Evaluating the Status of Complex Aneuploidy to Locate Additional Transferrable Embryos

NCT07227116 | Recruiting

• 1 other identifier: 20250101
• Study Type: observational
• Target: 280
• Locations: 2 countries
• Sites: 12

Brief Summary

This study aims to evaluate the reproductive potential of embryos classified as "complex aneuploid" (involving three or more abnormal chromosomes) or "chaotic" (six or more abnormal chromosomes) through preimplantation genetic testing for aneuploidy (PGT-A). Specifically, we seek to determine whether embryos initially reported as having multiple chromosomal abnormalities might still have the potential for normal chromosomal composition, the opportunity for transfer, and ultimately, the potential to achieve a live birth through re-biopsy and reanalysis. Key Information: This portion of the study seeks your consent for the re-biopsy and genetic reanalysis of the embryos only. It does not yet include consent for potential future transfer. Participation remains completely voluntary, and your decision will not affect your current or future care. We deeply appreciate your support and commitment to advancing fertility research.

Conditions

Complex Aneuploidy; Chaotic Aneuploidy

Keywords

Chaotic, Complex, Aneuploidies, Embryos

Outcome Measures

Primary Outcomes (1)

• Reproducibility

  To evaluate embryos with 3 or more chromosomes deemed aneuploid with NGS-based PGT-A by performing repeat biopsy and analyzing with NGS.

  one year

Study Arms (1)

Multiple Aneuploidy Embryos

Embryos identified by PGT-A as having multiple chromosomal aneuploidies. DNA from trophectoderm re-biopsy samples will be retained by the testing laboratory for confirmatory analysis and quality control under IRB-approved protocols.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with one or more embryos in storage that meet criteria for Chaotic or Complex Aneuploidy by PGT-A with NGS

You may qualify if:

• 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

You may not qualify if:

• Embryos not meeting complex/chaotic criteria Patients declining consent

Sponsors & Collaborators

• Shady Grove Fertility Reproductive Science Center: lead

Study Sites (12)

IVF Florida Reproductive Associates

Margate, Florida, 33063, United States

RECRUITING

Shady Grove Fertility

Atlanta, Georgia, 30342, United States

RECRUITING

Fertility Center of Illinois

Highland Park, Illinois, 60035, United States

RECRUITING

Shady Grove Fertility

Rockville, Maryland, 20850, United States

RECRUITING

Shady Grove Fertility

Towson, Maryland, 33607, United States

RECRUITING

Shady Grove Fertility

Cary, North Carolina, 27519, United States

RECRUITING

Shady Grove Fertility

Cary, North Carolina, 27519, United States

RECRUITING

Shady Grove Fertility

Chesterbrook, Pennsylvania, 19087, United States

RECRUITING

Shady Grove Fertility

Fairfax, Virginia, 22031, United States

RECRUITING

Shady Grove Fertility

Norfolk, Virginia, 23507, United States

RECRUITING

Shady Grove Fertility

Richmond, Virginia, 23235, United States

RECRUITING

SGFertility Chile Medicina Reproductiva

Santiago, Santiago Metropolitan, 7630000, Chile

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be retained by the testing laboratory for quality control and confirmatory testing under IRB-approved protocols. No identifiable genetic material will be stored or used for future research beyond this study without additional consent.

MeSH Terms

Conditions

Aneuploidy

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kate Devine, MD

  Shady Grove Fertility

  STUDY DIRECTOR

• Benjamin S Harris, MD, MPH

  Shady Grove Fertility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SGF Research Team SGF Research Team

CONTACT

(301) 545-1423; SGFClinicalResearchTeam@sgfertility.com

Benjamin S Harris, MD, MPH

CONTACT

benjamin.harris@sgfertility.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: November 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (11); CL (1)