UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057341 |
|---|---|
| Receipt number | R000065318 |
| Scientific Title | for young women with ovarian insufficiency, creative effective information provision and supportive shared-decision-making study |
| Date of disclosure of the study information | 2025/03/24 |
| Last modified on | 2025/03/19 16:08:36 |
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Basic information
Public title
for young women with ovarian insufficiency, creative effective information provision and supportive shared-decision-making study
Acronym
FOCASS study
Scientific Title
for young women with ovarian insufficiency, creative effective information provision and supportive shared-decision-making study
Scientific Title:Acronym
FOCASS study
Region
| Japan |
Condition
Condition
ovarian insufficiency
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine optimal support for young patients with ovarian insufficiency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mental health
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention group will receive treatment explanations and discussions before treatment, and 6, 12, and 15 months after treatment.
Interventions/Control_2
The control group will not receive the above intervention.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Patients under 40 years of age with ovarian insufficiency.
Key exclusion criteria
nothing
Target sample size
140
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
International Center for Reproductive Medicine
Zip code
343-8555
Address
2 Chome, 1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
kouhei-s@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Takekawa |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
International Center for Reproductive Medicine
Zip code
343-8555
Address
2 Chome, 1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
TEL
048-965-1111
Homepage URL
y-takekawa@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for The Promotion Of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Saitama Medical Center
Address
2 Chome, 1-50 Minamikoshigaya, Koshigaya, Saitama, Japan
Tel
048-965-1111
k-shien@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
| 2025 | Year | 03 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065318
