UMIN-CTR Clinical Trial

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	Obsterics 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
Institute	National Center for Child Health and Development
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046393