UMIN-CTR Clinical Trial

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