UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	komiya0703@gmail.com

Sponsor
Institute	HORAC Grand Front Osaka Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043438