UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021499 |
|---|---|
| Receipt number | R000024795 |
| Scientific Title | Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2018/03/19 13:36:08 |
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Basic information
Public title
Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Acronym
Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Scientific Title
Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Scientific Title:Acronym
Research for cryopreservation and reuse of ovarian tissue and oocytes using ovaries obtained from gender identity disorder patients
Region
| Japan | North America |
Condition
Condition
gender identity disorder
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of cryopreservation and reuse of ovarian tissue and oocytes and its application to infertility and fertility preservation of cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
viability of transplanted ovarian tissue
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Gender identity disorder patients who undergo sex reassignment surgery (hysterectomy and oophorectomy) and provide informed consent to the present research
Key exclusion criteria
Gender identity disorder patients who do not provide informed consent to the research or for whom sex reassignment surgery is contraindicated
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Takai |
Organization
Saitama Medical Center/ Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3681
yastakai@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takai |
Organization
Saitama Medical Center/ Saitama Medical University
Division name
Department of Obstetrics and Gynecology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, Japan
TEL
049-228-3681
Homepage URL
yastakai@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
| 2016 | Year | 03 | Month | 16 | 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
| 2011 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | 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
Cohort study for GID patients who visit our clinic between May 1, 2011 and March 31, 2016 and are eligible for our study protocol.
Ovarian tissue and oocytes obtained by sex reassignment surgery are cryopreserved. Cryopreserved ovarian tissue are thawed and transplanted to immunodeficient mice, and survival rate of oocytes is evaluated.
Oogonial stem cells are extracted from cryopreserved ovarian tissue, and utilized for oocyte survival in the transplanted tissue.
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | 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=R000024795
| 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 |
