UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035124 |
|---|---|
| Receipt number | R000040035 |
| Scientific Title | survey on counseling and psychosocial care for fertility preservation and IVF/ICSI treatment |
| Date of disclosure of the study information | 2018/12/04 |
| Last modified on | 2024/04/06 09:13:44 |
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Basic information
Public title
survey on counseling and psychosocial care for fertility preservation and IVF/ICSI treatment
Acronym
Psychosocial care system International survey
Scientific Title
survey on counseling and psychosocial care for fertility preservation and IVF/ICSI treatment
Scientific Title:Acronym
Psychosocial care system International survey
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Infertility patients without cancer, Cancer patietns considering fertility preservation, Health care providers
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the survey is to examine whether and how you provide counseling and psychosocial care of fertility preservation for cancer patients and of IVF/ICSI treatment for non-cancer patients respectively.
Basic objectives2
Others
Basic objectives -Others
N
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaire about psychosocial care system
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Board members, representatives of the below organizations; Asian Society for Fertility Preservation Board Member, Oncofertility Consortium Global Partner, International Infertility Counseling Organization, European Society of Human Reproduction and Endocrinology Psychology Special Interest Group, American Society for Reproductive Medicine Mental Health Professional Group.
Key exclusion criteria
Non-members of the below organizations; Asian Society for Fertility Preservation Board Member, Oncofertility Consortium Global Partner, International Infertility Counseling Organization, European Society of Human Reproduction and Endocrinology Psychology Special Interest Group, American Society for Reproductive Medicine Mental Health Professional Group.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nao |
| Middle name | |
| Last name | Suzuki |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki City, Japan
TEL
044-977-8111
nao@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Koizumi |
Organization
St. Marianna University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki City, Japan
TEL
044-977-8111
Homepage URL
tomoe.koizumi@marianna-u.ac.jp
Sponsor or person
Institute
Department of Obstetrics and Gynecology,
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS Kakenhi 17H0456
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki City, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 04 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To submit Journals.
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cross sectional study about psychosocial care system for cancer patients considering fertility preservation and non-cancer patients with subfertility.
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040035
| 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 |
