UMIN-CTR Clinical Trial

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	20
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	Completed
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	2022 Year 01 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046852