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
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
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
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
