UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031795 |
|---|---|
| Receipt number | R000036292 |
| Scientific Title | Sperm immobilization test using cryopreserved sperm preparation applied with computer-aided sperm analysis (CASA) |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2023/03/23 17:54:14 |
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Basic information
Public title
Sperm immobilization test using cryopreserved sperm preparation applied with computer-aided sperm analysis (CASA)
Acronym
Sperm immobilization test using cryopreserved sperm preparation applied with computer-aided sperm analysis (CASA)
Scientific Title
Sperm immobilization test using cryopreserved sperm preparation applied with computer-aided sperm analysis (CASA)
Scientific Title:Acronym
Sperm immobilization test using cryopreserved sperm preparation applied with computer-aided sperm analysis (CASA)
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve SIT(sperm immobilization test)
Basic objectives2
Others
Basic objectives -Others
To improve SIT(sperm immobilization test)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In SIT using the fresh and the frozen-thawed sperm, the results are identical.
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
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
SIT positive 25 samples and
SIT negative 25 samples
Key exclusion criteria
45 years-old or above
20 years-old or below
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Shibahara |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynaecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
+81-798-45-6481
sibahara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Wakimoto |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynaecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 663-8501, Japan
TEL
+81-798-45-6481
Homepage URL
yuuwakimoto@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine Obstetrics and Gynaecology
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
Hyougo Colledge of Medicine
Address
1-1 Mukogawa-cho
Tel
0798456481
yuuwakimoto@gmail.com
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
70
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036292
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
