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Polygenic Embryo Selection

2026年9月21日 更新者:Nucleus Genomics Inc.

Prospective Observational Outcome Comparison of Morphology- Versus Polygenic-Based Selection of In Vitro Fertilization-Derived Embryos

This study will evaluate whether IVF success rates after PRS-based embryo selection differ from those after morphology-based embryo selection, and whether polygenic disease risk correlates with embryo morphology.

研究概览

地位

尚未招聘

详细说明

Conventional IVF involves the use of morphological grading, commonly using Gardner scores, to prioritize embryos for transfer. Morphological grading is a well established method to improve implantation rates, with better morphological scored embryos having a higher success than lower scoring embryos. Morphology-based selection is also employed following preimplantation genetic testing for aneuploidy (PGT-A), which is now used in over 60% of all IVF cycles in the United States.

More recently, polygenic scoring (PRS) of embryos has been introduced to provide additional information on disease risks and trait probabilities, allowing patients to utilize an alternative method of embryo selection. While there is no prospective study evaluating the utility of PRS, longitudinal studies on over 20,000 sibling pairs and on millions of adults have demonstrated significant disease risk reduction.

One common concern over the use of PRS in place of morphology based selection is the potential impact of implantation and delivery rates. For example, in some cases, the embryo with the lowest risk of a disease may not be the best morphology in the cohort of embryos available for transfer. The question of whether genetic based selection results in lower success rates than morphology based selection has not been evaluated in a prospective observational study. Some retrospective data exist in the context of sex selection. For example, patients using PGT-A may decide to transfer an embryo with their preferred sex (male or female) instead of choosing based on morphology alone. One such study indicated no significant difference in delivery rates between sex and morphology based selection. While this outcome remains surprising to many, one factor that is not always considered is that genetic selection does not always lead to transferring an embryo with the worst morphology. However, similar studies have not been published to corroborate these findings.

This study will evaluate whether IVF success rates after PRS based embryo selection are different from morphology based embryo selection and whether polygenic disease risk is correlated with embryo morphology.

研究类型

观察性的

注册 (估计的)

2000

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Cases (PRS): IVF patients/couples (intended parents) who elect to use PRS based embryo selection.

Controls (Morphology): IVF patients/couples (intended parents) who elect to use morphology based embryo selection.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Undergoing IVF and PGT at any clinic where Nucleus testing is used.
  • Ability to provide informed consent and HIPAA authorization

Exclusion Criteria:

  • Patients who decline research use of data

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
IVF patients using preimplantation genetic testing

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sustained Implantation Rate
大体时间:From enrollment to the end of treatment at 8-12 weeks

Ongoing pregnancy rate per embryo transfer at the time of discharge from IVF care

From enrollment to the end of treatment at 8-12 weeks

次要结果测量

结果测量
措施说明
大体时间
Polygenic Score correlation with Embryo Morphology
大体时间:Through study completion (3 years)

Comparison of Disease Risk Scores According to Embryo Morphological Grades

Through study completion (3 years)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2029年9月30日

研究完成 (估计的)

2029年9月30日

研究注册日期

首次提交

2026年9月16日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月25日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro04078746

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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