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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009859
Receipt No. 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

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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
Obsterics 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
Email

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
Email

Sponsor
Institute Kuramoto Women's Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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