NCT07364526

Non-Invasive Preimplantation Genetic Screening for Aneuploidies and Clinical Outcomes in Egg Donation Patients

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 164 (estimated)
• Sponsor: Instituto Bernabeu · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• IVF

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-03-01
• Completion: 2027-12-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Spain