UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053821 |
|---|---|
| Receipt number | R000058693 |
| Scientific Title | Dynamic Alterations in Male Reproductive functions with Oral Administration of a Multivitamin Supplement Case-Control Study |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/03/12 17:06:27 |
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Basic information
Public title
Dynamic Alterations in Male Reproductive functions with Oral Administration of a Multivitamin Supplement Case-Control Study
Acronym
Dynamic Alterations in Male Reproductive functions with Oral Administration of a Multivitamin Supplement Case-Control Study
Scientific Title
Dynamic Alterations in Male Reproductive functions with Oral Administration of a Multivitamin Supplement Case-Control Study
Scientific Title:Acronym
Dynamic Alterations in Male Reproductive functions with Oral Administration of a Multivitamin Supplement Case-Control Study
Region
| Japan |
Condition
Condition
Male infertility
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pre- and post-intervention comparison of reproductive parameters in male patients attending an outpatient infertility clinic with a multivitamin supplementation intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Semen and sperm quality
Key secondary outcomes
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
| 29 | years-old | <= |
Age-upper limit
| 41 | years-old | >= |
Gender
Male
Key inclusion criteria
Male patient presenting with a chief complaint of infertility
Key exclusion criteria
Highly obese (BMI: >30), severe oligozoospermia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Ogawa |
Organization
Sendai ART Clinic
Division name
Reproductive Medicine
Zip code
983-0864
Address
206-13 Nagakecho, Miyagino-ku, Sendai City, Miyagi
TEL
022-791-8851
cfy00450@gmail.com
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Ogawa |
Organization
Sendai ART Clinic
Division name
Reproductive Medicine
Zip code
983-0864
Address
206-13 Nagakecho, Miyagino-ku, Sendai City, Miyagi
TEL
022-791-8851
Homepage URL
cfy00450@gmail.com
Sponsor or person
Institute
Sendai ART Clinic
Institute
Department
Personal name
Funding Source
Organization
Sendai ART Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical Univerisity
Address
1 Hikarigaoka, Fukushima city, Fukushima
Tel
024-547-1385
kuniakiota@gmail.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2076-3921/13/6/635
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2076-3921/13/6/635
Number of participants that the trial has enrolled
161
Results
Micronutrient antioxidants may be a viable treatment option for male infertility.
Results date posted
| 2025 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 23 | Day |
Baseline Characteristics
We recruited 171 male partners of couples experiencing infertility after at least 1 year of unprotected intercourse, and thus, requiring IVF-ICSI treatment. Male partners with non-obstructive azoospermia, obstructive azoospermia scheduled for microsurgery, severe oligozoospermia ), an identifiable cause of infertility (leukocytospermia and/or positive sperm culture, epididymal-orchitis, prostatitis, inguinoscrotal surgery, cryptorchidism, varicocele, etc.), higher BMI, endocrine, metabolic, autoimmune, or neoplastic diseases and those already taking antioxidants such as high-dose vitamin-related supplementation were excluded in this study. Female partners with diminished ovarian reserve ere excluded.
Participant flow
NA
Adverse events
None
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not available
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058693
