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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07364526
Acronym
niPGTAdon
Enrollment
164
Registered
2026-01-23
Start date
2026-02-26
Completion date
2027-12-01
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF

Keywords

niPGTA

Brief 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.

Interventions

None listed

Sponsors

Instituto Bernabeu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Live birth rate9 months from enrolment

Secondary

MeasureTime frame
Pregnancy rate2 weeks from enrolment
Miscarriage rate12 weeks from enrollment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026