UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040576 |
|---|---|
| Receipt number | R000046311 |
| Scientific Title | The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients. |
| Date of disclosure of the study information | 2020/05/30 |
| Last modified on | 2020/08/18 08:31:46 |
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Basic information
Public title
The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Acronym
The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Scientific Title
The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Scientific Title:Acronym
The verification of safety and efficacy of ovarian tissue and oocyte cryopreservation for child patients.
Region
| Japan |
Condition
Condition
Leukemia, Lymphoma, rhabdomyosarcoma, Immuno deficiency, CAEBV, hematological disease, auto immune disease, collagen disease
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Clinical immunology |
| Infectious disease | Obstetrics and Gynecology | Pediatrics |
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the safety and efficacy of ovarian tissue and oocyte cryopreservation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety of surgery(operation time, blood loss, complication),the numbers of ovarian cortex, the numbers of retrieved oocyte
Key secondary outcomes
The existance of minimal residual disease
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | > |
Gender
Female
Key inclusion criteria
The consalt and permission from doctor for mrimary disease, long term survive is expected, the high risk of ovarian dysfunction due to therapy for primary disease, operable condition
Key exclusion criteria
No consult and permission from primary doctor, long term survival is not expected, no gonadal risk, very poor general condition
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | NAO |
| Middle name | |
| Last name | SUZUKI |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | SEIDO |
| Middle name | |
| Last name | TAKAE |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
TEL
044-977-8111
Homepage URL
s2takae@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Dt. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2020 | Year | 05 | Month | 30 | 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 | 11 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2035 | Year | 11 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now we already started the clinical research under permission of IRB.It need to observation for long period focused on the patient's condition including reproductive health.
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046311
| 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 |
