UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021691 |
|---|---|
| Receipt number | R000024996 |
| Scientific Title | Evaluation the effect of group culture in WOW dishes of human embryos on embryo development |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/02/13 20:23:54 |
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Basic information
Public title
Evaluation the effect of group culture in WOW dishes of human embryos on embryo development
Acronym
Effect of group culture in WOW dishes of human embryos on embryo development
Scientific Title
Evaluation the effect of group culture in WOW dishes of human embryos on embryo development
Scientific Title:Acronym
Effect of group culture in WOW dishes of human embryos on embryo development
Region
| Japan |
Condition
Condition
Obstetrics and gynecology
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In bovine, less than 10% of the embryos developed to the blastocyst stage when embryos are cultured individually, however when the embryos are cultured in groups, 25-35% of the embryos developed to the blastocysts. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of growth factors, which are secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using Veeck criteria for classification for cleaved embryos on day-3 and Gardner criteria for classification for blastocysts on day-5, 6 and 7, we compare the rates of the blastocyst development and good quality blastocyst development between WOW group and control group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
WOW dish culture(group culture)
Interventions/Control_2
Individual 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
| 20 | years-old | <= |
Age-upper limit
| 43 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients whose embryos were fertilized by Conventional IVF/ICSI
Patients who had at least 3 fertilized oocytes (2PN)
Patients whose whole 2PN embryos were cultured to the blastocyst stage
Key exclusion criteria
Patients who were pointed out that there were an abnormality in the chromosome analysis.
Patients who had severely male factor and had to use testicular, epididymis and frozen sperm.
Patients who had a severe disease of internal organ.
Patients who were decided to be unsuitable for this study by doctors and researchers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishikawa |
Organization
Tokyo Medical and Dental University
Division name
Comprehensive Reproductive Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5322
t.ishikawa.crm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishikawa |
Organization
Tokyo Medical and Dental University
Division name
Comprehensive Reproductive Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL
03-5803-5322
Homepage URL
t.ishikawa.crm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Dai Nipponn Printing Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | 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
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024996
| 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 |
