UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058069 |
|---|---|
| Receipt number | R000066141 |
| Scientific Title | A survey on Women's Health Issues (Infertility, Dysmenorrhea, and PMS) |
| Date of disclosure of the study information | 2025/06/03 |
| Last modified on | 2025/06/03 16:43:09 |
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Basic information
Public title
A survey on Women's Health Issues
Acronym
A survey on Women's Health Issues
Scientific Title
A survey on Women's Health Issues (Infertility, Dysmenorrhea, and PMS)
Scientific Title:Acronym
A survey on Women's Health Issues
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Survey on Women's Health Issues (Infertility, Dysmenorrhea, and PMS)
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between women's health issues and uterine blood flow.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Uterine artery pulsatility index (PI) and resistance index (RI) during the implantation period.
Key secondary outcomes
Blood flow of fingers and toes, blood pressure, and hormone levels in the blood during the implantation period.
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
1) Women aged 20-49 who could attend the examination site.
2) Women with normal menstrual cycles i.e., cycles between 25-38 days with variations in cycles within 3 days, and women who can report last 3 menstrual periods.
3) Women who have previously tried to get pregnant.
4) Women who either get pregnant within approximately six months without visiting a gynecologist after wishing to become pregnant or have more than one year of experience in trying to conceive and have experience visiting a gynecologist for fertility treatment.
5) Women with no history of gynecological diseases (such as uterine fibroids, adenomyosis, endometriosis, dysplasia, cervical cancer, etc.).
6) Women who are not currently pregnant.
7) Women who agree to the following measurements:
･Measurement of uterine artery blood flow and endometrial thickness (transabdominal ultrasound)
･Measurement of blood flow of the fingers and toes (laser Doppler)
･Blood pressure measurement
･Blood sampling (related to hormones and metabolomics)
･Collection of vaginal secretions (vaginal discharge) (for analysis of vaginal bacterial flora)
8) Women who can cooperate with the following during the participation cooperation period (1 month)
･Ovulation tests
･Body temperature measurement by applying a temperature patch sensor to the body (groin area) for one month
Key exclusion criteria
1) Women who have had a fever or respiratory symptoms themselves or in their family, or have had close contact with a person infected with the novel coronavirus, within two weeks prior to attending the examination venue.
2)Women with liver, kidney, heart disease, respiratory disorders, endocrine disorders, metabolic disorders (hypertension), neurological disorders, consciousness disorders, or diabetes, as well as those who find it difficult to participate in the study due to other illnesses.
3) Women who have undergone medication treatment or surgery due to severe illness or injury within one month prior to the start of this study and who are deemed unsuitable by the principal investigator or study staff (excluding transient symptoms such as colds or pollen allergies).
4) Women who are unable to maintain a consistent (same) intake of specific health foods, functional foods, and dietary supplements (such as capsule supplements) or exercise habits from one month prior to the start of this study.
5) Women who have participated in other pharmaceutical or food trials within the past month or who are scheduled to participate during this study period.
6) Women who have previously experienced discomfort or worsening health from blood draws.
7) Women with metal allergies or those who have a pacemaker or similar device implanted in their body.
8) Women who are not on day shifts (those who have night rotation work).
9) Women undergoing hormone replacement therapy (HRT) or taking medications that may affect hormones (including pills).
10) Women who are currently pregnant or breastfeeding.
11) Women who have experienced skin abnormalities from applying tape in the past.
12) Women deemed unsuitable for participation in this study by the principal investigator and researcher.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Yamamoto |
Organization
Kao Corporation
Division name
Biological Material Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-070-3298-2873
yamamoto.masaki@kao.com
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Tsunoda |
Organization
Kao Corporation
Division name
Human Health Care Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-70-3296-8210
Homepage URL
tsunoda.mai@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
Secondary IDs
Secondary IDs
YES
Study ID_1
23040
Org. issuing International ID_1
Kurume University Ethics Committee
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 | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Works in progress
Publication of results
Partially published
Result
URL related to results and publications
Works in progress
Number of participants that the trial has enrolled
40
Results
In the analysis
Results date posted
| 2025 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy women
Participant flow
All participants completed the study
Adverse events
No adverse events occurred
Outcome measures
Uterine artery blood flow PI, RI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Uterine artery blood flow PI, RI and infertility factors
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066141
