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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000044399
Receipt No. 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

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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
Obsterics 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
Email 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
Email masato.kobanawa@gmail.com

Sponsor
Institute Kobanawa Clinic
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050717

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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