Automation of Oocyte and Embryo Vitrification

Sponsor
Conceivable Life Sciences
Study ID
NCT07197983
Status
Recruiting
Apply to this trial

Conditions

  • Infertility

Eligibility Criteria

Sex
ALL
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • Automated Vitrification — DEVICE
    The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
  • Manual Vitrification — DEVICE
    Control specimens are vitrified by standard vitrification protocol.

Study Details

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.

Key Dates

First listed
Sep 30, 2025
Start date
Oct 14, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
125 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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
  • Active Comparator: 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

Primary Outcome Measure

Cryosurvival [ Time Frame: Within 14 days of egg retrieval ]

Central Contacts

Related Studies