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DFI and Aneuploidies

Evaluation of the Association Between the DNA Fragmentation Index (DFI) and the Frequency of Segmental and Total Aneuploidies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06279715
Enrollment
537
Registered
2024-02-28
Start date
2024-01-19
Completion date
2024-11-14
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Disorder

Brief summary

IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure. Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes.

Interventions

OTHERPreimplantation Genetic Testing for Aneuploidy

PGT-A typically involves the biopsy of three to eight cells from the developing embryo after approximately five days of culture. This technology also allows for the identification of segmentally aneuploid embryos.

Sponsors

Clinique Ovo
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 43 Years

Inclusion criteria

* IVF cycle completed at clinique ovo * Maternal age between 18 to 43 years included * PGT-A done on all embryos * Recent DFI within 1 year of the IVF cycle

Exclusion criteria

* Sperm donation

Design outcomes

Primary

MeasureTime frameDescription
DFI association and aneuploidyUp to 3 weeks after embryo fertilizationSegmental aneuploidy is associated with high levels of sperm DNA fragmentation index

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026