UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009379 |
|---|---|
| Receipt number | R000011023 |
| Scientific Title | Salvage gonadotropin therapy for men who could not retrieve sperms by microdissection testicular sperm extraction |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2016/05/22 08:44:48 |
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Basic information
Public title
Salvage gonadotropin therapy for men who could not retrieve sperms by microdissection testicular sperm extraction
Acronym
Hormonal therapy for non-obstructive azoospermia
Scientific Title
Salvage gonadotropin therapy for men who could not retrieve sperms by microdissection testicular sperm extraction
Scientific Title:Acronym
Hormonal therapy for non-obstructive azoospermia
Region
| Japan |
Condition
Condition
non-obstructive azoospermia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The porpose of this study is to validate the efficacy of hCG/FSH therapy for men with non-obstructive azoospermia who have failed to retreive sperms by micro-TESE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sperm retreival rate
Key secondary outcomes
Histological improvement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hormonal therapy using hCG and FSH
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
Male
Key inclusion criteria
men who could have any sperms by micro-TESE
Key exclusion criteria
Men with mutation in AZFa or AZFb
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Shiraishi |
Organization
Yamaguchi University School of Medicine
Division name
Department of Urology
Zip code
Address
111 Minami-Kogushi, Ube
TEL
0836-22-2275
shirak@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Shiraishi |
Organization
Department of Urology
Division name
111 Minami-Kogushi, Ube
Zip code
Address
111 Minami-Kogushi, Ube
TEL
0836-22-2275
Homepage URL
shirak@yamaguchi-u.ac.jp
Sponsor or person
Institute
Departmnt of Urology, Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
International University of Health and welfare
Ishikawa Hospital
UBE Industries Central Hospital
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
国際医療福祉大学（栃木県）
石川病院（兵庫県）
宇部興産中央病院(山口県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 21 | Day |
Last modified on
| 2016 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011023
| 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 |
