UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058203 |
|---|---|
| Receipt number | R000066541 |
| Scientific Title | Human blood collection study for PRP preparation and comparative experiments with culture supernatant in women of reproductive age |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/17 13:08:01 |
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Basic information
Public title
Blood collection study for preparation of PRP and comparison with stem cell culture supernatant using blood samples from women of reproductive age
Acronym
PRP and Culture Supernatant Comparison Study
Scientific Title
Human blood collection study for PRP preparation and comparative experiments with culture supernatant in women of reproductive age
Scientific Title:Acronym
Blood Collection Study for PRP and Supernatant Comparison
Region
| Japan |
Condition
Condition
Healthy volunteers (women of reproductive age)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect blood samples from women of reproductive age and prepare platelet-rich plasma (PRP), in order to obtain materials for basic research toward potential applications in infertility treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume and quality of PRP obtained from collected blood samples (assessed on the day of collection)
Key secondary outcomes
Occurrence and frequency of adverse events associated with blood collection (assessed on the day of collection and up to the following day)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Collection of approximately 100-200 mL of blood from women of reproductive age for preparation of platelet-rich plasma (PRP).
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy women of reproductive age(18 years or older, approximately up to 45 years old)
Individuals who have provided written informed consent
Key exclusion criteria
Pregnant or breastfeeding women
Individuals with severe cardiac, hepatic, renal, hematologic disorders, or bleeding tendency
Individuals with infectious diseases (e.g., hepatitis B, hepatitis C, HIV, syphilis)
Individuals deemed ineligible for participation by the investigator
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | YUUKI |
| Middle name | |
| Last name | SHIMIZU |
Organization
Nagoya University Graduate School of Medicine,Nagoya
Division name
Department of Cardiology
Zip code
466-8550
Address
7th Floor, Building 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2177
shimi123@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | YUIMI |
| Middle name | |
| Last name | MATSUOKA |
Organization
Nagoya University Graduate School of Medicine,Nagoya
Division name
Department of Cardiology
Zip code
466-8550
Address
7th Floor, Building 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2177
Homepage URL
matsuoka.yuimi.e4@s.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
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
Nagoya University Graduate School of Medicine,Nagoya
Address
7th Floor, Building 1, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2177
matsuoka.yuimi.e4@s.mail.nagoya-u.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 | 07 | 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
| 2025 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066541
