UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045389 |
|---|---|
| Receipt number | R000051826 |
| Scientific Title | Effects of preconception health education on healthy young men: a randomized controlled trial |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2024/03/09 19:38:13 |
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Basic information
Public title
Effects of preconception health education on healthy young men: a randomized controlled trial
Acronym
A health education study to prevent male infertility
Scientific Title
Effects of preconception health education on healthy young men: a randomized controlled trial
Scientific Title:Acronym
Effects of preconception health education on healthy young men: a randomized controlled trial
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology | Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure the short-term and long-term effects of video intervention on male fertility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We measure the semen quality, health status, health behaviours, and blood and urinary chemicals as short-term outcomes. As long-term outcomes, we measure the incidence of marriage, pregnancy, childbirths, and the health status of their children.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A few-minute-health educational videos regarding male fertility provided every 4 month, three times in total.
Interventions/Control_2
General health information provided by email, every 4 month, three times in total.
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
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Men aged between 20 and 39 years old, hoping to have a child in the future.
Key exclusion criteria
None
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University Graduate School of Medicine
Division name
Department of Environmental Health Science and Public Health
Zip code
010-8543
Address
1-1-1 Hondo, Akita 010-8543, Japan
TEL
+81-18-884-6088
erimaeda@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University Graduate School of Medicine
Division name
Department of Environmental Health Science and Public Health
Zip code
010-8543
Address
1-1-1 Hondo, Akita 010-8543, Japan
TEL
+81-18-884-6088
Homepage URL
erimaeda@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Akita University
Address
1-1-1 Hondo, Akita 010-8543, Japan
Tel
+81-18-884-6029
soken@hos.akita-u.ac.jp
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
| 2021 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
382
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051826
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/09/08 | 1_計画書（JST創発）ver2.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
