跳至主要内容
临床试验/NCT06539104
NCT06539104招募中不适用

Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy Evaluated by Artificial Intelligence (SMARTAI Study)

Charles University, Czech Republic4 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
4
主要终点
The relative number of embryos whose ploidy was correctly predicted by AI

研究概览

简要总结

The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

详细描述

One of the main strategies of infertility treatment is in vitro fertilization (IVF). The IVF success rate is affected by several key factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. It has been suggested that the presence, position and retardance of the optically birefringent meiotic spindle (MS) are related to oocyte developmental competence, affecting the quality of fertilization and embryo development. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development.

Synergic approaches will be used to increase the quality of embryos for implantation: image analysis and machine learning techniques will be applied to the oocyte microscopic images to perform the MS analysis fully automatically and to determine whether some other aspects of the oocyte appearance might correlate with the optimal timing and fertilization and pregnancy success, or genetic defects. An automatic method of embryo evaluation based on time-lapse videos after ICSI and MS imaging plus other scalar parameters (extracted features can be used as inputs for the downstream tasks, e.g. features extracted from oocytes and sperm can serve as additional inputs to the embryo classifier) will be used. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

The analysis will be performed in cooperation with Czech Technical University and Institute of Physics Academy of Sciences of the Czech Republic who will create a software tool capable of predicting the probability of pregnancy and embryo ploidy status from oocyte images plus time-lapse video of a developing embryo after ICSI. It will be determined whether some other aspects of the oocyte appearance correlate with the fertilization and pregnancy success, or genetic defects.

Time lapse sequences of embryonic development and oocyte images will be acquired from VFN and from cooperating IVF centres (Gynem, s.r.o., Repromeda, s.r.o.). The sequences will be stored and paired with outcome (ploidy status, pregnancy) and also with previously acquired oocyte images. BIOCEV (Academy of sciences of the Czech Republic) will evaluate sperm parameters with respect to oocyte fertilization rate and early embryonic development.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Intracytoplasmatic Sperm Injection
  • Preimplantation genetic testing
  • Time lapse embryo record
  • Singned informed consent

排除标准

  • Gynecological diseases
  • Genetical diseases of parents

结局指标

主要结局

The relative number of embryos whose ploidy was correctly predicted by AI

时间窗: 1 hour

Using an AI based non-invasive method of selecting a high-quality and genetically healthy embryos will undoubtably improve clinical and diagnostic practice and reduce costs in the field of infertility treatment. Both the segmentation and classification training will be based on expert annotations. The approach should lead to a classification accuracy at least 70%.

次要结局

未报告次要终点

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaromír Mašata

Leading doctor of the Center of Urogynecology and Pelvic Recontructive Surgery

Charles University, Czech Republic

研究点 (4)

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