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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035124
Receipt No. R000040035
Official scientific title of the study 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 2018/12/11

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Basic information
Official scientific title of the study survey on counseling and psychosocial care for fertility preservation and IVF/ICSI treatment
Title of the study (Brief title) 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 Obsterics 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 Nao Suzuki
Organization St. Marianna University School of Medicine
Division name Department of Obstetrics and Gynecology
Address 2-16-1 Sugao, Miyamae, Kawasaki City, Japan
TEL 044-977-8111
Email nao@marianna-u.ac.jp

Public contact
Name of contact person Tomoe Koizumi
Organization St. Marianna University School of Medicine
Division name Department of Obstetrics and Gynecology
Address 2-16-1 Sugao, Miyamae, Kawasaki City, Japan
TEL 044-977-8111
Homepage URL
Email tomoe.koizumi@marianna-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology,
St. Marianna University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 12 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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