Interchromosomal Insertion Carriers PGT-SR
Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04978402
Collaborator
(none)
3
1
90
0
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.
Actual Study Start Date
:
Oct 1, 2011
Actual Primary Completion Date
:
Apr 1, 2019
Actual Study Completion Date
:
Apr 1, 2019
Outcome Measures
Primary Outcome Measures
- estimate the IT carrier's reproductive risk [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
- Adult patient whom carrying Insertional translocation in the context of PGT-SR management
Exclusion Criteria:
- Patient who reject the study protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uhmontpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: Izabel Bernicot, Ph.D, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04978402
Other Study ID Numbers:
- RECHMPL21_0486
First Posted:
Jul 27, 2021
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms: