UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020910 |
|---|---|
| Receipt number | R000024126 |
| Scientific Title | Effect of embryo culture media used for ART on clinical outcomes: a randomized study |
| Date of disclosure of the study information | 2016/02/06 |
| Last modified on | 2016/02/06 17:30:00 |
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Basic information
Public title
Effect of embryo culture media used for ART on clinical outcomes: a randomized study
Acronym
Effect of embryo culture media on ART outcomes
Scientific Title
Effect of embryo culture media used for ART on clinical outcomes: a randomized study
Scientific Title:Acronym
Effect of embryo culture media on ART outcomes
Region
| Japan |
Condition
Condition
Patients receiving ART treatment at our clinic (first cycle)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of embryo culture media used for ART on clinical outcome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Good quality embryo rates by day 6 and ongoing pregnancy rates after 1 month or later of ET
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Embryo culture in G1/G2 media for 1 to 6 days
Interventions/Control_2
Embryo culture in Global Total media for 1 to 6 days
Interventions/Control_3
Embryo culture in Oligio media for 1 to 6 days
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
Male and Female
Key inclusion criteria
Patients with 1st IVF treatment cycle
Key exclusion criteria
No oocyte retrieval
Severe male factor infertility
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Kumamoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka
TEL
092-482-5558
murakami@kuramoto.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Kumamoto Women's Clinic
Division name
Research Laboratory
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka
TEL
092-482-5558
Homepage URL
murakami@kuramoto.or.jp
Sponsor or person
Institute
Takeshi Kuramoto
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Women's Clinic
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 | 02 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
| 2016 | Year | 02 | Month | 06 | Day |
Last modified on
| 2016 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024126
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
