UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038411 |
|---|---|
| Receipt number | R000043345 |
| Scientific Title | Ovarian Tissue Cryopreservation to improve Quality of Life for the young women with autoimmune disease or cancer. |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2022/11/03 16:32:31 |
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Basic information
Public title
Ovarian Tissue Cryopreservation to improve Quality of Life for the young women with autoimmune disease or cancer.
Acronym
Ovarian Tissue Cryopreservation to improve QOL for the young women with autoimmune disease or cancer.
Scientific Title
Ovarian Tissue Cryopreservation to improve Quality of Life for the young women with autoimmune disease or cancer.
Scientific Title:Acronym
Ovarian Tissue Cryopreservation to improve QOL for the young women with autoimmune disease or cancer.
Region
| Japan |
Condition
Condition
cancer or autoimmune disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the safe ovarian tissue cryopreservation for fertility preservation of the young women with cancer or autoimmune disease after their therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The influence for the main disease;cancer or autoimmune disease, and physical condition.
2.The assessment for the ovarian tissue resected by our clinical research.
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
(1)Cryopreservation of ovary: vitrification
(2)Treatment: addmittion for operation; 3-6days for laparoscopy, 6-10days for laparotomy. Oophorectomy by laparoscopy or laparotomy under general anesthesia. Cyropreservation of ovary with Ova Cryo Kit Type M(KITAZATO CORPORATION). Assessment for ovarian tisuue with H.E. staining.
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
| 7 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1.the case who will be ovarian insufficiency with treatment for cancer or autoimmune disease.
2.the case who hopes fertility preservation.
3.the case whose condition is pre or early stage of treatment.
4.the case whose condition is operable by judgment of attending physician.
5.Ageis the above of 7, less than 40
6.the case whose long term prognosis is expected by judgment of attending physician.
7.the case who understood the meaning, merit and demerit of ovarian tissue cryopreservation at our onco-fertility clinic.
Key exclusion criteria
1.the case judged inappropriate by the doctor in charge.
2..the case whose long term prognosis is not expected by judgment of attending physician.
3.the case whose condition is unoperable.
4.the case whose ovary has malignant tissue.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university hospital
Division name
Obstetrics and Gynecology department
Zip code
980-8574
Address
1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7254
masahito555@msn.com
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
TOHOKU University Hospital
Division name
Obstetrics and Gynecology department
Zip code
980-8574
Address
1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
TEL
0227177254
Homepage URL
masahito555@msn.com
Sponsor or person
Institute
Tohoku University Hospital
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
Tohoku University Hospital
Address
1-1, Seiryou-machi, Aoba-ku, Sendai, Miyagi
Tel
0227177254
naomit@med.tohoku.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
| 2019 | Year | 12 | Month | 10 | 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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043345
| 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 |
