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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013936
Receipt No. R000016238
Scientific Title Autotransplantation and culture of cryopreserved ovarian tissue in patients with cancer or immunologic diseases to preserve fertility.
Date of disclosure of the study information 2014/08/01
Last modified on 2016/05/18

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Basic information
Public title Autotransplantation and culture of cryopreserved ovarian tissue in patients with cancer or immunologic diseases to preserve fertility.
Acronym Autotransplantation and culture of cryopreserved ovarian tissue
Scientific Title Autotransplantation and culture of cryopreserved ovarian tissue in patients with cancer or immunologic diseases to preserve fertility.
Scientific Title:Acronym Autotransplantation and culture of cryopreserved ovarian tissue
Region
Japan

Condition
Condition Breast cancer, leukemia, malignant lymphoma (Hodgkin's and Non-Hodgkin's), other hematopoietic diseases (hypoplastic anemia, myelodysplastic syndrome, myeloma), sarcoma, systemic lupus erythematosus, rheumatic arthritis and other diseases requiring alkylating agents or radiation therapies.
Classification by specialty
Medicine in general Surgery in general
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 to preserve fertility
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fertility by autotransplantation of cryopreserved ovarian tissue
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
Maneuver
Interventions/Control_1 cryopreservation of ovarian tissue
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
18 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Patients must meet all of the following:
1 meets the disease and age criteria
2 has a signed informed and consent form
3 as for autotransplantation, must be equal to or under the age 50 and must have a signed consent by the physician treating the primary disease
4 must make an annual visit to the clinic during the period requiring cryopreservation
Key exclusion criteria Exclusion criteria for cryopreservation:
1 has a serious complication
2 inability to judge or unable to confirm his/her wishes
3 if this study will delay the treatment for the primary disease
4 other situations where the physician treating the primary disease decides the patient unfit for this study

Exclusion criteria for autotransplantation:
1 has a serious complication
2 inability to judge or unable to confirm his/her wishes
3 if autotransplantation is a risk for the patient
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Iwase
Organization Nagoya University Hospital
Division name Perinatal Medical Center
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2261
Email akiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Nakamura
Organization Nagoya University Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2261
Homepage URL
Email tomonakamura@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital Department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Nagoya University Hospital
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
Address
Tel
Email

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
2014 Year 08 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 Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2016 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016238

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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