before treatment.
- Medical indication for the use of autologous or donor oocytes.
- Medical indication for the use of autologous or donor sperm.
- Motile sperm.
Key exclusion criteria (6 listed)
- Recurrent pregnancy loss.
- Previous history of total fertilization failure.
- Surgical sperm retrieval.
- Severe male factor infertility.
- Known semen liquefaction problems.
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 |
|---|---|---|
| Gamete preparation, ICSI, embryo culture and vitrification robot assistantPatients undergoing an assisted conception treatment with medical indication to perform ICSI may be recruited in this study. The study will follow a sibling-oocyte and/or sibling embryo study design where oocytes and/or embryos obtained from a specific patient or couple will be randomly distributed across two groups (test and control) and undergo one or more elements of an automated assisted conception laboratory workflow (for the test group) or a standard assisted conception laboratory workflow (for the control group). Before distributing the samples, an embryologist will slightly blur the vision of the samples so that their morphology can no longer be clearly assessed. Robotic automation may include any of the following steps: robotic sperm preparation, robotic oocyte selection and denudation, robotic sperm injection, automated embryo culture, and automated cryopreservation. The resulting embryos may be employed for embryo transfer. | Device | Test group (Robot-assisted gamete preparation, ICSI, embryo culture and vitrification) |
| Routine Manual ICSI WorkflowRoutine Manual Icsi Workflow | Other | Control group (routine manual ICSI workflow) |
Primary outcome
Timing
Time frame: 6 weeks from enrolment
Time to complete each automated procedure
Efficiency
Time frame: 6 weeks from enrolment
proportion of automated procedures achieving their goal
Autonomy
Time frame: 6 weeks from enrolment
proportion of completed procedure not requiring human intervention
Walk-away time
Time frame: 6 weeks from enrolment
time savings realized by an embryologist who is able to attend other duties while the robotic assistant is at work
5 secondary outcomes
Sperm survival and quality (seminogram)
Time frame: 6 weeks from enrolment
Proportion of oocytes fertilized
Time frame: 6 weeks from enrolment
Embryos survival and quality (by morphology assessment)
Time frame: 6 weeks from enrolment
Clinical pregnancy rates following embryo transfer
Time frame: 8 weeks from enrolment
Live birth rates following embryo transfer
Time frame: within 12 months of primary completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42932986Chavez-Badiola A, Valadez Aguilar A, Mendizabal-Ruiz G, Flores-Saiffe Farias A, Hernandez-Morales E, Alvarez Lopez A, Sanchez-Gonzalez DJ, Costa-Borges N, Murray A, Alikani M, Silvestri G, Cohen J. Automation of sperm preparation, oocyte retrieval and denudation, ICSI, and vitrification in IVF: insights from a proof-of-concept study. Hum Reprod. 2026 Oct 26:deag168. doi: 10.1093/humrep/deag168. Online ahead of print.
- Derived from this study: PubMed 41453368Chavez-Badiola A, Mendizabal-Ruiz G, Flores-Saiffe Farias A, Costa-Borges N, Murray A, Alikani M, Silvestri G, Millan C, Hernandez-Morales E, Valencia-Murillo R, Medina V, Mestres E, Valadez Aguilar A, Ocegueda-Hernandez V, Acosta-Gomez F, Alvarez Lopez A, Acacio M, Matia-Algue Q, Espinoza Figueroa JG, Campos Olmedo LM, Barragan CP, Sanchez-Gonzalez DJ, Cohen J. Automated oocyte retrieval, denudation, sperm preparation, and ICSI in the IVF laboratory: a proof-of-concept study and report of the first live births. Hum Reprod. 2026 Feb 1;41(2):214-230. doi: 10.1093/humrep/deaf240.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). Data sharing is subject to ethical, legal, and privacy considerations. We are committed to following established guidelines and best practices for data sharing. This plan has been updated to provide more detailed information on access criteria.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamete preparation, ICSI, embryo culture and vitrification robot assistant and Routine Manual ICSI Workflow in people with Infertility, run by Conceivable Life Sciences at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Timing (time frame: 6 weeks from enrolment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074835, which also lists 2 linked publications.
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 20 Nov 2025.