UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056949 |
|---|---|
| Receipt number | R000065079 |
| Scientific Title | Survey of the obstetric and gynecological medical demand on female student athletes and coaches in the university |
| Date of disclosure of the study information | 2025/02/06 |
| Last modified on | 2025/02/06 00:14:26 |
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Basic information
Public title
Survey of the obstetric and gynecological medical demand on female student athletes and coaches in the university
Acronym
Survey of the obstetric and gynecological medical demand on female student athletes and coaches
Scientific Title
Survey of the obstetric and gynecological medical demand on female student athletes and coaches in the university
Scientific Title:Acronym
Survey of the obstetric and gynecological medical demand on female student athletes and coaches
Region
| Japan |
Condition
Condition
Gynecological disorder
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This questionnaire is to confirm the prevalence of the disorder related menstrual, the consultation rate and the intervention rate on the female athletes. In addition, it is also to confirm the understanding of the gynecological disease, the consultation and treatment. It could compare the differences between two groups and find the fact situation on the gynecologic field. The aim of this study is that these results help to build the medical support system and lead to the educational campaign.
Basic objectives2
Others
Basic objectives -Others
Survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the prevalence of the menstrual disorder
The rate of the understanding about the menstrual disorder on the female athletes and coaches
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
| 17 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Sports teams of our institution
Key exclusion criteria
Nothing
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Sari |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Obstetrics and Gynecology
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba Ibaraki
TEL
029-853-3073
s.nakao@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Nakao |
| Middle name | |
| Last name | Sari |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Obstetrics and Gynecology
Zip code
305-8575
Address
1-1-1 Tennoudai Tsukuba Ibaraki
TEL
029-853-3073
Homepage URL
s.nakao@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Tsukuba University Medical Ethics Committee
Address
1-1-1 Tennoudai Tsukuba Ibaraki
Tel
029-853-3022
sien.igakuss@un.tsukuba.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 | 02 | Month | 06 | 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 | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the questionnaire by using the google form.
Management information
Registered date
| 2025 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065079
