UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the efficiency of IVF medium with antioxidants.
Title of the study (Brief title)	Examination of the efficiency of IVF medium with antioxidants.
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficiency of culture system with antioxidants.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	developmental ability in vitro
Key secondary outcomes	fertilization rate, chemically pregnancy rate,clinical pregnancy 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	Oocytes are divided to medium with antioxidants
Interventions/Control_2	Oocytes are divided to medium without antioxidants
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	Not applicable
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	ART patients, more than 8 oocytes, less than 33 oocytes, patients hope blastcyst culture, obtain informed consent.
Key exclusion criteria	Previous participation in study, TESE/MESA patients, less than 8 oocytes, more than 33 oocytes, IVF and ICSI split cycle
Target sample size	128

Research contact person
Name of lead principal investigator	Shigetoshi Mizumoto
Organization	Kuramoto Women's Clinic
Division name	Division of embryo culture
Address	1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL	0924825558
Email	mizumoto@kuramoto.or.jp

Public contact
Name of contact person	Shigetoshi Mizumoto
Organization	Kuramoto Women's Clinic
Division name	Division of embryo culture
Address	1-1-19 Hakataeki-higashi, Hakata-ku, Fukuoka 812-0013, Japan
TEL	0924825558
Homepage URL
Email	mizumoto@kuramoto.or.jp

Sponsor
Institute	Kuramoto Women's Clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 08 Month 05 Day
Anticipated trial start date	2018 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 13 Day
Last modified on	2018 Year 10 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039320