UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049691 |
|---|---|
| Receipt number | R000056598 |
| Scientific Title | Study on the effect of creatine /ergothioneine supplementation on sperm motility and in vitro fertilization |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2023/12/05 09:23:50 |
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Basic information
Public title
Study on the effect of creatine /ergothioneine supplementation on sperm motility and in vitro fertilization
Acronym
Study on the effect of creatine /ergothioneine supplementation on sperm motility and in vitro fertilization
Scientific Title
Study on the effect of creatine /ergothioneine supplementation on sperm motility and in vitro fertilization
Scientific Title:Acronym
Study on the effect of creatine /ergothioneine supplementation on sperm motility and in vitro fertilization
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of creatine /ergothioneine supplements on sperm motility and in vitro fertilization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Semen volume, sperm count, and
sperm motility
Key secondary outcomes
Sperm motility in automated analyzers(VAP,VSL,VCL,ALH)
8-OHdG, creatine, zinc, testosterone, and spermine levels in semen
Fertilization rate, blastocyst delivery rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 14g creatine/ergothionein supplement daily for 2 weeks
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2)Healthy Japanese who are 20 years old
3)Sperm concentration over 5 million, sperm motility over 5%
4)Patients who visit an outpatient infertility clinic and are scheduled to undergo IVF
Key exclusion criteria
1) Persons who have chronic diseases and are under medication, history of serious diseases, infectious diseases such as HIV, hepatitis B, hepatitis C, syphilis, etc.
2) Persons who are allergic to the test food
3)Persons who take test food daily before administration in this study
4) Those who have participated in other studies during one month prior to the start of the study, or who plan to participate in other studies after consenting to this study
5) Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Kawai |
Organization
Kameda IVF Clinic MakuhariMakuhari
Division name
hospital department
Zip code
261-8501
Address
Makuhari Techno Garden D-3F, Nakase 1-3, Mihama-ku, Chiba-City, Chiba
TEL
043-296-8141
kawai.kiyotaka@kameda.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Yoshimura |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales and Planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
yoshimura@hc-sys.jp
Sponsor or person
Institute
Kameda IVF Clinic Makuhari
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.jp
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
| 2022 | Year | 12 | Month | 05 | 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
0
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
Terminated
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056598
