UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034495 |
|---|---|
| Receipt number | 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 | 2022/04/18 09:14:32 |
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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
| Obstetrics 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
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
aono@ivf-kyono.or.jp
Sponsor or person
Institute
Vitrolife Sweden AB
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 17 | Day |
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
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
