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NCT Number: NCT07197983

Automation of Oocyte and Embryo Vitrification

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.

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Key information

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cryosurvival

    Time frame: Within 14 days of egg retrieval

    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).

Secondary outcomes

  1. Procedural Timing

    Time frame: Within 14 days of egg retrieval.

    Time required to complete automated vs manual vitrification procedures

  2. Morphological Quality Assessment

    Time frame: Within 14 days of egg retrieval

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

  3. Technical Performance Metrics

    Time frame: Within 14 days of egg retrieval.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Giuseppe Silvestri, PhD

CONTACT

[email protected]

+44 7990960731

Sponsors and collaborators

Lead sponsor

Conceivable Life Sciences

Industry

Collaborators

  • CARE Fertility UK

Registry information

Official study title

Automation of Oocyte and Embryo Vitrification: a Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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