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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034482
Receipt No. 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

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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
Obsterics 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
Email 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
Email mizumoto@kuramoto.or.jp

Sponsor
Institute Kuramoto Women's Clinic
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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