UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025179 |
|---|---|
| Receipt number | R000028966 |
| Scientific Title | Comparing new vitrification media to solution currently used. |
| Date of disclosure of the study information | 2016/12/07 |
| Last modified on | 2018/06/20 17:51:10 |
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Basic information
Public title
Comparing new vitrification media to solution currently used.
Acronym
Comparing new vitrification media to solution currently used
Scientific Title
Comparing new vitrification media to solution currently used.
Scientific Title:Acronym
Comparing new vitrification media to solution currently used
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To get knowledge whether a new vitrification/warming media bring about same or better outcome compare with conventional media
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Observe the recovery condition of embryos after warming, and obtain the survival rate between the two media.
Key secondary outcomes
In addition, obtain the pregnancy rate after embryo transfer.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vitrify, warm and transfer embryos using the new vitrification/warming media by December, 2018
Interventions/Control_2
Vitrify, warm and transfer embryos using the conventional vitrification/warming media by December, 2018
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Use embryos for this study only when embryo development and morphologic evaluation achieve our standard which embryos can be vitrified.
Key exclusion criteria
When the growth of the embryos stop or when a morphologic evaluation does not achieve our standard that can enforce embryo vitrification, it is excluded from this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Utsunomiya |
Organization
St. Luke Clinic
Division name
Doctor
Zip code
Address
1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan
TEL
097-547-1234
st-luke@oct-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Kumasako |
Organization
St.Luke clinic
Division name
Laboratory
Zip code
Address
1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan
TEL
097-547-1234
Homepage URL
ykumasa@st-luke.ne.jp
Sponsor or person
Institute
St.Luke 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
セント・ルカ産婦人科（大分県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028966
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
