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NCT04978402 Clinical Trial

Interchromosomal Insertion Carriers PGT-SR

Infertility Clinical Trial

Official title:
Management of Insertional Translocation Carriers for Preimplantation Genetic Testing and the Relevance of Sperm Analysis for Reproductive Risk Estimation.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04978402
Other study ID # RECHMPL21_0486
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2011
Est. completion date April 1, 2019

Study information
Verified date July 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 3
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria: - Adult patient whom carrying Insertional translocation in the context of PGT-SR management Exclusion Criteria: - Patient who reject the study protocol

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 day 1
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