Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
125 participants
INTERVENTIONAL
2025-10-14
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Automated Vitrification
Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level
Automated Vitrification
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
Manual Vitrification
Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level
Manual Vitrification
Control specimens are vitrified by standard vitrification protocol.
Interventions
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Automated Vitrification
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
Manual Vitrification
Control specimens are vitrified by standard vitrification protocol.
Eligibility Criteria
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Inclusion Criteria
* Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
Exclusion Criteria
* Surgical sperm retrieval required
18 Years
38 Years
ALL
No
Sponsors
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CARE Fertility UK
OTHER
Conceivable Life Sciences
INDUSTRY
Responsible Party
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Locations
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CARE Fertility
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10111748
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CP003
Identifier Type: -
Identifier Source: org_study_id
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