Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests

Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests - Exploratory multi-institutional collaborative study to establish chemical analysis methods for environmental pollution biomonitoring using leftover specimens from male infertility tests

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059935

Enrollment

650

Registered

2025-12-01

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

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 650 participants are planned in total: around 300 in category (a), 300 in category (b) and up to 50 volunteers in category (c).

Exclusion criteria

Exclusion criteria: 1) Individuals who express refusal to participate in the study. 2) Individuals deemed inappropriate by the investigators.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Japan

Contacts

Public ContactKosuke Kojo

University of Tsukuba Hospital Department of Urology

kojou-tuk@md.tsukuba.ac.jp+81-29-853-3223

Outcome results