UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038107 |
|---|---|
| Receipt number | R000043438 |
| Scientific Title | Efficacy of a sperm sampling device to improve semen collection |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2021/10/09 09:30:12 |
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Basic information
Public title
Efficacy of a sperm sampling device to improve semen collection
Acronym
Efficacy of a sperm sampling device to improve semen collection
Scientific Title
Efficacy of a sperm sampling device to improve semen collection
Scientific Title:Acronym
Efficacy of a sperm sampling device to improve semen collection
Region
| Japan |
Condition
Condition
sterility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the device during infertility treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ejaculation time
Key secondary outcomes
*degree of sexual arousal and pleasure
*convenience and discomfort level
*semen analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
masturbation with semen cllection device
Interventions/Control_2
masterbation with their own hand
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
male staff of our clinic
Key exclusion criteria
Persons who did not obtain consent to participate
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Shinnosuke |
| Middle name | |
| Last name | KOMIYA |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
15th Floor Tower B Grand Front Osaka 3-1 Ofuka, Kita, Osaka, JAPAN
TEL
0663778824
komiya0703@gmail.com
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | KOMIYA |
Organization
HORAC Grand Front Osaka Clinic
Division name
Gynecology
Zip code
530-0011
Address
15th Floor Tower B Grand Front Osaka 3-1 Ofuka, Kita, Osaka, JAPAN
TEL
0663778824
Homepage URL
komiya0703@gmail.com
Sponsor or person
Institute
HORAC Grand Front Osaka Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
HORAC Grand Front Osaka Clinic
Address
15th Floor Tower B Grand Front Osaka 3-1 Ofuka, Kita, Osaka, JAPAN
Tel
0663778824
komiya0703@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2017-30
Org. issuing International ID_1
Sunkaky Medical Corporation IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
7
Results
There were no significant differences in ejaculation time, sexual arousal, or pleasure scale.
The device reduced the ease of masterbation.
For semen testing, sperm motility was significantly worse with the use of the device (P = 0.028). There were no significant differences in other parameters.
Results date posted
| 2019 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male staff of our clinic
Participant flow
After obtaining written consent to participate in the study, the participants alternated between normal masturbation and device masturbation, and completed a post-masturbation questionnaire.
Adverse events
none
Outcome measures
ejaculation time
sexual arousal
sexual comfort sensitivity
ease of masturbation
degree of discomfort
sperm finding
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 21 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 17 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043438
| 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 |
