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NCT Number: NCT07364526

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

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.

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Key information

Conditions

IVF

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Instituto Bernabeu

Alicante, Spain

Location status: Recruiting

Location contact

BELEN LLEDO, PhD

CONTACT

[email protected]

965154053

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Live birth rate

    Time frame: 9 months from enrolment

Secondary outcomes

  1. Pregnancy rate

    Time frame: 2 weeks from enrolment

  2. Miscarriage rate

    Time frame: 12 weeks from enrollment

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study title

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

Acronym: niPGTAdon

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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