UMIN-CTR Clinical Trial

Basic information
Public title	A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Acronym	A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Scientific Title	A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Scientific Title:Acronym	A Randomized Crossover Trial of the Efficacy of Device Masturbation in Patients with Difficult Ejaculation
Region	Japan

Condition
Condition	Infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To conduct a practical study of the efficacy of manual and device-based masturbation on ejaculation in male patients who experience ejaculation difficulties during masturbation during fertility treatment using a randomized crossover study design.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction in the difficulty of masturbation as measured by the visual analog scale (VAS).
Key secondary outcomes	Maximum penile hardness, semen testing parameters, and safety

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Each patient's normal method of masturbation.
Interventions/Control_2	A method of masturbation in which the penis is stimulated with a masturbation device while a medical condom is attached to the erect penis and ejaculated into the medical condom.
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	Self-identification of ejaculation difficulties during masturbation (confirmed by medical history) with little or no history of erectile dysfunction medication or device masturbation.
Key exclusion criteria	(1) regular use of erectile dysfunction medication, (2) unwillingness to masturbate with a device, (3) history of diabetes, (4) history of malignant disease, (5) history of depression, (6) other factors that may interfere with participation in the clinical trial
Target sample size	90

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	5300011
Address	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL	+81663778824
Email	komiya520@ivfjapan.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	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
TEL	+81663778824
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	Medical Corporation Sankeikai IRB
Address	Grand Front Osaka Tower B15F, 3-1 Ohfuka-cho, Kita-ku, Osaka City
Tel	+81663778824
Email	komiya0703@gmail.com

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	HORACグランフロント大阪クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 09 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	12
Results	No significant differences in semen findings were found.
Results date posted	2022 Year 10 Month 12 Day
Results Delayed	Delay expected
Results Delay Reason	The paper is currently being submitted for publication.
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	Completed
Date of protocol fixation	2021 Year 03 Month 01 Day
Date of IRB	2017 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 05 Month 31 Day
Date trial data considered complete	2022 Year 07 Month 31 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 04 Month 09 Day
Last modified on	2022 Year 10 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050094