UMIN-CTR Clinical Trial

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
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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
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Research case data
Registered date	File name

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