UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013936 |
|---|---|
| Receipt number | 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 14:11:51 |
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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
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
tomonakamura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital Department of Obstetrics and Gynecology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
