UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062763 |
|---|---|
| Receipt number | R000071858 |
| Scientific Title | Effects of Sauna Bathing and Hot Baths on Semen Parameters: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/09/01 11:28:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Sauna Bathing and Hot Baths on Semen Parameters: A Randomized Controlled Trial
Acronym
Sauna Bathing and Hot Baths in Relation to Semen Parameters
Scientific Title
Effects of Sauna Bathing and Hot Baths on Semen Parameters: A Randomized Controlled Trial
Scientific Title:Acronym
Sauna Bathing and Hot Baths in Relation to Semen Parameters
Region
| Japan |
Condition
Condition
Male Reproductive Health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, healthy men aged 18-44 years who have children and are interested in sauna bathing or hot bathing will be randomly assigned to one of three groups: a sauna bathing group, a hot bathing group, or a control group. Changes in semen parameters will be assessed by comparing the three groups and by evaluating changes from baseline to post-intervention.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in sperm concentration at 3 months after the intervention in Intervention Group 1
Key secondary outcomes
Values and changes from baseline at 3, 6, and 9 months after the intervention in Intervention Groups 1 and 2 for the following outcomes:
Semen parameters: sperm count, sperm concentration, sperm motility, sperm DNA fragmentation index, etc.
Health status: BMI and body composition
Gut microbiota, microbial metabolites, and seminal microbiota
Stress levels: SRS-18 score and salivary cortisol concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After adequate hydration, participants will complete three sets of sauna bathing, with each set consisting of 8-12 minutes in a sauna at 80-90C, followed by 2 minutes in a cold-water bath. This regimen will be performed twice a week for 3 months.
Interventions/Control_2
After adequate hydration, participants will take a hot bath at 42-43C for 5 minutes, 5 times per week for 3 months.
Interventions/Control_3
Participants in the control group will not undergo sauna bathing or hot bathing.
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
| 18 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Male
Key inclusion criteria
Participants must meet all of the following criteria:
1. Men aged 18-44 years at the time of informed consent.
2. Have at least one biological child.
3. Do not plan to have another child within the next year.
4. Have not engaged in the intervention activities (sauna bathing or hot bathing) for at least 6 months. Individuals who have used a sauna at least once per week or taken hot baths at temperatures above 42C at least three times per week within the past 6 months will be excluded.
5. Have no self-reported chronic diseases or regular medication use.
6. Have no findings requiring medical treatment in their most recent health checkup (conducted within the previous year).
7. Do not meet the criteria for Grade 2 or higher hypertension, defined as a systolic blood pressure of 160 mmHg or higher or a diastolic blood pressure of 110 mmHg or higher, based on blood pressure measurements taken at the Department of Public Health, Faculty of Medicine and Graduate School of Medicine, Hokkaido University.
8. Have provided written informed consent to participate in the study voluntarily after receiving sufficient information and explanation about the study in Japanese and demonstrating adequate understanding of the study.
Key exclusion criteria
None
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido University
Division name
Faculty of Medicine
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-5068
maedae@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Hokkaido University
Division name
Faculty of Medicine
Zip code
0608638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-5068
Homepage URL
https://www.publichealth-med-hokudai.jp/%E3%82%B5%E3%82%A6%E3%83%8A%E7%A0%94%E7%A9%B6
maedae@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
011-706-7636
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
| 2026 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071858
