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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047677
Receipt No. 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 2022/05/08

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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
Obsterics 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
Email 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
Email jsugawara@med.tohoku.ac.jp

Sponsor
Institute Tohoku Medical Megabank Organization
Institute
Department

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
Email 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
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 Preinitiation
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
2022 Year 05 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051864

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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