Non-invasive Preimplantation Genetic Screening (niPGTA) in Oocyte Donation Patients.
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
- 是
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
Belen Lledo
Director
Instituto Bernabeu
