Re-checking embryos labeled complex or chaotic aneuploid to find transferable embryos
Official title: ESCALATE: Evaluating the Status of Complex Aneuploidy to Locate Additional Transferrable Embryos
Run by Shady Grove Fertility Reproductive Science Center · NCT07227116 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Shady Grove Fertility Reproductive Science Center Academic / other |
| Locations | 12 sites (Margate, Florida and 11 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | April 2026 |
| Study ends | June 2026 |
| Registry record updated | November 12, 2025 |
| Trial ID | NCT07227116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 6 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.