Recruiting

PGT-A

Sponsor:

Shady Grove Fertility Reproductive Science Center

Code:

NCT07227116

Conditions

Complex Aneuploidy

Chaotic Aneuploidy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07227116

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

280 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Reproducibility [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Benjamin S Harris, MD, MPH

benjamin.harris@sgfertility.com

Locations

IVF Florida Reproductive Associates

Recruiting

Margate, Florida, United States, 33063

Contacts

Kathy Miller, PhD, HCLD

3015451423

Shady Grove Fertility

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Fertility Center of Illinois

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Shady Grove Fertility

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Shady Grove Fertility

Recruiting

Towson, Maryland, United States, 33607

Contacts

Shady Grove Fertility

Recruiting

Cary, North Carolina, United States, 27519

Contacts

Shady Grove Fertility

Recruiting

Cary, North Carolina, United States, 27519

Contacts

Shady Grove Fertility

Recruiting

Chesterbrook, Pennsylvania, United States, 19087

Contacts

Shady Grove Fertility

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Shady Grove Fertility

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Shady Grove Fertility

Recruiting

Richmond, Virginia, United States, 23235

Contacts

More Information

Sponsor

Shady Grove Fertility Reproductive Science Center

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • Chaotic, Complex, Aneuploidies, Embryos

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shady Grove Fertility Reproductive Science Center on 2025-11-12.