Automation of Oocyte and Embryo Vitrification

ConditionInfertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-38
SponsorConceivable Life Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI: Between 20-35 kg/m²

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

Disqualifiers

Low ovarian reserve

Surgical sperm retrieval required

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

125 Participants
are divided into 2 treatment groups
Group A: Automated VitrificationExperimental treatment 1 intervention
Group B: Manual VitrificationActive comparator 1 intervention

Trial outcomes

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).

Time frame
Within 14 days of egg retrieval

Secondary outcomes

1

Procedural Timing

Time required to complete automated vs manual vitrification procedures

Time frame
Within 14 days of egg retrieval.
2

Morphological Quality Assessment

Visual evaluation of egg/embryo structure and appearance post-thaw

Time frame
Within 14 days of egg retrieval
3

Technical Performance Metrics

Level of autonomy achieved (percentage of procedures completed without operator intervention outside of UI input). Operator assistance (frequency and type of manual interventions, if any). Success rates of specific robotic actions (picking, placing, plunging).

Time frame
Within 14 days of egg retrieval.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Conceivable Life Sciences

Lead sponsor

CARE Fertility UK

Collaborator