UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032032 |
|---|---|
| Receipt number | R000036295 |
| Scientific Title | Fertility Preservation by means of ovarian tissue cryopreservation for Adolescent and Young Adult Women with cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/03/19 17:05:28 |
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Basic information
Public title
Fertility Preservation by means of ovarian tissue cryopreservation for Adolescent and Young Adult Women with cancer
Acronym
Fertility Preservation by means of ovarian tissue cryopreservation for Adolescent and Young Adult Women with cancer
Scientific Title
Fertility Preservation by means of ovarian tissue cryopreservation for Adolescent and Young Adult Women with cancer
Scientific Title:Acronym
Fertility Preservation by means of ovarian tissue cryopreservation for Adolescent and Young Adult Women with cancer
Region
| Japan |
Condition
Condition
AYA women with cancer patient including hematological malignancy, autoimmune disease
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness and safety in fertility preservation by means of ovarian tissue cryopreservation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation for a prospective advantage(fertility preservation) and disadvantage(complications by laparoscopic surgery)
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
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
All the members receive the same medical intervention by laparoscopic sugery
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
| Not applicable |
Gender
Female
Key inclusion criteria
Survival is anticipated for a long term
After the menarche, younger than 42 years
Key exclusion criteria
Informed Consent is not obtained
Patient who are judged to be inappropriate to this study by her doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shibahara Hiroaki |
Organization
Hyogo College of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Hyogo College of Medicine College Hospital, 1-1 Mukogawa-cho, Nishinomiya, HYOGO 653-8501, JAPAN
TEL
+81-798-45-6481
sibahara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Wakimoto |
Organization
Hyogo College of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Hyogo College of Medicine College Hospital, 1-1 Mukogawa-cho, Nishinomiya, HYOGO 653-8501, JAPAN
TEL
+81-798-45-6481
Homepage URL
yuuwakimoto@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine, Department of Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine College 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
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | 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
| 2018 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | 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=R000036295
