Interchromosomal BreakpointNCT04978402
Interchromosomal Insertion Carriers PGT-SR
An observational study of Interchromosomal Breakpoint and Infertility, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interchromosomal Breakpoint, Infertility
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2011to 1 Apr 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis.
Who may be able to join
- Adult patient whom carrying Insertional translocation in the context of PGT-SR management
Who cannot join
- Patient who reject the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.
Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. However, the meiotic segregation of IT has rarely been studied. This study provide an accurate reproductive risk of IT carriers resulting from a combined analysis of Sperm-FISH and preimplantation genetic testing for structural rearrangement (PGT-SR) management of IT carriers.
- Conditions
- Interchromosomal Breakpoint, Infertility
- Keywords
- Patients carriers of Insertional translocation (IT), Several years of miscarriages, Abrotions and primary infertility, Interchromosomal insertion, PGT-SR, Sperm.
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate the IT carrier's reproductive risk
estimate the IT carrier's reproductive risk by investigation of the meiotic segregation of sperm from IT carriers by FISH and evaluate PGT-SR results of male and female IT carriers
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Oct 2011
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interchromosomal BreakpointStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izabel Bernicot, Ph.D, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978402
- Sponsor's protocol ID
- RECHMPL21_0486
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.
- ClinicalTrials.gov ID
- NCT04978402
- Acronym / sponsor ID
- RECHMPL21_0486
- Conditions
- Interchromosomal Breakpoint, Infertility
- Keywords
- Patients carriers of Insertional translocation (IT), Several years of miscarriages, Abrotions and primary infertility, Interchromosomal insertion, PGT-SR, Sperm.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 27 Jul 2021 (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.
Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. However, the meiotic segregation of IT has rarely been studied. This study provide an accurate reproductive risk of IT carriers resulting from a combined analysis of Sperm-FISH and preimplantation genetic testing for structural rearrangement (PGT-SR) management of IT carriers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis.
Key inclusion criteria (1 listed)
- Adult patient whom carrying Insertional translocation in the context of PGT-SR management
Key exclusion criteria (1 listed)
- Patient who reject the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
estimate the IT carrier's reproductive risk
Time frame: day 1
estimate the IT carrier's reproductive risk by investigation of the meiotic segregation of sperm from IT carriers by FISH and evaluate PGT-SR results of male and female IT carriers
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 27 Jul 2021.
- Individual participant dataSharing planned: Undecided. NC
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.
Izabel Bernicot, Ph.D principal investigator
University Hospital, Montpellier
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 Interchromosomal Breakpoint and Infertility, run by University Hospital, Montpellier at 1 site in France.
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 1 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 27 Jul 2021. 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 France. 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?
estimate the IT carrier's reproductive risk (time frame: day 1). 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 27 Jul 2021.