UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040721
Receipt number R000046393
Scientific Title A Study on Improving Pregnancy and Infertility Treatment Literacy Using Smartphone Apps
Date of disclosure of the study information 2020/06/15
Last modified on 2021/12/06 15:11:52

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Basic information

Public title

A Study on Improving Pregnancy and Infertility Treatment Literacy Using Smartphone Apps

Acronym

A Study on Improving Pregnancy and Infertility Treatment Literacy

Scientific Title

A Study on Improving Pregnancy and Infertility Treatment Literacy Using Smartphone Apps

Scientific Title:Acronym

A Study on Improving Pregnancy and Infertility Treatment Literacy

Region

Japan


Condition

Condition

fertility

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Measurement of the effects of a smartphone application for a literacy of fertility treatment

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Scores of questionaries for fertility knowledge

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

information about fertility and fertility treatment

Interventions/Control_2

information about gynecologic disorder

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


Not applicable

Gender

Female

Key inclusion criteria

Users of the smartphone application that is applied to this study

Key exclusion criteria

Users who also use the related applications

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Akihiro
Middle name
Last name Umezawa

Organization

National Center for Child Health and Development

Division name

Center for Regenerative Medicine

Zip code

157-8535

Address

2-10-1 Okura, Setagaya, Tokyo

TEL

03-5494-7047

Email

crm@ncchd.go.jp


Public contact

Name of contact person

1st name Akihiro
Middle name
Last name Umezawa

Organization

National Center for Child Health and Development

Division name

Center for Regenerative Medicine

Zip code

157-8535

Address

2-10-1 Okura, Setagaya, Tokyo

TEL

03-5494-7047

Homepage URL


Email

crm@ncchd.go.jp


Sponsor or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



Funding Source

Organization

National Center for Child Health and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Child Health and Development

Address

2-10-1 Okura, Setagaya, Tokyo

Tel

03-3416-0181

Email

rinri@ncchd.go.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

2020 Year 06 Month 15 Day


Related information

URL releasing protocol

https://doi.org/10.1038/s41746-021-00530-4

Publication of results

Unpublished


Result

URL related to results and publications

https://doi.org/10.1038/s41746-021-00530-4

Number of participants that the trial has enrolled

4137

Results

The intervention group had a significantly higher mean post-test score compared to the control group. Furthermore, the mean difference between the post-test and pre-test scores was greater in the intervention group than in the control group. In conclusion, the educational intervention using a smartphone application contributed to the improvement of literacy about fertility treatment.

Results date posted

2021 Year 12 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Users of the smartphone application "Luna Luna"

Participant flow

After taking a 28-question pre-test for fertility literacy, participants were assigned to either the intervention or control group in a stratified randomization. The intervention group was provided with information related to fertility treatment, while the control group was provided with general information about women's health care. After the information was provided, the effect of the intervention was assessed using a post-test with the same content as the pre-test.

Adverse events

Not observed

Outcome measures

Changes in scores on a 28-question test assessing literacy about fertility treatments

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 06 Month 01 Day

Date of IRB

2020 Year 06 Month 01 Day

Anticipated trial start date

2020 Year 06 Month 18 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 06 Month 11 Day

Last modified on

2021 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046393


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name