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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000377
Receipt No. R000000472
Scientific Title Treatment of varicocele: randomized prospective study on surgery.
Date of disclosure of the study information 2006/04/01
Last modified on 2007/05/17

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Basic information
Public title Treatment of varicocele: randomized prospective study on surgery.
Acronym Treatment of varicocele on surgery.
Scientific Title Treatment of varicocele: randomized prospective study on surgery.
Scientific Title:Acronym Treatment of varicocele on surgery.
Region
Japan

Condition
Condition varicocele
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study on treatment of varicocele on surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of natural pregnancy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 operation
Interventions/Control_2 medication
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 -Duration of infertility is more than one year and the patients have varicocele with grade II and III.
-The Partners are 35 or younger old and diagnose as fertility.
-Concentration of seminal fluid is 5 million/mL or greater and less than 20 million/mL.
-Seminal volume is 2mL or greater.
-Serum FSH level is within twice of upper limit of normal range.
Key exclusion criteria -Patients who fathers one child.
-Patients who are thoght to be diagnosed as no indication about operations of varicocele.
-Couples who have plan to be treated artificial reproduction techniques.
-Patients who is unable to ejaculate.
-Patients who is suffering from hypogonadotropic hypogonadism and has a disorder of chromatin
-Patients who were already performed operation of varicocele or seminal tract.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio Namiki
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrated Cancer Therapy and Urology
Zip code
Address 13-1 Takara Kanazawa Ishikawa
TEL 076-265-2393
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Namiki
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Integrated Cancer Therapy and Urology
Zip code
Address 13-1 Takara Kanazawa Ishikawa
TEL 076-265-2393
Homepage URL
Email

Sponsor
Institute The Japanese Urorogical Association
Forum of operative technique in male infertility
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2006 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 Terminated
Date of protocol fixation
2005 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2007 Year 04 Month 01 Day
Date trial data considered complete
2007 Year 04 Month 01 Day
Date analysis concluded
2007 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 28 Day
Last modified on
2007 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000472

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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