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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021746
Receipt No. R000025062
Scientific Title Ovarian tissue cryopreservation for fertility-preservation of Children and young adults with cancer
Date of disclosure of the study information 2016/05/01
Last modified on 2019/05/28

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Basic information
Public title Ovarian tissue cryopreservation for fertility-preservation of Children and young adults with cancer
Acronym Ovarian tissue cryopreservation for fertility-preservation
Scientific Title Ovarian tissue cryopreservation for fertility-preservation of Children and young adults with cancer
Scientific Title:Acronym Ovarian tissue cryopreservation for fertility-preservation
Region
Japan

Condition
Condition Cancer patient
Classification by specialty
Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Obsterics and gynecology Pediatrics Orthopedics
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verification of the effectiveness and safety in ovarian tissue cryopreservation as a clinical study for a fertility-preservation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pregnancy rate, birth rate and complications by the operation
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 Treatment
Type of intervention
Other
Interventions/Control_1 All the members receive the same medical intervention
Period (routinely the operation of oopholectomy)
Medicational quantity (different among individuals)
The number of times (1time)
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
42 years-old >=
Gender Female
Key inclusion criteria Survival is anticipated for a long term
Younger than 42 years
Key exclusion criteria An agreement is not obtained
Patient (including age 43 years old or more) who are judged to be inappropriate of this study
The patient whom the start of therapy delays for this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Mandai
Organization Graduate school of medicine, Kyoto University
Division name Department of obstetrics and gynecology
Zip code 606-8507
Address Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL 075-751-3111
Email mandai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Akihito
Middle name
Last name Horie
Organization Graduate school of medicine, Kyoto University
Division name Department of obstetrics and gynecology
Zip code 606-8507
Address Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL 075-751-3269
Homepage URL
Email a_horie@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate school of medicine, Kyoto University
Department of obstetrics and gynecology
Institute
Department

Funding Source
Organization Graduate school of medicine, Kyoto University
Department of obstetrics and gynecology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kyoto University Hospital / department of Ob & Gy
Address Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
Tel 075-751-3111
Email kuobgyn@kuhp.kyoto-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
2016 Year 05 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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 01 Day
Date of IRB
2016 Year 09 Month 23 Day
Anticipated trial start date
2016 Year 09 Month 23 Day
Last follow-up date
2021 Year 09 Month 22 Day
Date of closure to data entry
2021 Year 09 Month 22 Day
Date trial data considered complete
2021 Year 09 Month 22 Day
Date analysis concluded
2021 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 01 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025062

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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