UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056050 |
|---|---|
| Receipt number | R000063792 |
| Scientific Title | The Preconception Research and Education Study for Men in Sapporo (PRES-MS): a randomized controlled trial |
| Date of disclosure of the study information | 2024/11/07 |
| Last modified on | 2024/12/05 13:11:05 |
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Basic information
Public title
The Preconception Research and Education Study for Men in Sapporo (PRES-MS): a randomized controlled trial
Acronym
PRES-MS
Scientific Title
The Preconception Research and Education Study for Men in Sapporo (PRES-MS): a randomized controlled trial
Scientific Title:Acronym
The Preconception Research and Education Study for Men in Sapporo (PRES-MS): 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 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
Sperm DNA fragmentation index one year after baseline
Key secondary outcomes
Semen quality (count, concentration, and motility), health status, health behaviors, gut microbiota and bacterial metabolites, seminal microbiota, salivary testosterone and cortisol levels, and oral microbiota one year after baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Health education videos (3 times in total, every 4 months) and email interventions (3 times in total, every 4 months) regarding male fertility and overall lifestyle
Interventions/Control_2
Health education videos (3 times in total, every 4 months) and email interventions (3 times in total, every 4 months) regarding male fertility and physical activity
Interventions/Control_3
Health education videos (3 times in total, every 4 months) and email interventions (3 times in total, every 4 months) regarding male fertility and diet
Interventions/Control_4
Control
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male
Key inclusion criteria
Men aged between 18 and 39 years old
Key exclusion criteria
None
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Public Health
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
+81-11-706-5068
maedae@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Public Health
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan
TEL
+81-11-706-5068
Homepage URL
maedae@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido 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
Dokkyo Medical University Saitama Medidcal Center, National Institute for Environmental Studies
Name of secondary funder(s)
Hokkaido University COI-NEXT "Co-Creation Base for Life Design of Mind and Body"
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
+81-11-706-7636
crjimu@huhp.hokudai.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
| 2024 | Year | 11 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 18 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063792
