UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation the effect of group culture in WOW dishes of human embryos on embryo development
Title of the study (Brief title)	Effect of group culture in WOW dishes of human embryos on embryo development
Region	Japan

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

Objectives
Narrative objectives1	In bovine, less than 10% of the embryos developed to the blastocyst stage when embryos are cultured individually, however when the embryos are cultured in groups, 25-35% of the embryos developed to the blastocysts. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of growth factors, which are secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Using Veeck criteria for classification for cleaved embryos on day-3 and Gardner criteria for classification for blastocysts on day-5, 6 and 7, we compare the rates of the blastocyst development and good quality blastocyst development between WOW group and control group.
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	Device,equipment
Interventions/Control_1	WOW dish culture(group culture)
Interventions/Control_2	Individual culture
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	43 years-old >=
Gender	Female
Key inclusion criteria	Patients whose embryos were fertilized by Conventional IVF/ICSI Patients who had at least 3 fertilized oocytes (2PN) Patients whose whole 2PN embryos were cultured to the blastocyst stage
Key exclusion criteria	Patients who were pointed out that there were an abnormality in the chromosome analysis. Patients who had severely male factor and had to use testicular, epididymis and frozen sperm. Patients who had a severe disease of internal organ. Patients who were decided to be unsuitable for this study by doctors and researchers.
Target sample size	300

Research contact person
Name of lead principal investigator	Tomonori Ishikawa
Organization	Tokyo Medical and Dental University
Division name	Comprehensive Reproductive Medicine
Address	1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL	03-5803-5322
Email	t.ishikawa.crm@tmd.ac.jp

Public contact
Name of contact person	Tomonori Ishikawa
Organization	Tokyo Medical and Dental University
Division name	Comprehensive Reproductive Medicine
Address	1-5-45 Yushima, Bunkyo-Ku, Tokyo
TEL	03-5803-5322
Homepage URL
Email	t.ishikawa.crm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Dai Nipponn Printing Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 04 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 30 Day
Anticipated trial start date	2017 Year 02 Month 20 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024996