UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016560 |
|---|---|
| Receipt number | 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 19:46:53 |
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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
| Obstetrics 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
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
Thomas.ebner@gespag.at
Sponsor or person
Institute
Privatklinik Goldenes Kreuz
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
None
Name of secondary funder(s)
Not applicable
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019215
