UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030293 |
|---|---|
| Receipt number | R000034597 |
| Scientific Title | Randomized controlled trial on the effects of the e-learning fertility education program for the female students after high school graduation |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2019/03/31 21:06:22 |
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Basic information
Public title
Randomized controlled trial on the effects of the e-learning fertility education program for the female students after high school graduation
Acronym
The effects of the fertility education program
Scientific Title
Randomized controlled trial on the effects of the e-learning fertility education program for the female students after high school graduation
Scientific Title:Acronym
The effects of the fertility education program
Region
| Japan |
Condition
Condition
The unmarried female students after high school graduation, excluding medical student.
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of the fertility education program
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of the Cardiff Fertility Knowledge Scale Japanese version
Key secondary outcomes
The awareness of fertility
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The fertility education program(pregnancy and fertility)
Interventions
Interventions/Control_2
The fertility education program(pregnancy)
Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
The unmarried female students
Key exclusion criteria
The medical student
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | Azuma |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1500012
Address
4-1-3,Hiroo,Shibuya-ku,Tokyo
TEL
03-3409-1026
s-azuma@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Sonoko |
| Middle name | |
| Last name | Azuma |
Organization
Japanese Red Cross College of Nursing
Division name
Faculty of Nursing
Zip code
1500012
Address
4-1-3,Hiroo,Shibuya-ku,Tokyo
TEL
03-3409-1026
Homepage URL
s-azuma@redcross.ac.jp
Sponsor or person
Institute
The Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross College of Nursing
Address
4-1-3,Hiroo,Shibuya-ku,Tokyo
Tel
03-3409-1026
s-azuma@redcross.ac.jp
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
| 2017 | Year | 12 | Month | 07 | 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
100
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
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034597
