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

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 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

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

Value
https://center6.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