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


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 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


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

Value
https://center6.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