UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060395 |
|---|---|
| Receipt number | R000069079 |
| Scientific Title | Research and development of male fertility assessment technology using AI-based sperm image analysis |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/18 10:49:35 |
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Basic information
Public title
Request for participation in the Sperm Function Measurement Technology Development Project
Acronym
N-SEED
Scientific Title
Research and development of male fertility assessment technology using AI-based sperm image analysis
Scientific Title:Acronym
Research and development of male fertility assessment technology using AI-based sperm image analysis
Region
| Japan |
Condition
Condition
Male fertility (male reproductive function)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study develop a male fertility assessment technology that links microscopic sperm image data with latent factors related to male fertility. As a preliminary step, this study prospectively collects biospecimens (urine, blood, and semen) and related data (semen examination results, physical measurements, and questionnaire/interview data) from healthy adult men, and statistically evaluates the associations between sperm image data and sperm functional assessment measures.
Basic objectives2
Others
Basic objectives -Others
Prospective data/biospecimen collection and association analyses to develop an AI-based male fertility assessment technology
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sperm microscopy image data;Sperm DNA fragmentation rate
Key secondary outcomes
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.
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.
Physical measurements: grip strength, back strength, body composition, body circumferences, and questionnaire/interview data.
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
| 42 | years-old | > |
Gender
Male
Key inclusion criteria
Group 1: Healthy men aged 18 to 25 years, non-smokers, BMI 18.5 to 25, over 10 ejaculations per month on average during the past 6 months, no history of congenital anomalies/diseases/trauma of male reproductive organs, no history/treatment of varicocele, no history/treatment of malignant tumors, endocrine disorders, or autoimmune diseases, no history of hormone medication, able to comply with an abstinence period of 48 to 144 hours before semen collection.
Group 2: Healthy men aged 18 to 42 years, no history of congenital anomalies/diseases/trauma of male reproductive organs, no history/treatment of varicocele, no history/treatment of malignant tumors, endocrine disorders, or autoimmune diseases, no history of hormone medication, over 1 ejaculation per month on average during the past 6 months, able to comply with an abstinence period of 48 to 144 hours, able to visit the study site between 8:00 to 11:00 on the study day and attend two visits, dinner by 21:00 on the day before and no breakfast on the study day.
Key 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.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Yagi |
Organization
Medical Corporation Heishinkai OPHAC Hospital
Division name
None
Zip code
532-0003
Address
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
TEL
06-6395-9000
michio.yagi@heishinkai.com
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Yagi |
Organization
Medical Corporation Heishinkai OPHAC Hospital
Division name
None
Zip code
532-0003
Address
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
TEL
06-6395-9000
Homepage URL
michio.yagi@heishinkai.com
Sponsor or person
Institute
Medical Corporation Heishinkai OPHAC Hospital
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology (AIST); University of Tsukuba, and University of Tsukuba Hospital; International University of Health and Welfare Hospital, and Graduate School of International University of Health and Welfare; National Institute for Environmental Studies; Nagoya University; Tsukuba Gakuen Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Heishinkai OPHAC Hospital ERC
Address
4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6395-9000
ophach_irb@heishinkai.com
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
医療法人 平心会 大阪治験病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069079
