UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026226 |
|---|---|
| Receipt number | R000030070 |
| Scientific Title | Establishment of external culture of testicular tissue |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/02/20 16:24:09 |
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Basic information
Public title
Establishment of external culture of testicular tissue
Acronym
Establishment of external culture of testicular tissue
Scientific Title
Establishment of external culture of testicular tissue
Scientific Title:Acronym
Establishment of external culture of testicular tissue
Region
| Japan |
Condition
Condition
Azoospermia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of new sperm acquisition method for patients who can not obtain sperm by testicular sperm collection method and have to abandon infertility therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To elucidate spermatogenesis induction andits molecular mechanism.
Key secondary outcomes
Functional analysis of sperm acquired and verification of normality
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1)Extra testicular tissue is collected from a patient who underwent the testicular sperm collection method for azoospermia.
2)Carry out boundary culture of gas phase liquid layer.
3)The presence or absence of spermatogenesis is examined by histological, molecular biological analysis.
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
| Not applicable |
Gender
Male
Key inclusion criteria
Azoospermia
Key exclusion criteria
Patient who the doctor in charge judged inappropriate as the subject of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhito Yoshioka |
Organization
St Marianna university school of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
2-16-1 Sugao Miyamae Kawasaki Kanagawa
TEL
0449778111
n3yoshioka@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhito Yoshioka |
Organization
St Marianna university school of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
2-16-1 Sugao Miyamae Kawasaki Kanagawa
TEL
0449778111
Homepage URL
n3yoshioka@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna university school of Medicine
Institute
Department
Personal name
Funding Source
Organization
St Marianna university school of Medicine
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
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
聖マリアンナ医科大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030070
