Male fertility (male reproductive function)
Conditions
Interventions
None listed
Sponsors
Medical Corporation Heishinkai OPHAC Hospital
National Institute of Advanced Industrial Science and Technology (AIST)
University of Tsukuba, and University of Tsukuba Hospital
International University of Health and Welfare Nasu Medical Center, and Graduate School of International University of Health and Welfare
National Institute for Environmental Studies
Nagoya University
Tsukuba Gakuen Hospital
National Institute for Minamata Disease (NIMD)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Group 1: Healthy men aged 18 to <25 years, never-smokers, BMI 18.5 to <25 kg/m2, ejaculation frequency >=10/month on average during the previous 6 months, without the specified reproductive/systemic disease or hormone-medication history, and able to comply with 48 to <144 hours of abstinence before semen collection. Group 2: Healthy men aged 18 to <42 years, without the specified reproductive/systemic disease or hormone-medication history, ejaculation frequency >=1/month on average during the previous 6 months, and able to comply with 48 to <144 hours of abstinence, two visits, an 8:00-11:00 AM study visit, dinner by about 9:00 PM the previous day, and no breakfast. Group 3: Men aged 18 to <42 years who are the spouse or partner of a pregnant woman and self-report being the biological father. Pregnancy must have been established within 12 months after stopping contraception or starting regular unprotected intercourse, without IUI, IVF, or ICSI (timed intercourse guidance, ovulation induction, and syringe insemination are permitted). Fetal cardiac activity must have been confirmed and the pregnancy must be ongoing at each semen collection. Participants must comply with 48 to <144 hours of abstinence, one information visit and three study visits at 8:00-11:00 AM, dinner by about 9:00 PM the previous day, no breakfast, and reporting of ejaculation history for the specified periods.
Exclusion criteria
Exclusion criteria: Individuals who may suffer unjust disadvantage if they do not participate, those with cognitive impairment (e.g., dementia) that makes understanding difficult, those with psychiatric disorders (e.g., depression, schizophrenia, bipolar disorder) that makes understanding difficult, those with poor physical condition including temporary cold-like symptoms (e.g., chills, fatigue), or those otherwise deemed inappropriate by the principal investigator/study physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm microscopy image data; Sperm DNA fragmentation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Semem: Semen volume, sperm concentration, total motility, progressive motility, immotility, normal morphology rate, sperm deformity rate, pH, round cell concentration, static oxidative reduction potential, trace and major elements, Inhibin B, INSL3, Microbiota Urine: Phthalate esters, parabens, pesticides, soy isoflavones, trace/major elements, chemical speciation elements, creatinine, specific gravity, blood urea nitrogen. Blood: FSH, LH, testosterone, free testosterone, DHEA-S, SHBG, DHT, estradiol, prolactin, anti-mullerian hormone, Inhibin B, INSL3, serum albumin, fasting glucose, serum insulin, organofluorine compounds, trace elements, Steroid hormones, steroid hormone conjugates, and Girard-derivatized steroid hormones, Lipid analysis. Feces: short-chain fatty acids and gut microbiota. Physical measurements: grip strength, back strength, body composition, body circumferences, Hip adductor and abductor muscle strength, Pelvic floor muscles, and questionnaire/interview data. | — |
Countries
Japan
Contacts
Public ContactMichio Yagi
Medical Corporation Heishinkai OPHAC Hospital None
Outcome results
None listed