Non-invasive embryo genetic screening in egg donation cycles
Non-invasive Preimplantation Genetic Screening (niPGTA) in Oocyte Donation Patients.
This will test whether a non-invasive genetic test of the embryo culture fluid can predict implantation and pregnancy outcomes for people receiving donated eggs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Instituto Bernabeu Academic / other |
| Locations | 1 site (Alicante) |
| Trial ID | NCT07364526 on ClinicalTrials.gov |
What this trial studies
This is a prospective, blinded, non-selection study in women receiving donor oocytes who undergo single blastocyst transfer. Embryos will be chosen for transfer using standard morphological criteria only, and the spent culture medium will be collected without influencing clinical decisions. Cell-free embryonic DNA in the spent medium will be analyzed by next-generation sequencing to detect chromosomal aneuploidies (niPGTA). The study will compare niPGTA results from transferred embryos that implant or lead to ongoing pregnancy versus those that fail to implant or result in pregnancy loss.
Who should consider this trial
Good fit: Ideal candidates are oocyte recipients aged 18–50 planning a single blastocyst transfer with a partner who has normal sperm FISH and who can give informed consent.
Not a fit: Patients with uterine malformations, abnormal parental karyotypes, or those not undergoing single blastocyst donor transfers (or who cannot consent) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could allow clinicians to identify embryos at higher risk of implantation failure or miscarriage without performing an invasive embryo biopsy.
How similar studies have performed: Other studies of non-invasive PGT‑A have shown mixed results, with some promising concordance but variable reliability, so its clinical value in egg donation cycles remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Alicante
- Instituto Bernabeu — Alicante, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.