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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013452
Receipt No. R000015711
Scientific Title Randomized study on evaluating microfluidic devices using sperms for clinical sample
Date of disclosure of the study information 2014/03/18
Last modified on 2017/04/17

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Basic information
Public title Randomized study on evaluating microfluidic devices using sperms for clinical sample
Acronym Evaluation of microfluidic devices using sperms for clinical sample
Scientific Title Randomized study on evaluating microfluidic devices using sperms for clinical sample
Scientific Title:Acronym Evaluation of microfluidic devices using sperms for clinical sample
Region
Japan

Condition
Condition Male infertility
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usability of (1) paper-based device and (2) sperm concentrating device using semen and sperm after infertility treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes (1) Paper-based device: The yellowish 3-(4,5-dimethyl thiazol-2-yl)-2,5-diphenyl tetrazolium salt (MTT) is a substrate of mitochondrial dehydrogenase enzyme, which, upon removal of the bromide, converts to insoluble purple MTT formazan. Through a combination of patterned papers and the enzymatic reaction with human sperm, we can estimate the motility of human sperm (in order to monitor the quality of human sperm) at home without using a microscope in a clinic.
(2) Sperm concentrating device: We compare the time of adsorption onto micro-beads as a model of embryos, and evaluate the required time for fertilization.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 (1)Taking pictures of paper-based devices after semen application

(2)Evaluation for in vitro fertilization using micro-beads as model of embryos

Male fertility case
Interventions/Control_2 Male infertility case
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Sperms of patients in assisted reproductive center of Miyake Clinic
Key exclusion criteria No standard
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsuura
Organization Okayama University
Division name Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address Tsushima-naka 3-1-1 Kita-ku, Okayama, Japan
TEL 086-251-8610
Email kojimatu@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsuura
Organization Okayama University
Division name Cardiovascular Physiology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Zip code
Address Tsushima-naka 3-1-1 Kita-ku, Okayama, Japan
TEL 086-251-8610
Homepage URL
Email kojimatu@md.okayama-u.ac.jp

Sponsor
Institute IRB in Okayama University
Institute
Department

Funding Source
Organization Okayama Foundation for Science and Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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 03 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0015028215012571
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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 18 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015711

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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