UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059935 |
|---|---|
| Receipt number | R000068549 |
| Scientific Title | Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/12/01 20:09:38 |
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Basic information
Public title
Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests
Acronym
Environmental Pollution Biomonitoring using Residual Male Infertility Samples
Scientific Title
Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests
Scientific Title:Acronym
Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests
Region
| Japan |
Condition
Condition
Male infertility
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform comprehensive chemical analyses of leftover specimens (semen, seminal plasma, blood and urine) from male infertility examinations and explore what environmental contaminants are present and at what levels.
Basic objectives2
Others
Basic objectives -Others
Establishment of chemical analysis methods useful for biomonitoring environmental pollution.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
At the time of specimen collection, identify environmental chemicals present in semen, seminal plasma, blood and urine samples from male infertility examinations using analytical techniques (ICP-MS, LC-ICP-MS, GC-MS/MS, NMR, etc.) of collaborative institutions and assess whether quantitative measurement is feasible.
Key secondary outcomes
1) Descriptive statistics (mean, standard deviation, median and interquartile range) of quantified chemicals in the study population; for specimens obtained by split ejaculation, compare each fraction. 2) Explore correlations or group comparisons between quantified chemical levels and clinical findings of male infertility (sperm concentration, motility) or exposure-related information (e.g., smoking history).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Aged 18 years or older at the time of specimen collection. 2) Meets any of the following: (a) Patients who underwent male infertility examinations at the University of Tsukuba between 1 Apr 2018 and 31 Mar 2026 and whose samples (blood, urine, semen) are stored with broad consent - blood/urine in TMER and semen in the biobank; (b) Participants in the previous study "Development of methods for measuring trace elements in seminal plasma and serum of male infertility patients" who have not expressed refusal for secondary use; (c) Volunteers who have participated in other studies and have undergone semen analysis at least once within one year with no abnormal findings; recruitment period is from study approval until 31 Mar 2028. Approximately 615 participants are planned in total: around 300 in category (a), 300 in category (b) and up to 15 volunteers in category (c).
Key exclusion criteria
1) Individuals who express refusal to participate in the study. 2) Individuals deemed inappropriate by the investigators.
Target sample size
615
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Nishiyama |
Organization
University of Tsukuba
Division name
Department of Urology, Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
+81-29-853-3223
urology@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kojo |
Organization
University of Tsukuba Hospital
Division name
Department of Urology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
+81-29-853-3223
Homepage URL
kojou-tuk@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Renatech Co., Ltd., National Institute of Advanced Industrial Science and Technology (AIST), National Agriculture and Food Research Organization (NARO), National Institute for Environmental Studies (NIES)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
Tel
+81-29-853-3223
kojou-tuk@md.tsukuba.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
| 2025 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | 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
This study is a multi-institutional collaborative observational study primarily using secondary data from existing human biological samples (remnant specimens from male infertility testing). Although it includes sample collection from newly recruited volunteers, this is categorized as a study involving minimal invasiveness.
Management information
Registered date
| 2025 | Year | 12 | Month | 01 | Day |
Last modified on
| 2025 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068549
