UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016899 |
|---|---|
| Receipt number | R000019560 |
| Scientific Title | Ovarian tissue cryopreservation and auto-transplantation for patients raising concern about ovarian insufficiency |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/03/19 19:19:32 |
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Basic information
Public title
Ovarian tissue cryopreservation and auto-transplantation for patients raising concern about ovarian insufficiency
Acronym
Ovarian tissue cryopreservation for fertility preservation
Scientific Title
Ovarian tissue cryopreservation and auto-transplantation for patients raising concern about ovarian insufficiency
Scientific Title:Acronym
Ovarian tissue cryopreservation for fertility preservation
Region
| Japan |
Condition
Condition
Breast cancer, Non-Hodgkin's lymphoma, sarcoma, Aplastic anemia, Systemic lupus erythematosus, arthritis and other diseases necessitate alkylating agents or radiation therapy.
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
fertility preservation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
follicle growth rate by auto-transplantation of thawed ovarian tissue
Key secondary outcomes
pregnancy rate by auto-transplantation of thawed ovarian tissue
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
ovarian tissue cryopreservation
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
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients must:
1.meet the disease and age criteria
2.have consented the study in a written form and obtain another written consent by the physician treating her primary disease at the time of auto-transplantation
3.agree to be anytime contacted from hospital stuff
Key exclusion criteria
A patient is excluded from cryopreservation if:
1.the physician treating her primary disease has decided that this study is not suitable for her
2.this study have concern about delaying the treatment for her primary disease
A patient is excluded from auto-transplantation if:
1.she has reached over reproductive age
2.she has serious complication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aikou Okamoto |
Organization
The Jikei University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-25-8 Nishi-shinbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
aikou7000@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Haino |
Organization
The Jikei University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
3-25-8 Nishi-shinbashi Minato-ku Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
dmem45ml@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
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
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
| 2015 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | 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
| 2015 | Year | 03 | Month | 24 | Day |
Last modified on
| 2015 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
