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临床试验/NCT07076719
NCT07076719已完成不适用

Cell-free DNA Analysis of Spent Embryo Culture Media as a Non-invasive Approach for Preimplantation Genetic Diagnosis

Sohag University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

This study aims to evaluate the feasibility and accuracy of using cfDNA analysis of spent embryo culture media as a non-invasive approach for PGD. Specifically, the objectives of the study are:

  1. To collect SCM from blastocysts of good quality obtained from IVF cycles.
  2. To extract cfDNA from the collected SCM using a commercially available kit.
  3. To assess the chromosomal content in both cfDNA and gDNA samples via array-based comparative genomic hybridization (aCGH).
  4. To compare the results obtained using cfDNA analysis to those obtained using conventional invasive PGD methods, such as blastomere biopsy.
  5. To evaluate the potential advantages of using cfDNA analysis of spent embryo culture media for PGD, including reduced risk of harm to the embryo, reduced cost, and increased efficiency.

详细描述

Materials and Methods:

  1. Study Design
  • Type of Study: This is a retrospective study.

  • Location: The study was conducted at the Assisted Reproductive Technology Unit Life Zena Center, Baghdad, Baghdad Governorate, Iraq.

  • Duration: The study was conducted from October 2023 to August 2024.

  • Patient Criteria:

  • Included: All patients referred for PGT-A.

  • Excluded: Patients who had no blastocyst for biopsy were excluded.

  • Ethical Approval: The study was approved by the Committee for the Scientific Research Ethics of Sohag University (CSRE-16-24).

  1. Ovarian Stimulation and Oocyte Retrieval

• Protocols: Patients underwent controlled ovarian stimulation using either:

研究设计

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

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •All patients referred for PGT-A.

排除标准

  • •Patients who had no blastocyst for biopsy were excluded

结局指标

主要结局

Diagnostic accuracy

时间窗: 12 moponths

Accuracy of using cfDNA analysis of spent embryo culture media as a non-invasive approach for PGD in comparison to traditional trophectoderm biopsy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatem Awaga

Assistant Professor of Obstetrics and Gynecology

Sohag University

研究点 (1)

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