DFI and Aneuploidies

Embryo Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06279715
• Other study ID #: 3437
• Status: Active, not recruiting
• Start date: January 19, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: February 1, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• Embryo Disorder

Intervention

Other:
• Preimplantation 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.

Locations

Country	Name	City	State
Canada	Clinique ovo	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFI association and aneuploidy	Segmental aneuploidy is associated with high levels of sperm DNA fragmentation index	Up to 3 weeks after embryo fertilization