UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056569 |
|---|---|
| Receipt number | R000064649 |
| Scientific Title | PGT-M for Myotonic Dystrophy Type 1 |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/25 21:50:22 |
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Basic information
Public title
PGT-M for Myotonic Dystrophy Type 1
Acronym
PGT-M for Myotonic Dystrophy Type 1
Scientific Title
PGT-M for Myotonic Dystrophy Type 1
Scientific Title:Acronym
PGT-M for Myotonic Dystrophy Type 1
Region
| Japan |
Condition
Condition
Myotonic Dystrophy Type 1
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Research and development for PGT-M for Myotonic Dystrophy Type 1
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Embryo diagnosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Gene |
Interventions/Control_1
Embryo transfer after PGT-M
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Single patient
Key exclusion criteria
NA
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Mariya |
Organization
Sapporo Medical University of Medicine
Division name
Obstetrics and Gynecology
Zip code
060-8556
Address
South 1 West 17, Chuo Ku, Sapporo
TEL
01-611-2111
mariya.tasuku@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Mariya |
Organization
Sapporo Medical University of Medicine
Division name
Obstetrics and Gynecology
Zip code
060-8556
Address
South 1 West 17, Chuo Ku, Sapporo
TEL
011-611-2111
Homepage URL
mariya.tasuku@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University of Medicine
Institute
Department
Personal name
Funding Source
Organization
NA
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
Sapporo Medical University of Medicine
Address
South 1 West 17, Chuo Ku, Sapporo
Tel
011-611-2111
mariya.tasuku@sapmed.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
| 2024 | Year | 12 | Month | 25 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064649
