UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000377 |
|---|---|
| Receipt number | 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 10:03:38 |
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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
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
Sponsor or person
Institute
The Japanese Urorogical Association
Forum of operative technique in male infertility
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000472
