UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050023 |
|---|---|
| Receipt number | R000056989 |
| Scientific Title | Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility: a randomized double blind placebo controlled study |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2024/03/13 08:20:48 |
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Basic information
Public title
Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility: a randomized double blind placebo controlled study
Acronym
Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility: a randomized double blind placebo controlled study
Scientific Title
Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility: a randomized double blind placebo controlled study
Scientific Title:Acronym
Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility: a randomized double blind placebo controlled study
Region
| Africa |
Condition
Condition
male infertility
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of D-aspartic acid, Zinc and Co-enzyme Q 10 supplementation on different semen parameters in idiopathic male infertility
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of different semen parameters
Key secondary outcomes
change in free testosterone level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A will d-aspartic acid daily for 3 months
Interventions/Control_2
Group B will receive placebo daily for 3 months
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
| 25 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Any infertile male aged 25 to 40 years old suffering from idiopathic infertility will be included
Key exclusion criteria
Any idiopathic infertile male suffering from varicocele or leukocytospermia or immunological infertility will be excluded. Finally, any infertile patient with small testicular volume < 8 ml will be also excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo university
Division name
Andrology
Zip code
002
Address
New Cairo
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo university
Division name
Andrology
Zip code
002
Address
New cairo
TEL
01227109309
Homepage URL
https://medicine.cu.edu.eg/.../124-kasralainy-school-of-medicine
samehfayek@kasralainy.edu.eg
Sponsor or person
Institute
Cairo university
Institute
Department
Personal name
sameh fayek gamalel din
Funding Source
Organization
parkville pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Egyptian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasr Alainy faculty of medicine
Address
New Cairo
Tel
01227109309
samehfayek@kasralainy.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
Sameh fayek gamalel din
Org. issuing International ID_1
Cairo university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 14 | 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
100
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
