UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044399 |
|---|---|
| Receipt number | R000050717 |
| Scientific Title | The study of Embryo culture and clinical results using Continuous Single Culture Complete NX(CSCM-NX) which is low lactate culture medium. |
| Date of disclosure of the study information | 2021/06/02 |
| Last modified on | 2021/06/01 21:20:47 |
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Basic information
Public title
Results of the in-vitro fertilization under lactate little environment
Acronym
A study of low lactate culture medium
Scientific Title
The study of Embryo culture and clinical results using Continuous Single Culture Complete NX(CSCM-NX) which is low lactate culture medium.
Scientific Title:Acronym
A study of low lactate culture medium
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the difference in results of the conventional embryo culture medium and low lactic acid embryo culture medium.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blastocyst rate,good blastocyst rate,clinical pregnancy rate
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The embryo which was cultured in the conventional culture medium from January, 2020 to September, 2020
Interventions/Control_2
The embryo which was cultured in the low lactate culture medium from January, 2020 to September, 2020
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
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
The fertilized embryo of 20-44 years old
Key exclusion criteria
The non fertilized embryo
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kobanawa |
Organization
Kobanawa Clinic
Division name
Gynecology
Zip code
311-3435
Address
169-3 Tagiya,Omitama-shi,Ibaraki,Japan
TEL
0299-58-3185
masato.kobanawa@gmail.com
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Kobanawa |
Organization
Kobanawa Clinic
Division name
Gynecology
Zip code
311-3435
Address
169-3 Tagiya,Omitama-shi,Ibaraki,Japan
TEL
0299-58-3185
Homepage URL
masato.kobanawa@gmail.com
Sponsor or person
Institute
Kobanawa Clinic
Institute
Department
Personal name
Funding Source
Organization
Kobanawa Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Kobanawa Clinic
Address
169-3 Tagiya,Omitama-shi,Ibaraki,Japan
Tel
0299-58-3185
kobanawa0416@gmail.com
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
| 2021 | Year | 06 | Month | 02 | 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
100
Results
The result did not accept the significant difference to a blastocyst incidence, a good blastocyst arrival rate, fertility index, and I was not able to show the superiority of CSCM-NX which was the culture fluid which reduced lactic acid, but the results that were equal to CSCM were provided.
(It was disclosed at the 65th Japan reproduction medical society arts and sciences lecture, general meeting)
Results date posted
| 2021 | Year | 06 | Month | 01 | Day |
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
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2021 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050717
| 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 |
