Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062763) titled 'Effects of Sauna Bathing and Hot Baths on Semen Parameters: A Randomized Controlled Trial' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - Hokkaido University
Condition:
Condition - Male Reproductive Health
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 27
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 26 Day
Anticipated trial start date - 2026 Year 09 Month 03 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071858
Disclaimer: Curated by HT Syndication.
