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Automation of Oocyte and Embryo Vitrification: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 38
Healthy Volunteers: f
View:

• BMI: Between 20-35 kg/m²

• Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL

Locations
Other Locations
United Kingdom
CARE Fertility
RECRUITING
Manchester
Contact Information
Primary
Giuseppe Silvestri, PhD
giuseppe@conceivable.life
+44 7990960731
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 125
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: CARE Fertility UK
Leads: Conceivable Life Sciences

This content was sourced from clinicaltrials.gov