Automation of Oocyte and Embryo Vitrification
2 other identifiers
interventional
125
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 30, 2025
CompletedStudy Start
First participant enrolled
October 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
November 20, 2025
November 1, 2025
9 months
September 25, 2025
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Within 14 days of egg retrieval
Secondary Outcomes (3)
Procedural Timing
Within 14 days of egg retrieval.
Morphological Quality Assessment
Within 14 days of egg retrieval
Technical Performance Metrics
Within 14 days of egg retrieval.
Study Arms (2)
Automated Vitrification
EXPERIMENTALOocytes/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 COMPARATOROocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level
Interventions
The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
Control specimens are vitrified by standard vitrification protocol.
Eligibility Criteria
You may qualify if:
- BMI: Between 20-35 kg/m²
- Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL
You may not qualify if:
- Low ovarian reserve
- Surgical sperm retrieval required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Conceivable Life Scienceslead
- CARE Fertility UKcollaborator
Study Sites (1)
CARE Fertility
Manchester, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2025
First Posted
September 30, 2025
Study Start
October 14, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 months and ending 36 months following article publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. Proposals should be directed to PI@Conceivable.life; to gain access, data requestors will need to sign a data access agreement.
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.