Automation of Oocyte and Embryo Vitrification

Официальное название

Automation of Oocyte and Embryo Vitrification: a Pilot Study

Обзор

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.

Вмешательства

• Устройство Automated Vitrification
  The PRESERVE-CR system performs automated vitrification (ultra-rapid freezing) of human oocytes and embryos using robotic manipulation and computer-controlled timing.
• Устройство Manual Vitrification
  Control specimens are vitrified by standard vitrification protocol.

Первичные конечные точки

• Cryosurvival [Срок оценки: Within 14 days of egg retrieval]

Вторичные конечные точки (3)

• Procedural Timing [Срок оценки: Within 14 days of egg retrieval.]
• Morphological Quality Assessment [Срок оценки: Within 14 days of egg retrieval]
• Technical Performance Metrics [Срок оценки: Within 14 days of egg retrieval.]

Критерии участия

Критерии включения

• BMI: Between 20-35 kg/m²
• Ovarian Reserve: Anti-Müllerian Hormone (AMH) ≥1.5 ng/mL

Критерии исключения

• Low ovarian reserve
• Surgical sperm retrieval required

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• CARE Fertility — Manchester

Идентификаторы

NCT: NCT07197983 · CP003 · 10111748

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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