Automation of Oocyte and Embryo Vitrification

NCT07197983 — Not applicable, Recruiting, 125 participants, Conceivable Life Sciences

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Automation of Oocyte and Embryo Vitrification: a Pilot Study

RegistryNCT07197983
StatusRecruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: single, other
Enrollment125 (Estimated)
SponsorConceivable Life Sciences (Industry); collaborators: CARE Fertility UK
ConditionsInfertility
InterventionsAutomated Vitrification, Manual Vitrification (Device)
Datesstart 2025-10-14, primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2025-09-30, last updated 2025-11-20
Locations1 site in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Infertility All trials of Automated Vitrification All trials of Manual Vitrification

-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Automated VitrificationExperimentalDevice: Automated VitrificationOocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level
Manual VitrificationActive comparatorDevice: Manual VitrificationOocytes/embryos from a particular donor will be randomized to manual or automated vitrification. There will be no randomization at the patient level
  • 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.

+Outcome measures

Primary outcomes

  • Cryosurvival [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

  • Procedural Timing [Within 14 days of egg retrieval.]: Time required to complete automated vs manual vitrification procedures
  • Morphological Quality Assessment [Within 14 days of egg retrieval]: Visual evaluation of egg/embryo structure and appearance post-thaw
  • Technical Performance Metrics [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).

+Eligibility

Sex: All, ages: 18 Years to 38 Years

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

+Locations (1)

FacilityCityCountryStatus
CARE FertilityManchesterUnited KingdomRecruiting