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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030293
Receipt No. 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

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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
Email 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
Email s-azuma@redcross.ac.jp

Sponsor
Institute The Japanese Red Cross College of Nursing
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034597

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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