Automation of Oocyte and Embryo Vitrification
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated Vitrification, Manual Vitrification.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: 18 years — 38 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Automation of Oocyte and Embryo Vitrification: a Pilot Study
Overview
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
- Device Automated Vitrification
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing. - Device Manual Vitrification
Control specimens are vitrified by standard vitrification protocol.
Primary outcome measures
- Cryosurvival [Time frame: Within 14 days of egg retrieval]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United Kingdom · 1 center
- CARE Fertility — Manchester
Identifiers
NCT: NCT07197983 · CP003 · 10111748