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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016560
Receipt No. R000019215
Scientific Title E-motion: tilting embryo culture in IVF using bench top incubators
Date of disclosure of the study information 2015/02/17
Last modified on 2015/09/29

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Basic information
Public title E-motion: tilting embryo culture in IVF using bench top incubators
Acronym E-motion
Scientific Title E-motion: tilting embryo culture in IVF using bench top incubators
Scientific Title:Acronym E-motion
Region
Europe

Condition
Condition In vitro culture of human oocytes/embryos to blastocyst stage using tilting embryo culture
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether tilting embryo culture in a prospective randomized approach gives better embryo development and pregnancy rates
Basic objectives2 Others
Basic objectives -Others To prove that using smaller bench top incubators does allow for tilting embryo culturre
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes clinical pregnancy rate
Key secondary outcomes blastocyst development
miscarriage rate
live birth rate
implantation rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tilting embryo culture
Interventions/Control_2 Conventional static embryo culture
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
18 years-old <
Age-upper limit
40 years-old >=
Gender Female
Key inclusion criteria ICSI with at least three MII-oocytes
Key exclusion criteria Adjuvant therapy to increase rates of implantation and pregnancy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MSC Sonja Traunfellner
Organization Privatklinik Goldenes Kreuz, Vienna, Austria, Europe
Division name IVF-Unit
Zip code
Address Lazarettgasse 16-18, A-1090 Vienna
TEL +81-04301401115400
Email Sonja.traunfellner@kinderwunschzentrum.at

Public contact
Name of contact person
1st name
Middle name
Last name Prof. Dr. Thomas Ebner
Organization Landes- Frauen- and Kinderklinik, Linz, Austria, Europe
Division name Kinderwunsch Zentrum
Zip code
Address Krankenhausstr. 26-30, A-4020 Linz
TEL +81-043732692324605
Homepage URL http://www.ivf-linz.at
Email Thomas.ebner@gespag.at

Sponsor
Institute Privatklinik Goldenes Kreuz
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) Not applicable

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 Privatklinik Goldenes Kreuz
Kinderwunschzentrum
Vienna, Austria, Europe

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 17 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 Enrolling by invitation
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
2015 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 17 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019215

Research Plan
Registered date File name
2015/11/19 Studien Design SS Rate.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/08/22 083CRF.docx


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