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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013786
Receipt No. R000016094
Scientific Title The diagnostic accuracy of home pregnancy test kit for adult male: a single center, prospective observational study.
Date of disclosure of the study information 2014/04/22
Last modified on 2017/01/03

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Basic information
Public title The diagnostic accuracy of home pregnancy test kit for adult male: a single center, prospective observational study.
Acronym Home pregnancy test for adult male
Scientific Title The diagnostic accuracy of home pregnancy test kit for adult male: a single center, prospective observational study.
Scientific Title:Acronym Home pregnancy test for adult male
Region
Japan

Condition
Condition pregnancy
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the diagnostic accuracy of home pregnancy kit for adult male
Basic objectives2 Others
Basic objectives -Others diagnostic accuracy
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The sensitivity and specificity of home pregnancy kit
The reference standard were presence of fetal heart beating with transabdominal ultrasonography at (at least) 6 week after index test (home pregnancy test).
Key secondary outcomes positive and negative predictive value

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
55 years-old >=
Gender Male
Key inclusion criteria healthcare providers or medical students
Key exclusion criteria People who had known serious heart, renal, hepatic disease were excluded. Furthermore, people who have diabetes mellitus and had history of testicular tumor were excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Fujiwarabi
Organization Ehime University Hospital
Division name Otolaryngology Head and Neck Surgery
Zip code
Address Shitsukawa, Toon city, Ehime
TEL 089-956-3356
Email t.fujiwarabi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Fujiwara
Organization Ehime University Hospital
Division name Otolaryngology Head and Neck Surgery
Zip code
Address Shitsukawa, Toon city, Ehime
TEL 089-956-3356
Homepage URL
Email t.fujiwarabi@gmail.com

Sponsor
Institute Community Medicine
Institute
Department

Funding Source
Organization None
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
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 Ehime University Hospital

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 22 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 Completed
Date of protocol fixation
2014 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information We did a single-centre, prospective observational study to assessed the diagnostic accuracy of home pregnancy test kit for adults male. This study was conducted in Ehime University from 1 May 2014 to 31 July 2014. The study was conducted and reported in accordance with Standards for Reporting of Diagnostic Accuracy STARD principles.

Management information
Registered date
2014 Year 04 Month 22 Day
Last modified on
2017 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016094

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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