Infertility
Conditions
Brief 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. 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.
Interventions
DEVICEAutomated Vitrification
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
DEVICEManual Vitrification
Control specimens are vitrified by standard vitrification protocol.
Sponsors
CARE Fertility UK
Conceivable Life Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* BMI: Between 20-35 kg/m² * Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
Exclusion criteria
* Low ovarian reserve * Surgical sperm retrieval required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cryosurvival | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Timing | Within 14 days of egg retrieval. | Time required to complete automated vs manual vitrification procedures |
| Morphological Quality Assessment | Within 14 days of egg retrieval | Visual evaluation of egg/embryo structure and appearance post-thaw |
| Technical Performance Metrics | Within 14 days of egg retrieval. | 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). |
Countries
United Kingdom
Contacts
Primary ContactGiuseppe Silvestri, PhD
Outcome results
None listed