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临床试验/NCT07364526
NCT07364526招募中不适用

Non-invasive Preimplantation Genetic Screening (niPGTA) in Oocyte Donation Patients.

Instituto Bernabeu1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2026年2月26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
164
试验地点
1
主要终点
Live birth rate

研究概览

简要总结

Preimplantation genetic testing for aneuploidies (PGT-A) is commonly used in IVF but requires embryo biopsy and shows limited benefit in egg donation cycles. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA in spent culture media, offers a promising biopsy-free alternative. This prospective, blinded study in egg donation cycles will evaluate whether niPGTA-detected aneuploidy is associated with implantation failure and pregnancy loss, assessing its potential clinical value as a non-invasive embryo selection tool.

详细描述

Preimplantation genetic testing for aneuploidies (PGT-A) is widely used in IVF to improve embryo selection and pregnancy outcomes. However, it requires invasive embryo biopsy and has not shown clear benefit in egg donation cycles, where embryos originate from young donors with lower aneuploidy rates. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA released into the culture medium, represents a promising alternative that avoids embryo biopsy.

This prospective, blinded, non-selection study will include women undergoing egg donation treatment. Embryos will be selected for transfer using standard morphological criteria only, while niPGTA results will not influence clinical decisions. After embryo transfer, the spent culture medium will be collected and analyzed using next-generation sequencing to determine the presence of chromosomal aneuploidies.

The study aims to evaluate whether aneuploidy detected by niPGTA is associated with implantation failure, biochemical pregnancy loss, and clinical miscarriage. By comparing niPGTA results between embryos that result in pregnancy and those that do not, this project will assess the potential clinical value of niPGTA as a non-invasive embryo selection tool in egg donation cycles.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women between 18 and 50 years old who are oocyte recipients.
  • Signed consent form
  • Transfer of a single blastocyst-stage embryo
  • Male with normal sperm FISH

排除标准

  • Uterine malformations
  • Abnormal karyotypes in either partner
  • Failure to sign informed consent

结局指标

主要结局

Live birth rate

时间窗: 9 months from enrolment

次要结局

  • Pregnancy rate(2 weeks from enrolment)
  • Miscarriage rate(12 weeks from enrollment)

研究者

发起方
Instituto Bernabeu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Belen Lledo

Director

Instituto Bernabeu

研究点 (1)

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