UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013786 |
|---|---|
| Receipt number | 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 23:43:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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
t.fujiwarabi@gmail.com
Sponsor or person
Institute
Community Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
