UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024586 |
|---|---|
| Receipt number | R000028274 |
| Scientific Title | Study on an effect of Prunus mume intake against infertility treatment |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2019/10/30 10:21:47 |
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Basic information
Public title
Study on an effect of Prunus mume intake against infertility treatment
Acronym
Study on an effect of Prunus mume intake against infertility treatment
Scientific Title
Study on an effect of Prunus mume intake against infertility treatment
Scientific Title:Acronym
Study on an effect of Prunus mume intake against infertility treatment
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify participation in infertility treatment of Prunus mume
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurements such as estradiol, progesterone,FSH, LH, AMH in serum and follicle liquid.
Cell biological and biochemical data of granulosa cells. Pregnancy rate. Fertilization rate.
Key secondary outcomes
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
| Food |
Interventions/Control_1
We give Prunus mume against the subject that normal in-vitro fertilization was unsuccessful.
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Infertility subject who the agreement was provided.
Key exclusion criteria
non
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | hirotoshi |
| Middle name | |
| Last name | Utsunomiya |
Organization
Wakayama Medical University
Division name
Department of Strategic Surveillance for Functional Food and Comprehensive Traditional Medicine
Zip code
641-0012
Address
Kimiidera 811-1, Wakayama City, Wakayama 641-0012, Japan
TEL
073-447-2300
utsu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Utsunomiya |
Organization
Wakayama Medical University
Division name
Department of Strategic Surveillance for Functional Food and Comprehensive Traditional Medicine
Zip code
6410012
Address
Kimiidera 811-1, Wakayama City, Wakayama 641-0012, Japan
TEL
073-447-2300
Homepage URL
utsu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
non
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
Wakayama Medical University
Address
Kimiidera 811-1, Wakayama City, Wakayama 641-0012, Japan
Tel
073-447-2300
utsu@wakayama-med.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
| 2016 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028274
