UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029918 |
|---|---|
| Receipt number | R000034182 |
| Scientific Title | Preservation of fertility by cryopreservation of ovarian tissue and autologous transplantation of ovarian tissue in women under18 age diagnosed with malignant tumors |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2020/05/11 11:30:31 |
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Basic information
Public title
Preservation of fertility by cryopreservation of ovarian tissue and autologous transplantation of ovarian tissue in women under18 age diagnosed with malignant tumors
Acronym
Preservation of fertility by cryopreservation of ovarian tissue in women under 18 age
Scientific Title
Preservation of fertility by cryopreservation of ovarian tissue and autologous transplantation of ovarian tissue in women under18 age diagnosed with malignant tumors
Scientific Title:Acronym
Preservation of fertility by cryopreservation of ovarian tissue in women under 18 age
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 | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Preserve of fertility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pregnancy rate by autologous transplantation 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
| 3 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Female
Key inclusion criteria
Patients must:
1 meet the disease and age criteria
2 has consented the study in a written form
3 be under the age 45 and obtain another written consent by the physician treating her primary disease at the time of autotransplantation
4 make an annual visit to the clinic during the period requiring cryopreservation
Key exclusion criteria
Cryopreservation and autotransplantation
1 Patients with a high probability of metastasis of the original disease to the ovary
2 Patients with obvious infections
3 Patients with severe uncontrollable complications
4 Patients whose doctor judges that this study is inappropriate for participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Ikeda |
Organization
Mie University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
t-ikeda@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Maezawa |
Organization
Mie University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
tada-m@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie 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
Medical Research Ethics Committee, Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie, Japan
Tel
059-232-1111
s-kenkyu@mo.medic.mie-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
| 2017 | Year | 11 | Month | 14 | 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
6
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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034182
