UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045429
Receipt number R000051871
Scientific Title Study on the effect of creatine /ergothioneine supplementation on sperm quality and ingredients in semen
Date of disclosure of the study information 2021/09/09
Last modified on 2023/03/13 15:28:54

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Basic information

Public title

Study on the effect of creatine /ergothioneine supplementation on sperm quality and ingredients in semen

Acronym

Study on supplementation of creatine/ergothioneine

Scientific Title

Study on the effect of creatine /ergothioneine supplementation on sperm quality and ingredients in semen

Scientific Title:Acronym

Study on supplementation of creatine/ergothioneine

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 quality and ingredients in semen

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

8-OHdG, creatine, zinc, testosterone, and spermine levels in semen
Fertilization rate, blastocyst delivery rate, and pregnancy rate of IVF


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of 14g creatine/ergothionein supplement daily for 2 weeks.

Interventions/Control_2

Intake of 14g sports drink like powder daily for 2 weeks.

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

50 years-old >

Gender

Male

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 or more and under 50 years old
3. Persons who visited the outpatient clinic for male infertility
4. Sperm concentration over 5 million, sperm motility over 5% and under 40%

Key exclusion criteria

1. Persons with allergies to supplement ingredients
2. Persons who take daily creatine supplement or fairy ring mushroom supplement before administration in this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazutaka
Middle name
Last name Terai

Organization

Sugiyama obstetrics and gynecology, Shinjyuku

Division name

Urology

Zip code

163-0023

Address

1-19-6 Nishishinnjyuku,Shinjyuku-ku,Tokyo,JAPAN

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 obstetrics and gynecology, Shinjyuku

Division name

Urology

Zip code

163-0023

Address

1-19-6 Nishishinnjyuku,Shinjyuku-ku,Tokyo,JAPAN

TEL

03-5381-3000

Homepage URL


Email

terai@sugiyama.or.jp


Sponsor or person

Institute

Sugiyama obstetrics and gynecology, Shinjyuku

Institute

Department

Personal name



Funding Source

Organization

Self-funding
Sugiyama obstetrics and gynecology, Shinjyuku

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

The Ethics Committee of Sugiyama obstetrics and gynecology

Address

1-19-6 Nishishinnjyuku,Shinjyuku-ku,Tokyo,JAPAN

Tel

03-5381-3000

Email

info@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

2021 Year 09 Month 09 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

8

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

2021 Year 09 Month 03 Day

Date of IRB

2021 Year 09 Month 03 Day

Anticipated trial start date

2021 Year 09 Month 13 Day

Last follow-up date

2022 Year 12 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

2021 Year 09 Month 09 Day

Last modified on

2023 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051871


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name