UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016168 |
|---|---|
| Receipt number | R000018473 |
| Scientific Title | Effects of fertility information on people's knowledge, life-planning, and psychology |
| Date of disclosure of the study information | 2015/01/13 |
| Last modified on | 2020/01/13 10:53:30 |
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Basic information
Public title
Effects of fertility information on people's knowledge, life-planning, and psychology
Acronym
Effects of fertility information
Scientific Title
Effects of fertility information on people's knowledge, life-planning, and psychology
Scientific Title:Acronym
Effects of fertility information
Region
| Japan |
Condition
Condition
Healthy men and women who hope to have children in the future, excluding those who or whose partners are currently pregnant.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of fertility information on people's knowledge, life-planning, and psychology.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of people who felt anxiety
Key secondary outcomes
The score of the Cardiff Fertility Knowledge Scale
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Fertility information (Intervention)
Interventions/Control_2
Information about intake of folic acid during pregnancy (Control 1)
Interventions/Control_3
Information about public financial supports for having children (Control 2)
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women who hope to have children in the future
Key exclusion criteria
Those who or whose partners are currently pregnant
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Saito |
Organization
National Center for Child Health and Development
Division name
Center of Maternal-Fetal, Neonatal and Reproductive Medicine,
Zip code
157-0074
Address
2-10-1, Okura, Setagaya, Tokyo
TEL
+81-3-3416-0181
saitou-hi@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University
Division name
Public Health
Zip code
010-8543
Address
1-1-1, Hondo Akita
TEL
+81-18-884-6087
Homepage URL
kuwayama-tky@umin.ac.jp
Sponsor or person
Institute
National Center for Child Health and Development, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
National Center for Child Health and Development, Tokyo, 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
Akita University
Address
1-1-1 Hondo Akita, Japan
Tel
81-18-884-6087
erimaeda@med.akita-u.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
| 2015 | Year | 01 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27301362
Number of participants that the trial has enrolled
1455
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
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2015 | Year | 01 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018473
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
