InfertilityNCT07197983
Automation of Oocyte and Embryo Vitrification
A study testing Automated Vitrification and Manual Vitrification in people with Infertility, run by Conceivable Life Sciences at 1 site in United Kingdom.
Trial summary
Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff. Background: Currently, freezing eggs and embryos during fertility treatments (IVF/ICSI) is done entirely by hand by skilled embryologists. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Infertility
- What is being tested?
- Automated Vitrification and Manual Vitrification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2025to 30 Jun 2026
- 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 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI: Between 20-35 kg/m²
- Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
Who cannot join
- Low ovarian reserve
- Surgical sperm retrieval required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
CARE Fertility
Manchester
Tom Bamford, MD, PhD, +44 (0) 800 564 2270, Tom.Bamford@carefertility.com
About this study
Official title: Automation of Oocyte and Embryo Vitrification: a Pilot Study
Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff.
Background: Currently, freezing eggs and embryos during fertility treatments (IVF/ICSI) is done entirely by hand by skilled embryologists. This manual process is time-consuming, requires extensive training, and outcomes can vary between different staff members. Automating this process could help standardize procedures, reduce costs, and potentially make fertility treatments more accessible to patients.
Read more
What is Being Tested: The study will compare an automated freezing system (prototype designation PRESERVE-CR) against the standard manual freezing method. The key research question is: Can the automated system preserve eggs and embryos as successfully as experienced embryologists do by hand?
How It Works: Patients undergoing IVF/ICSI treatment at CARE Fertility Manchester who consent to participate will have their surplus eggs and embryos (those not suitable for their treatment) divided into two groups. Some will be frozen using the traditional manual method, and some using the new automated system. Both groups will then be thawed to measure survival rates. Tests do not encompass any reproductive outcomes or the creation of embryos specifically for this research.
Why This Matters: If successful, automated freezing could help reduce the workload on laboratory staff, standardize the freezing process across different clinics, potentially lower treatment costs, and make fertility treatments available to more people who need them. The study only uses oocytes and embryos which are unsuitable for patient treatment and that would otherwise be discarded, ensuring no impact on participants' actual fertility treatment.
- Conditions
- Infertility
- Being tested
- Automated Vitrification, Manual Vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated VitrificationDevice
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
Manual VitrificationDevice
Control specimens are vitrified by standard vitrification protocol.
| Study group | Role | What they receive |
|---|---|---|
| Automated Vitrification | Experimental | Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level Receives: Device: Automated Vitrification |
| Manual Vitrification | Active comparator | Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level Receives: Device: Manual Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryosurvival
The proportion of eggs and embryos that survive the freezing and thawing process when using the PRESERVE-CR automated system compared to manual vitrification (sibling controls).
Measured: Within 14 days of egg retrieval
Secondary outcomes (3)
Procedural Timing
Time required to complete automated vs manual vitrification procedures
Measured: Within 14 days of egg retrieval.
Morphological Quality Assessment
Visual evaluation of egg/embryo structure and appearance post-thaw
Measured: Within 14 days of egg retrieval
Technical Performance Metrics
Level of autonomy achieved (percentage of procedures completed without operator intervention outside of UI input). Operator assistance (frequency and type of manual interventions, if any). Success rates of specific robotic actions (picking, placing, plunging).
Measured: Within 14 days of egg retrieval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start14 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A single cohort of patients undergoing IVF/ICSI treatment has their spare eggs and embryos (those not suitable for treatment) divided for parallel assignment to two study arms. Each patient's samples are split, with some assigned to automated vitrification using the PRESERVE-CR system and some assigned to standard manual vitrification. This parallel design using sibling samples allows direct comparison of the two methods while controlling for patient-specific factors.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conceivable Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CARE Fertility UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197983
- Sponsor's protocol ID
- CP003
- Other IDs
- 10111748
- Status last verified
- Nov 2025
- First submitted
- 25 Sep 2025
- 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 an 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.
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 Oocyte and Embryo Vitrification: a Pilot Study
- ClinicalTrials.gov ID
- NCT07197983
- Acronym / sponsor ID
- CP003
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Conceivable Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- CARE Fertility UK
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Sep 2025 (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.
Purpose: This study aims to test whether a new automated system can freeze human eggs and embryos as effectively as the current manual method performed by laboratory staff.
Background: Currently, freezing eggs and embryos during fertility treatments (IVF/ICSI) is done entirely by hand by skilled embryologists. This manual process is time-consuming, requires extensive training, and outcomes can vary between different staff members. Automating this process could help standardize procedures, reduce costs, and potentially make fertility treatments more accessible to patients.
What is Being Tested: The study will compare an automated freezing system (prototype designation PRESERVE-CR) against the standard manual freezing method. The key research question is: Can the automated system preserve eggs and embryos as successfully as experienced embryologists do by hand?
How It Works: Patients undergoing IVF/ICSI treatment at CARE Fertility Manchester who consent to participate will have their surplus eggs and embryos (those not suitable for their treatment) divided into two groups. Some will be frozen using the traditional manual method, and some using the new automated system. Both groups will then be thawed to measure survival rates. Tests do not encompass any reproductive outcomes or the creation of embryos specifically for this research.
Why This Matters: If successful, automated freezing could help reduce the workload on laboratory staff, standardize the freezing process across different clinics, potentially lower treatment costs, and make fertility treatments available to more people who need them. The study only uses oocytes and embryos which are unsuitable for patient treatment and that would otherwise be discarded, ensuring no impact on participants' actual fertility treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single cohort of patients undergoing IVF/ICSI treatment has their spare eggs and embryos (those not suitable for treatment) divided for parallel assignment to two study arms. Each patient's samples are split, with some assigned to automated vitrification using the PRESERVE-CR system and some assigned to standard manual vitrification. This parallel design using sibling samples allows direct comparison of the two methods while controlling for patient-specific factors.
| Arm | Type | Receives |
|---|---|---|
| Automated Vitrification | Experimental | Device: Automated VitrificationOocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level |
| Manual Vitrification | Active comparator | Device: Manual VitrificationOocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: Between 20-35 kg/m²
- Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
Key exclusion criteria (2 listed)
- Low ovarian reserve
- Surgical sperm retrieval required
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 |
|---|---|---|
| Automated VitrificationThe PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing. | Device | Automated Vitrification |
| Manual VitrificationControl specimens are vitrified by standard vitrification protocol. | Device | Manual Vitrification |
Primary outcome
Cryosurvival
Time frame: Within 14 days of egg retrieval
The proportion of eggs and embryos that survive the freezing and thawing process when using the PRESERVE-CR automated system compared to manual vitrification (sibling controls).
3 secondary outcomes
Procedural Timing
Time frame: Within 14 days of egg retrieval.
Morphological Quality Assessment
Time frame: Within 14 days of egg retrieval
Technical Performance Metrics
Time frame: Within 14 days of egg retrieval.
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 20 Nov 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in an 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Vitrification and Manual Vitrification in people with Infertility, run by Conceivable Life Sciences at 1 site in United Kingdom.
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 2 inclusion and 2 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: looking for participants now, 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 United Kingdom. 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?
Contact Giuseppe Silvestri, PhD (+44 7990960731, giuseppe@conceivable.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cryosurvival (time frame: Within 14 days of egg retrieval). 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 20 Nov 2025.