Re-checking embryos labeled complex or chaotic aneuploid to find transferable embryos
ESCALATE: Evaluating the Status of Complex Aneuploidy to Locate Additional Transferrable Embryos
Shady Grove Fertility Reproductive Science Center · NCT07227116
This project tries re-biopsy and genetic reanalysis of embryos labeled complex or chaotic aneuploid to see if any have normal chromosomes and could be candidates for transfer for people with such embryos.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 280 (estimated) |
| Sex | All |
| Sponsor | Shady Grove Fertility Reproductive Science Center (other) |
| Locations | 12 sites (Margate, Florida and 11 other locations) |
| Trial ID | NCT07227116 on ClinicalTrials.gov |
What this trial studies
This observational protocol performs re-biopsy and next-generation sequencing PGT-A reanalysis on embryos previously reported as complex (≥3 aneuploid chromosomes) or chaotic (≥6 aneuploid chromosomes). Consent covers only the re-biopsy and genetic testing procedures and does not include consent for embryo transfer. The goal is to determine whether some embryos initially called complex or chaotic might show corrected or normal chromosomal results on repeat testing. Participants must have at least one qualifying embryo stored at a participating clinic and participation is voluntary with no impact on clinical care.
Who should consider this trial
Good fit: People who have at least one embryo previously classified as complex (three or more whole-chromosome aneuploidies) or chaotic (six or more aneuploidies) on NGS-based PGT-A and who consent to re-biopsy and reanalysis are eligible.
Not a fit: Patients without embryos meeting the complex/chaotic criteria or whose embryos remain abnormal on reanalysis are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, re-biopsy and reanalysis could identify embryos initially labeled complex or chaotic that actually have normal chromosomes and might be suitable for transfer.
How similar studies have performed: There is at least one published case report of a healthy live birth after transfer of a chaotic embryo, but larger-scale evidence is very limited and the approach remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having ≥ 1 embryo classified as whole chromosome chaotic or complex aneuploid of 3 or more chromosomes following preimplantation genetic testing for aneuploidy using an NGS based platform Signed informed consent Exclusion Criteria: * Embryos not meeting complex/chaotic criteria Patients declining consent
Where this trial is running
Margate, Florida and 11 other locations
- IVF Florida Reproductive Associates — Margate, Florida, United States (RECRUITING)
- Shady Grove Fertility — Atlanta, Georgia, United States (RECRUITING)
- Fertility Center of Illinois — Highland Park, Illinois, United States (RECRUITING)
- Shady Grove Fertility — Rockville, Maryland, United States (RECRUITING)
- Shady Grove Fertility — Towson, Maryland, United States (RECRUITING)
- Shady Grove Fertility — Cary, North Carolina, United States (RECRUITING)
- Shady Grove Fertility — Cary, North Carolina, United States (RECRUITING)
- Shady Grove Fertility — Chesterbrook, Pennsylvania, United States (RECRUITING)
- Shady Grove Fertility — Fairfax, Virginia, United States (RECRUITING)
- Shady Grove Fertility — Norfolk, Virginia, United States (RECRUITING)
- Shady Grove Fertility — Richmond, Virginia, United States (RECRUITING)
- SGFertility Chile Medicina Reproductiva — Santiago, Santiago Metropolitan, Chile (RECRUITING)
Study contacts
- Principal investigator: Benjamin S Harris, MD, MPH — Shady Grove Fertility
- Study coordinator: SGF Research Team SGF Research Team
- Email: SGFClinicalResearchTeam@sgfertility.com
- Phone: (301) 545-1423
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.
Conditions: Complex Aneuploidy, Chaotic Aneuploidy, Chaotic, Complex, Aneuploidies, Embryos