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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028541
Receipt No. R000032663
Scientific Title Examination of the ability for the treatment of 5-ALA for patients with oligozoospermia and asthenozoospermia
Date of disclosure of the study information 2017/08/04
Last modified on 2019/08/06

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Basic information
Public title Examination of the ability for the treatment of 5-ALA for patients with oligozoospermia and asthenozoospermia
Acronym Examination of the ability for the treatment of 5-ALA for patients with oligozoospermia and asthenozoospermia
Scientific Title Examination of the ability for the treatment of 5-ALA for patients with oligozoospermia and asthenozoospermia
Scientific Title:Acronym Examination of the ability for the treatment of 5-ALA for patients with oligozoospermia and asthenozoospermia
Region
Japan

Condition
Condition Male infertility
Classification by specialty
Obsterics and gynecology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are oligozoospermia and asthenozoospermia in the male infertility pathology. In those disease, on the one hand the number of active sperm is few, on the other hand sperm concentration and sperm motility are extremely low. The malfunction in reproductive cells caused by reactive oxygen species (ROS) is considered as one of the factors which affect the decline in sperm concentration. In addition, mitochondrial activity is considered as one of the factors which affect the decline in sperm motility through energy production.
Therefore, we will examine whether oral intake of 5-ALA affects sperm views (total sperm concentration, active sperm concentration, sperm motility, linearity, high speed progressive motility, progressive motility), especially sperm motility.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sperm views (sperm concentration, sperm motility, linearity, high speed progressive motility, progressive motility)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients who are cryptozoospermia or asthenozoospermia which has less effective treatments besides ICSI or who meet criteria listed below in last two sperm inspections;
1) Cryptozoospermia
meet at least one as follows;
-Total sperm concentration is not more than 1000 x 10^4/ml.
-Active sperm concentration is not more than 500 x 10^4/ml.
2) Asthenozoospermia
Sperm motility is not more than 20%.
Key exclusion criteria 1) Patients with a previous/ current history of severe disease (malignant tumor, heart disease, kidney disease and liver disease)
2) Patients who have experienced severe allergic reaction to foods and pharmaceutical products.
3) Patients whom doctors judge to be unsuitable for this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahide Shiotani
Organization Hanabusa Women's Clinic
Division name Chief director
Zip code
Address Sannomiya Central Building 7F, 1-1-2, Sannomiya-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-392-8716
Email shiotani@hanabusaclinic.com

Public contact
Name of contact person
1st name
Middle name
Last name Kohyu Furuhashi
Organization Hanabusa Women's Clinic
Division name Division of Embryo
Zip code
Address Sannomiya Central Building 7F, 1-1-2, Sannomiya-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL 078-392-8716
Homepage URL
Email furuhashi@hanabusaclinic.com

Sponsor
Institute Hanabusa Women's Clinic
Institute
Department

Funding Source
Organization neopharma Japan Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor neopharma Japan Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 04 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 Completed
Date of protocol fixation
2017 Year 07 Month 18 Day
Date of IRB
2017 Year 07 Month 31 Day
Anticipated trial start date
2017 Year 08 Month 05 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We compare the results of sperm views measured by Sperm Motility Analysis System which is used for daily treatment before and after administration of 5-ALA.

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032663

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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