Automation of Oocyte and Embryo Vitrification

Conceivable Life Sciences

Status: Enrolling

Conditions: Infertility

Treatments: Device: Manual Vitrification; Device: Automated Vitrification

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07197983

10111748 (Other Grant/Funding Number)

CP003

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Automated Vitrification

Experimental group

Description:

Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level

Treatment:

Device: Automated Vitrification

Manual Vitrification

Active Comparator group

Description:

Oocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level

Treatment:

Device: Manual Vitrification