UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041387 |
|---|---|
| Receipt number | 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 | 2024/04/06 09:16:21 |
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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
| Obstetrics 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
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
koitomo@dokkyomed.ac.jp
Sponsor or person
Institute
Division of The International Center for Reproductive Medicine, Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
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
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
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://mol.medicalonline.jp/library/journal/download?GoodsID=fn7psych/2021/000701/002&name=0006-001
Number of participants that the trial has enrolled
911
Results
As a result, 59.6% of the patients continued their fertility treatments in April and May 2020, whereas 27.3% of the patients cancelled the consultation due to COVID-19. Of those who had treatment canceled, 80.5% found it to be upsetting and 5.7% found it not upsetting. About 60% had poor mental health regardless of whether they continued or cancelled their treatment in April or May 2020. About 60% or more patients took appropriate stress coping behavior.
Results date posted
| 2022 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 04 | Day |
Baseline Characteristics
The patients who are in the treatments (Survey 1) and the people who quitted from infertility treatments at April-May 2020 (Survey 2).
Participant flow
After explaining their participation in the study in writing and obtaining their consent, the participants were asked to complete a web-based questionnaire once at the time of participation.
Adverse events
Nothing.
Outcome measures
The concerns for going to the fertility treatments and the cancellation of the fertility treatment and psychological distress from April to May 2020. WHO-5, the stress-coping and the needs for support questionnaire.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
| 2024 | Year | 03 | Month | 31 | Day |
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.
Now data analyzing.
Management information
Registered date
| 2020 | Year | 08 | Month | 11 | 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=R000047141
| 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 |
