Embryo DisorderNCT06279715
DFI and Aneuploidies
An observational study of Embryo Disorder, run by Clinique Ovo at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 to 43 years
- Conditions the study is for
- Embryo Disorder
- What is being tested?
- Preimplantation Genetic Testing for Aneuploidy
- How many people
- 537 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2024to 14 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- All sexes
- Adult
Study population: Data spreadsheet from October 2020 to December 2023 consisting of more than 800 medical charts.
Who may be able to join
- 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
Who cannot join
- Sperm donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Association Between the DNA Fragmentation Index (DFI) and the Frequency of Segmental and Total Aneuploidies
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.
- Conditions
- Embryo Disorder
- Being tested
- Preimplantation Genetic Testing for Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic Testing for AneuploidyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
DFI association and aneuploidy
Segmental aneuploidy is associated with high levels of sperm DNA fragmentation index
Measured: Up to 3 weeks after embryo fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start19 Jan 2024
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isaac-Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279715
- Sponsor's protocol ID
- 3437
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the DNA Fragmentation Index (DFI) and the Frequency of Segmental and Total Aneuploidies
- ClinicalTrials.gov ID
- NCT06279715
- Acronym / sponsor ID
- 3437
- Conditions
- Embryo Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- All
- Age groups
- Adult
- Study population
- Data spreadsheet from October 2020 to December 2023 consisting of more than 800 medical charts.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Sperm donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preimplantation Genetic Testing for AneuploidyPGT-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. | Other | – |
Primary outcome
DFI association and aneuploidy
Time frame: Up to 3 weeks after embryo fertilization
Segmental aneuploidy is associated with high levels of sperm DNA fragmentation index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac-Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Disorder, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFI association and aneuploidy (time frame: Up to 3 weeks after embryo fertilization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.