UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063096 |
|---|---|
| Receipt number | R000072228 |
| Scientific Title | Pelvic MRI Imaging Evaluation Study in Adult Women |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/29 14:46:37 |
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Basic information
Public title
Pelvic MRI Imaging Evaluation Study in Adult Women
Acronym
Pelvic MRI Imaging Evaluation Study in Adult Women
Scientific Title
Pelvic MRI Imaging Evaluation Study in Adult Women
Scientific Title:Acronym
Pelvic MRI Imaging Evaluation Study in Adult Women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate methods for evaluating fat in the ovaries and periovarian tissues in women.
Basic objectives2
Others
Basic objectives -Others
Investigation of Methods for Assessing Ovarian Fat
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of ovarian PDFF assessment using Dixon-PDFF
Key secondary outcomes
Exploratory assessment of the feasibility and measurement characteristics of ovarian PDFF assessment
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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
[Common Criteria]
1.Premenopausal women.
2.Participants who have received a sufficient explanation of the purpose and details of the study, have understood the explanation, have voluntarily agreed to participate in the study, and have provided written informed consent.
[STEP 1]
3.Participants aged 20 to 29 years at the time of informed consent.
4.Participants who have not experienced marked deviations from their usual menstrual cycle during the past 6 months.
[STEP 2]
5.Participants aged 40 to 49 years at the time of informed consent.
6.Participants who have experienced spontaneous menstruation within 1 year prior to providing informed consent.
Key exclusion criteria
1.Participants who are pregnant, breastfeeding, may be pregnant, or for whom the possibility of pregnancy cannot be ruled out.
2.Participants with a history of oophorectomy or other gynecological surgery that may affect the anatomical morphology or position of the ovaries.
3.Participants with a history or current diagnosis of ovarian cysts, ovarian tumors, endometriosis, or other gynecological conditions that may affect ovarian identification, ROI placement, or PDFF assessment.
4.Participants currently using hormone replacement therapy, oral contraceptives, or other medications that may affect sex hormones or ovarian function.
5.Participants with metallic implants, implantable medical devices, or other conditions contraindicating MRI, or those considered unable to undergo MRI due to claustrophobia or other reasons.
6.Participants who are considered by the principal investigator or other investigators to be unsuitable for participation in the study from the perspective of safety or the validity of the study assessments.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Sekii |
Organization
Rohto Pharmaceutical Co., Ltd
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
TEL
06-6758-9848
sekii@rohto.co.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Sekii |
Organization
Rohto Pharmaceutical Co., Ltd
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
TEL
06-6758-9848
Homepage URL
sekii@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rohto Pharmaceutical Co., Ltd. Clinical Research Ethics Review Committee
Address
1-8-1 Tatsumi-nishi, Ikuno-ku, Osaka-shi, Osaka 544-8666, Japan
Tel
06-6758-6925
rohtoirb@rohto.co.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
ロート製薬株式会社・東京支社（東京都）
医療法人社団豊智会AIC八重洲クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | 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 is an exploratory observational study. Premenopausal women who meet the inclusion and exclusion criteria will be recruited through a participant recruitment company. STEP 1 will include women aged 20 to 29 years, and STEP 2 will include women aged 40 to 49 years. STEP 2 will be conducted based on the results of STEP 1. Background information, anthropometric measurements, body composition measurements using InBody, and pelvic MRI will be obtained to investigate methods for assessing fat. Recruitment for STEP 1 will begin in October 2026, and recruitment for STEP 2 will begin after evaluation of the results of STEP 1.
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072228
