Clinical Trial: Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests (Japan)

Tokyo, Dec. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059935) titled 'Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests' on Dec. 1.

Study Type: Observational

Primary Sponsor: Institute - University of Tsukuba

Condition: Condition - Male infertility Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 615

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068549

Disclaimer: Curated by HT Syndication.