UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052078 |
|---|---|
| Receipt number | R000059433 |
| Scientific Title | Evaluation of decision aids for couples considering stepping up infertility treatment: a feasibility study |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2023/10/21 09:31:33 |
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Basic information
Public title
Evaluation of decision aids for couples considering stepping up infertility treatment: a feasibility study
Acronym
Evaluation of decision aids for couples considering stepping up infertility treatment: a feasibility study
Scientific Title
Evaluation of decision aids for couples considering stepping up infertility treatment: a feasibility study
Scientific Title:Acronym
Evaluation of decision aids for couples considering stepping up infertility treatment: a feasibility study
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the feasibility of using decision aids to assist infertile couples in stepping up to advanced assisted reproductive technology and terminating treatment
Basic objectives2
Others
Basic objectives -Others
Identify changes in decision-making conflicts
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decision-making conflict
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
Couples undergoing general fertility treatment who are considering ART or who are considering discontinuing treatment
Key exclusion criteria
Unable to obtain written consent
Target sample size
25
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
0357795031
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
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 | 07 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | 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 | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059433
