Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063096) titled 'Pelvic MRI Imaging Evaluation Study in Adult Women' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Rohto Pharmaceutical Co., Ltd

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate methods for evaluating fat in the ovaries and periovarian tissues in women. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 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 Size - 24

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072228

Disclaimer: Curated by HT Syndication.