NCT06279715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
537

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

July 31, 2025

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 16, 2024

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • DFI association and aneuploidy

    Segmental aneuploidy is associated with high levels of sperm DNA fragmentation index

    Up to 3 weeks after embryo fertilization

Interventions

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.

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Data spreadsheet from October 2020 to December 2023 consisting of more than 800 medical charts.

You may qualify if:

  • 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

You may not qualify if:

  • Sperm donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique ovo

Montreal, Quebec, H4P 2S4, Canada

Location

Study Officials

  • Isaac-Jacques Kadoch, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2024

First Posted

February 28, 2024

Study Start

January 19, 2024

Primary Completion

November 14, 2024

Study Completion

November 14, 2024

Last Updated

July 31, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations