UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044838 |
|---|---|
| Receipt number | R000051216 |
| Scientific Title | The investigation of safety and efficacy of oocyte cryopreservation for two cases of Turner's syndrome. |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2021/08/11 10:33:56 |
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Basic information
Public title
The investigation of safety and efficacy of oocyte cryopreservation for two cases of Turner's syndrome.
Acronym
The investigation of safety and efficacy of oocyte cryopreservation for two cases of Turner's syndrome.
Scientific Title
The investigation of safety and efficacy of oocyte cryopreservation for two cases of Turner's syndrome.
Scientific Title:Acronym
The investigation of safety and efficacy of oocyte cryopreservation for two cases of Turner's syndrome.
Region
| Japan |
Condition
Condition
Turner's syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of oocyte cryopreservation for Tuner's girl.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The numbers of retrieved oocyte
Key secondary outcomes
complication
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
| Not applicable |
Gender
Female
Key inclusion criteria
Turner syndrome has been demonstrated by chromosomal testing, there is hope for fertility preservation, and it is psychologically accepted.
Key exclusion criteria
If the patients not have the consent of primary doctor, if the patients do not have the consent of herself or her family, or if it is judged that the patients cannot tolerate this treatment both physically and mentally.
Target sample size
2
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
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
Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa
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
N/A
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa
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
| 2021 | Year | 07 | Month | 13 | 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
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After IRB permission, the clinical study has started on thin August.
Management information
Registered date
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051216
