UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019838 |
|---|---|
| Receipt number | R000022918 |
| Scientific Title | Demonstration study for defined ART system using recombinant human albumin |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2015/12/01 09:02:14 |
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Basic information
Public title
Demonstration study for defined ART system using recombinant human albumin
Acronym
Demonstration study for defined ART system
Scientific Title
Demonstration study for defined ART system using recombinant human albumin
Scientific Title:Acronym
Demonstration study for defined ART system
Region
| Japan |
Condition
Condition
Patients receiving ART treatmetns
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the defined ART system using recombinant albumin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blastocyst rate, clinical pregnancy rate
Key secondary outcomes
Live birth rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Embryo culture in commercial media supplemented with recombinant human albumin (0.5 mg/mL rHA) for 6 days
Interventions/Control_2
Embryo culture in commercial media supplemented with human serum albumin (5 mg/mL HSA) for 6 days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with 4 or more 2PN oocytes after ART treatments using defined media
Key exclusion criteria
Oligozoospermia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Kumamoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka
TEL
092-482-5558
murakami@kuramoto.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Kumamoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka
TEL
092-482-5558
Homepage URL
murakami@kuramoto.or.jp
Sponsor or person
Institute
Kumamoto Women's Clinic
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Women's Clinic
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
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
| 2015 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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 | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022918
