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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020910
Receipt No. 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

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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
Obsterics 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
Email 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
Email murakami@kuramoto.or.jp

Sponsor
Institute Takeshi Kuramoto
Institute
Department

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


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