UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047677 |
|---|---|
| Receipt number | R000051864 |
| Scientific Title | Exploratory study of genome alteration and rearrangement associated with ART (Assisted Reproductive Technology) using birth and three-generation cohort study (TMM BirThree Cohort Study). |
| Date of disclosure of the study information | 2022/05/10 |
| Last modified on | 2024/01/04 16:08:15 |
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Basic information
Public title
Exploratory study of genome alteration and rearrangement associated with ART (Assisted Reproductive Technology) using birth and three-generation cohort study (TMM BirThree Cohort Study).
Acronym
Exploratory study of genome alteration and rearrangement associated with ART (Assisted Reproductive Technology) using birth and three-generation cohort study (TMM BirThree Cohort Study).
Scientific Title
Exploratory study of genome alteration and rearrangement associated with ART (Assisted Reproductive Technology) using birth and three-generation cohort study (TMM BirThree Cohort Study).
Scientific Title:Acronym
Exploratory study of genome alteration and rearrangement associated with ART (Assisted Reproductive Technology) using birth and three-generation cohort study (TMM BirThree Cohort Study).
Region
| Japan |
Condition
Condition
Birth Children and their family that are classified with conception method, IVF, ICSI and natural conception.
Classification by specialty
| Obstetrics and Gynecology | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
ART (Assisted Reproductive Technology) is widely used for infertile couple and is indispensable for maintain birth rate. To date, there is still an unsolved fundamental thorny issue which safety concern of ART for next generation. This study explores the genome alteration and rearrangement associated with ART using birth and three-generation cohort study (TMM BirThree Cohort Study). Our main goal of this study is to provide accurate safety information to children born via ART, their family and infertile couple seeking future reproductive option.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of genome alteration and rearrangement, and hereditary, and an association of conception methods, IVF, ICSI and natural conception.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants, birth children and their family, are selected via questionaries of the birth and three-generation cohort study (TMM BirThree Cohort Study) based on conception methods, IVF, ICSI and natural conception. Eligibility is then evaluated via availability of their genome information in the genome reference panels, 54K Japonica Array NEO and jMorp 8.3K JPN, created by Tohoku Medical Megabank project.
Key exclusion criteria
Not applicable
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Sugawara |
Organization
Tohoku Medical Megabank Organization
Division name
Dept of Community Medical Support
Zip code
9808574
Address
2-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227236283
jsugawara@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Sugawara |
Organization
Tohoku Medical Megabank Organization
Division name
Dept of Community Medical Support
Zip code
9808574
Address
2-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227236283
Homepage URL
jsugawara@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Medical Megabank Organization
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
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
Tohoku Medical Megabank Organization
Address
2-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
Tel
0227236283
jsugawara@med.tohoku.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
| 2022 | Year | 05 | Month | 10 | 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
6
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
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051864
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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