UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052077 |
|---|---|
| Receipt number | R000059432 |
| Scientific Title | Development and usability evaluation of a decision aid for couples unsure about stepping up infertility treatment. |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/09/01 07:45:01 |
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Basic information
Public title
Development and usability evaluation of a decision aid for couples unsure about stepping up infertility treatment.
Acronym
Development and usability evaluation of a decision aid for couples unsure about stepping up infertility treatment.
Scientific Title
Development and usability evaluation of a decision aid for couples unsure about stepping up infertility treatment.
Scientific Title:Acronym
Development and usability evaluation of a decision aid for couples unsure about stepping up infertility treatment.
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the content and surface validity of a prototype version of a decision-making aide for stepping up to advanced assisted reproductive technology and termination of treatment for infertile couples, and to evaluate its usability among medical professionals and people who have undergone infertility treatment.
Basic objectives2
Others
Basic objectives -Others
validation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Reproductive medicine specialist
Nurses and midwives involved in infertility care nursing
Former patients who have experienced ART or terminated infertility treatment
Key exclusion criteria
Unable to obtain written consent
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
+81357795031
k-asazawa@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
+81357795031
Homepage URL
k-asazawa@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Tokyo Healthcare University
Address
4-1-17 higashigotanda, Shinagawa-ku, Tokyo
Tel
0354217655
kenkyo@thcu.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
| 2023 | Year | 09 | Month | 01 | 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
22
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
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059432
