UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009859 |
|---|---|
| Receipt number | R000011551 |
| Scientific Title | Defined embryo vitrification procedure with recombinant human albumin: a randomised clinical trial |
| Date of disclosure of the study information | 2013/01/24 |
| Last modified on | 2013/01/24 15:12:50 |
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Basic information
Public title
Defined embryo vitrification procedure with recombinant human albumin: a randomised clinical trial
Acronym
Defined embryo vitrification procedure with recombinant human albumin: a randomised clinical trial
Scientific Title
Defined embryo vitrification procedure with recombinant human albumin: a randomised clinical trial
Scientific Title:Acronym
Defined embryo vitrification procedure with recombinant human albumin: a randomised clinical trial
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the usefulness and safety of the defined vitrification procedure for human blastocysts
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcomes of vitrified-warmed embryo transfer (ET)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Blastocysts are vitrified-warmed in the solutions containig recombinant human albumin
Interventions/Control_2
Blastocysts are vitrified-warmed in the solutions containig human serum albumin
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
| 24 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients from our IVF centre undergoing elective cryopreservation of all embryos at the blastocyst stage
Key exclusion criteria
Patinets from our IVF centre other than the above critera
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Kuramoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kuramoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kuramoto Women's Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 01 | Month | 24 | 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
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Last modified on
| 2013 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011551
