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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012692
Receipt No. 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

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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
Obsterics 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
Email 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
Email uskichi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014830

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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