UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020278 |
|---|---|
| Receipt number | R000023410 |
| Scientific Title | The effect of infertility patients by the oral administration of DHEA |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/01/07 13:32:29 |
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Basic information
Public title
The effect of infertility patients by the oral administration of DHEA
Acronym
The effect of infertility patients by the oral administration of DHEA
Scientific Title
The effect of infertility patients by the oral administration of DHEA
Scientific Title:Acronym
The effect of infertility patients by the oral administration of DHEA
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of DHEA for poor responder to ovarian stimulation for in vitro fertilization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
increase in the number of oocyte
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Twice daily oral DHEA capsules 25mg, continued for half a year
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
Appling to or more of the following two points and having IVF treatment more than six months
Key exclusion criteria
Having other adjunctive therapy
Pregnant,nursing or possibility of them
Determined that they are not appropriate by attending physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ogaki Yoko |
Organization
St Luke international hospital
Division name
OBGY
Zip code
Address
9-1 Akashi Chuo Tokyo
TEL
03-3541-5151
yogaki@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ogaki Yoko |
Organization
St Luke international hospital
Division name
OBGY
Zip code
Address
9-1 Akashi Chuo Tokyo
TEL
03-3541-5151
Homepage URL
yogaki@luke.ac.jp
Sponsor or person
Institute
St Luke international hospital
Institute
Department
Personal name
Funding Source
Organization
St Luke international hospital
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
Address
Tel
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 | 01 | 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
| 2015 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 19 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023410
