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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043664
Receipt No. R000049862
Scientific Title The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021)
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/18

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Basic information
Public title The outcome of fertility preservation treatment in JAPAN (2021)
Acronym The outcome of fertility preservation treatment in JAPAN (2021)
Scientific Title The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021)
Scientific Title:Acronym The outcome of Embryo and oocyte and ovarian tissue in JAPAN (2021)
Region
Japan

Condition
Condition Breast cancer, hematological cancer, and so on
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verification of the efficacy of fertility preservation treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Live birth rate
Key secondary outcomes pregnancy rate, the numbers of extracted oocyte, and so on.

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
1 days-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria The patient who underwent embryo, oocyte, or ovarian tissue cryopreservation as fertility preservation treatment.
Key exclusion criteria The patients who decline to contribute the present study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name NAO
Middle name
Last name SUZUKI
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL 044-977-8111
Email nao@marianna-u.ac.jp

Public contact
Name of contact person
1st name SEIDO
Middle name
Last name TAKAE
Organization St. Marianna University School of Medicine
Division name Obstetrics and Gynecology
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL 044-977-8111
Homepage URL
Email s2takae@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Health and Welfare Ministry
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board of St. Marianna University
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.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
2021 Year 04 Month 01 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 03 Month 17 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Questionnaire sheet will be sent to the institution and hospital which are registered Japan society of Obstetrics and Gynecology, for investigating the numbers of case, and outcome of treatment. Also, the outcome which are already investigated will be include to present study (already we got the permission).

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049862

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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