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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038411
Receipt No. 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 2019/12/10

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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
Obsterics 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
Email 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
Email masahito555@msn.com

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
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
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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