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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041026
Receipt No. R000046852
Scientific Title Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen =
Date of disclosure of the study information 2020/07/07
Last modified on 2020/07/07

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Basic information
Public title Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen =
Acronym Study on Antioxidant Effect of Pleurotus cornucopiae
Scientific Title Study on Antioxidant Effect of Pleurotus cornucopiae = Evaluation using 8-OHdG in semen =
Scientific Title:Acronym Study on Antioxidant Effect of Pleurotus cornucopiae
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Endocrinology and Metabolism Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the antioxidant effect and the effect on semen findings of Pleurotus cornucopiae.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Semen findings (volume, concentration, sperm motility)
Semen components (creatine concentration,8-OHdG concentration)
before and after ingesting the test food
Key secondary outcomes In vitro fertilization index (fertilization rate, blastocyst arrival rate, pregnancy rate, etc.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take 6 tablets of biogot tablets, which are tamugitake supplements, 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
Key inclusion criteria 1. Patients who visited a male infertility clinic.
2. Semen findings: Sperm concentration: 5 million/ml or more, Sperm motility: 5% or more
3. Men over 20 years old
Key exclusion criteria 1.Those who are allergic to the components of the supplement
2.Those who have taken biogot supplements or Tamogi bamboo supplements before administration
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazutaka
Middle name
Last name Terai
Organization Sugiyama clinic shinjuku
Division name Urology department
Zip code 160-0023
Address 1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
TEL 03-5381-3000
Email terai@sugiyama.or.jp

Public contact
Name of contact person
1st name Kazutaka
Middle name
Last name Terai
Organization Sugiyama clinic shinjuku
Division name Urology department
Zip code 160-0023
Address 1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
TEL 03-5381-3000
Homepage URL
Email terai@sugiyama.or.jp

Sponsor
Institute Sugiyama clinic shinjuku
Institute
Department

Funding Source
Organization Dantte 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 Sugiyama clinic
Address 1-19-6 Nishi Shinjuku, Shinjuku-ku, Tokyo Yamate Shinjuku Building
Tel 03-5381-3000
Email terai@sugiyama.or.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
2020 Year 07 Month 07 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 22 Day
Date of IRB
2020 Year 06 Month 22 Day
Anticipated trial start date
2020 Year 07 Month 07 Day
Last follow-up date
2021 Year 05 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
2020 Year 07 Month 07 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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