UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034482 |
|---|---|
| Receipt number | R000039320 |
| Scientific Title | Examination of the efficiency of IVF medium with antioxidants. |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2018/10/22 18:21:35 |
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Basic information
Public title
Examination of the efficiency of IVF medium with antioxidants.
Acronym
Examination of the efficiency of IVF medium with antioxidants.
Scientific Title
Examination of the efficiency of IVF medium with antioxidants.
Scientific Title:Acronym
Examination of the efficiency of IVF medium with antioxidants.
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficiency of culture system with antioxidants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
developmental ability in vitro
Key secondary outcomes
fertilization rate, chemically pregnancy rate,clinical pregnancy rate.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Oocytes are divided to medium with antioxidants
Interventions/Control_2
Oocytes are divided to medium without antioxidants
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ART patients, more than 8 oocytes, less than 33 oocytes, patients hope blastcyst culture, obtain informed consent.
Key exclusion criteria
Previous participation in study, TESE/MESA patients, less than 8 oocytes, more than 33 oocytes, IVF and ICSI split cycle
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigetoshi Mizumoto |
Organization
Kuramoto Women's Clinic
Division name
Division of embryo culture
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL
0924825558
mizumoto@kuramoto.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetoshi Mizumoto |
Organization
Kuramoto Women's Clinic
Division name
Division of embryo culture
Zip code
Address
1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL
0924825558
Homepage URL
mizumoto@kuramoto.or.jp
Sponsor or person
Institute
Kuramoto Women's 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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2018 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 05 | 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
| 2018 | Year | 10 | Month | 13 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039320
| 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 |
