UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041026
Receipt number 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 2022/01/06 13:33:37

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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 or person

Institute

Sugiyama clinic shinjuku

Institute

Department

Personal name



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

Value
https://center6.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