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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009379
Receipt No. 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

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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
Email 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
Email shirak@yamaguchi-u.ac.jp

Sponsor
Institute Departmnt of Urology, Yamaguchi University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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