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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041387
Receipt No. R000047141
Scientific Title Japan COVID-19 Study of the psychosocial impacts of the postponement/cancellation of reproductive medicine
Date of disclosure of the study information 2020/08/11
Last modified on 2021/04/02

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Basic information
Public title Japan COVID-19 Study of the psychosocial impacts of the postponement/cancellation of reproductive medicine
Acronym Japan COVID-19 Study of the psychosocial impacts of the postponement/cancellation of reproductive medicine
Scientific Title Japan COVID-19 Study of the psychosocial impacts of the postponement/cancellation of reproductive medicine
Scientific Title:Acronym Japan COVID-19 Study of the psychosocial impacts of the postponement/cancellation of reproductive medicine
Region
Japan

Condition
Condition Infertility or fertility preservation for medical reasons.
Classification by specialty
Obsterics and gynecology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the impact of the postponement/cancellation of reproductive medicine on psychosocial distress, stress coping strategies, and support needs under the spread of coronavirus (COVID-19) infection.
Basic objectives2 Others
Basic objectives -Others Observational study
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Impact of the postponement/cancellation of reproductive medicine by coronavirus on psychosocial distress and activity toward pregnancy
Key secondary outcomes Reproductive medical examination behavior, psychosocial stress, stress coping strategies, support needs, and reasons for discontinuing treatment

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

Not applicable
Gender Male and Female
Key inclusion criteria Males and females at the legal age of adulthood in infertility and medically assisted reproduction (i.g., IUI, oocyte retrievals, embryo transfer, TESE).
Key exclusion criteria Couples who finish treating reproductive medicine due to pregnancy.
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name Kouhei
Middle name
Last name Sugimoto
Organization Dokkyo Medical University Saitama Medical Center
Division name The International Center for Reproductive Medicine
Zip code 343-8555
Address 2-1-50 Minamikoshigaya, Koshigaya city, JAPAN
TEL 048-965-2028
Email kouhei-s@dokkyomed.ac.jp

Public contact
Name of contact person
1st name Tomoe
Middle name
Last name Koizumi
Organization Dokkyo Medical University Saitama Medical Center
Division name The International Center for Reproductive Medicine
Zip code 343-8555
Address 2-1-50 Minamikoshigaya, Koshigaya city, JAPAN
TEL 048-965-2028
Homepage URL
Email koitomo@dokkyomed.ac.jp

Sponsor
Institute Division of The International Center for Reproductive Medicine, Dokkyo Medical University Saitama Medical Center
Institute
Department

Funding Source
Organization The research grant of the Japan Society for Reproductive Psychology, #JSRP-006.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor The committee for reproductive medicine and psychosocial care in COVID-19
pandemic and emergency settings
Name of secondary funder(s)

IRB Contact (For public release)
Organization Bioethics Committee Saitama Medical Center Dokkyo Medical University
Address 2-1-50 Minamikoshigaya, Koshigaya city, JAPAN
Tel 048-965-1111
Email m--iyama@dokkyomed.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
2020 Year 08 Month 11 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
2020 Year 08 Month 07 Day
Date of IRB
2020 Year 08 Month 07 Day
Anticipated trial start date
2020 Year 08 Month 17 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Study 1;
A web-based survey of male and female patients undergoing reproductive treatment.

Study 2;
A web-based survey of male and female patients who have discontinued reproductive treatment due to COVID-19 in April 2020.

Management information
Registered date
2020 Year 08 Month 11 Day
Last modified on
2021 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047141

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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