UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012692 |
|---|---|
| Receipt number | R000014830 |
| Scientific Title | Analysis of usefulness and safety, mediatiing clinical study, measuring respiratory activity in human fertilized eggs using novel electrochemical measurement system |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/01/28 10:30:13 |
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Basic information
Public title
Analysis of usefulness and safety, mediatiing clinical study, measuring respiratory activity in human fertilized eggs using novel electrochemical measurement system
Acronym
Analysis of usefulness and safety using novel electrochemical measurement system
Scientific Title
Analysis of usefulness and safety, mediatiing clinical study, measuring respiratory activity in human fertilized eggs using novel electrochemical measurement system
Scientific Title:Acronym
Analysis of usefulness and safety using novel electrochemical measurement system
Region
| Japan |
Condition
Condition
sterility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to evaluate the usefulness and safety using novel electrochemical measurement system for human surplus fertilized eggs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality assessment of human fertilized eggs using novel electrochemical measurement system
Key secondary outcomes
Safety assessment of human fertilized eggs using novel electrochemical measurement system
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
We measure the respiratory volume in human fertilized egg using novel electrochemical measurement system for approxymately 5 minutes with slight electric current.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Human fertilized eggs within 3 days fertilization
Key exclusion criteria
Human fertilized eggs after 4 days fertilization
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Utsunomiya Hiroki |
Organization
Tohoku University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-1, Seuryo-machi, Aoba-ku, Sendai, Miyagi Pref.
TEL
022-717-7254
uskichi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Utsunomiya Hiroki |
Organization
Tohoku University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-1, Seuryo-machi, Aoba-ku, Sendai, Miyagi Pref.
TEL
022-717-7254
Homepage URL
uskichi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2015 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014830
