UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047964 |
|---|---|
| Receipt number | R000054657 |
| Scientific Title | Study for overcoming the severe infertility by new indole compound (MA-5) |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2024/01/04 16:08:37 |
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Basic information
Public title
Study for overcoming the severe infertility by new indole compound (MA-5)
Acronym
Study for overcoming the severe infertility by new indole compound (MA-5)
Scientific Title
Study for overcoming the severe infertility by new indole compound (MA-5)
Scientific Title:Acronym
Study for overcoming the severe infertility by new indole compound (MA-5)
Region
| Japan |
Condition
Condition
infertility patients
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is to investigate effect of New indole compound (MA-5: Mitochonic acid-5) on on mitochondrial function of sperm, in order to apply for human assisted reproductive technology (ART).
Basic objectives2
Others
Basic objectives -Others
Exploration of an effect of new drug
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using discarded sperm, effect of MA-5 exposure is evaluated for sperm function (kinetics and fertilization ability) and mitochondrial function (ART production), and it is compared with non-treated counterpart.
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
| 20 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Male
Key inclusion criteria
Infertility patient, No matter reason for infertility, Age between 20 to 42, Male
Key exclusion criteria
Patient who has infection, such as hepatitis B virus, hepatitis C virus, Syphilis and HIV.
Patient who has been registered to other clinical study.
Patient who are using supplement drugs which affects mitochondrial function, such as Vit C&E, CoQ10 etc.
Sample may not be used if the sperm parameter is not enough to analyze, even if patient eligible to enter this study and agreed.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university graduate school of medicine
Division name
Department of perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
masahito.tachibana.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahito |
| Middle name | |
| Last name | Tachibana |
Organization
Tohoku university hospital
Division name
Dept of OB/GYN
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177254
Homepage URL
http://www.ob-gy.med.tohoku.ac.jp/index.html
masahito.tachibana.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
| 2022 | Year | 07 | Month | 01 | 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
13
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 | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054657
| 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 |
