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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034495
Receipt No. R000039117
Scientific Title Prospective randomized single center study on sibling fertilized oocytes comparing a single step culture media system with antioxidants (Gx-TL) versus a one-drop sequential culture media system with antioxidants (Gx-1, Gx-ODS)
Date of disclosure of the study information 2018/10/17
Last modified on 2018/10/15

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Basic information
Public title Prospective randomized single center study on sibling fertilized oocytes comparing a single step culture media system with antioxidants (Gx-TL) versus a one-drop sequential culture media system with antioxidants (Gx-1, Gx-ODS)
Acronym Culture in single step media versus one drop sequential culture media
Scientific Title Prospective randomized single center study on sibling fertilized oocytes comparing a single step culture media system with antioxidants (Gx-TL) versus a one-drop sequential culture media system with antioxidants (Gx-1, Gx-ODS)
Scientific Title:Acronym Culture in single step media versus one drop sequential culture media
Region
Japan

Condition
Condition Infertility
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary objective of this investigation is to assess blastocyst development comparing a single step culture media Gx-TL with the investigational devices Gx-1 and Gx-ODS.
Basic objectives2 Others
Basic objectives -Others Secondary objectives are to compare other developmental characteristics of embryos at different points of development by either using classic morphological assessment or by using time-lapse technology as well as outcome after embryo replacement.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint of the investigation is blastocyst formation on day 5 per allocated normally fertilized oocyte.
Key secondary outcomes Secondary endpoints are:
- Embryo development day 3
- Embryo quality day 3
- Embryo development day 5
- Embryo quality day 5
- Embryo development day 6
- Embryo quality day 6
- Total blastocyst formation (day 5 and day 6)
- Utilization rate (embryos available for replacement and cryopreservation)
- Clinical pregnancy rate
- Implantation 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 One-drop sequential culture media system
Interventions/Control_2 single step culture media system
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
50 years-old >=
Gender Female
Key inclusion criteria Women coming for fertility treatment presenting with more than 6 normally fertilized oocytes at the time of fertilization assessment except for the exclusion criteria listed below.
Having signed the study-specific consent form at the time of oocyte retrieval.
Key exclusion criteria Surgically retrieved sperm cells.
more than 30 normally fertilized oocytes.
Normal fertilization rate less than 40 percent.
Less than 6 fertilized oocytes on day 1.
Split IVF.
Target sample size 128

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Kyono
Organization Kyono ART Clinic
Division name President
Zip code
Address 1-1-1 3F, Honcho Aobaku,Sendai, Miyagi 980 0014, JAPAN
TEL 022-722-5991
Email rec-sec@ivf-kyono.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuya Aono
Organization Kyono ART Clinic
Division name Labolatory
Zip code
Address 1-1-1 3F, Honcho Aobaku,Sendai, Miyagi 980 0014, JAPAN
TEL 022-722-5991
Homepage URL
Email aono@ivf-kyono.or.jp

Sponsor
Institute Vitrolife Sweden AB
Institute
Department

Funding Source
Organization Self funding
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 17 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 17 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 15 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039117

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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