Automation of Oocyte and Embryo Vitrification

NCT ID: NCT07197983

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A single cohort of patients undergoing IVF/ICSI treatment has their spare eggs and embryos (those not suitable for treatment) divided for parallel assignment to two study arms. Each patient's samples are split, with some assigned to automated vitrification using the PRESERVE-CR system and some assigned to standard manual vitrification. This parallel design using sibling samples allows direct comparison of the two methods while controlling for patient-specific factors.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Automated Vitrification

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Manual Vitrification

Intervention Type DEVICE

Control specimens are vitrified by standard vitrification protocol.

Interventions

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Automated Vitrification

The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.

Intervention Type DEVICE

Manual Vitrification

Control specimens are vitrified by standard vitrification protocol.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CARE Fertility UK

OTHER

Sponsor Role collaborator

Conceivable Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CARE Fertility

Manchester, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Giuseppe Silvestri, PhD

Role: CONTACT

+44 7990960731

Facility Contacts

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Tom Bamford, MD, PhD

Role: primary

+44 (0) 800 564 2270

Other Identifiers

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10111748

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CP003

Identifier Type: -

Identifier Source: org_study_id

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