UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057033 |
|---|---|
| Receipt number | R000065188 |
| Scientific Title | Establishment of Preimplantation Diagnosis of t(11;22) Translocation |
| Date of disclosure of the study information | 2025/02/14 |
| Last modified on | 2025/02/14 15:51:09 |
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Basic information
Public title
Establishment of preimplantation diagnosis for recurrent balanced translocation carriers
Acronym
Establishment of PGT for balanced translocation carriers
Scientific Title
Establishment of Preimplantation Diagnosis of t(11;22) Translocation
Scientific Title:Acronym
Establishment of PGT of t(11;22) Translocation
Region
| Japan |
Condition
Condition
Recurrent balanced translocation carrier
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Currently available PGT methods in Japan are unable to differentiate balanced reciprocal translocations from normal diploid embryos. However, distinguishing between these two is essential, as balanced translocation carriers may experience reproductive disorders or present with other disease phenotypes. In this study, we aimed to achieve this distinction by combining whole-genome amplification techniques with translocation-specific PCR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of balanced translocation embryos and normal diploid embryos.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Balanced reciprocal translocation carriers for t(8;22)(q24.13;q11.2) or t(11;22)(q23;q11.2)
Written informed consent for the experimental use of discarded embryos for which PGT-SR data were available
Discarded embryos that were unsuitable for transfer due to unbalanced translocations or translocation-unrelated aneuploidy
Key exclusion criteria
Other than the above
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kurahashi |
Organization
Center for Medical Science, Fujita Health University
Division name
Division of Molecular Genetics
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9391
kura@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Furukawa |
Organization
Center for Medical Science, Fujita Health University
Division name
Division of Molecular Genetics
Zip code
4701192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9391
Homepage URL
gen.furukawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-9391
gen.furukawa@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Discarded embryos deemed unsuitable for transfer due to unbalanced translocations or unrelated aneuploidies undergo multiple whole-genome amplification methods and translocation-specific PCR to identify the derivative chromosomes resulting from the translocation.
Management information
Registered date
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065188
