UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparing new vitrification media to solution currently used.
Title of the study (Brief title)	Comparing new vitrification media to solution currently used
Region	Japan

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

Objectives
Narrative objectives1	To get knowledge whether a new vitrification/warming media bring about same or better outcome compare with conventional media
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Observe the recovery condition of embryos after warming, and obtain the survival rate between the two media.
Key secondary outcomes	In addition, obtain the pregnancy rate after embryo transfer.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Vitrify, warm and transfer embryos using the new vitrification/warming media by December, 2018
Interventions/Control_2	Vitrify, warm and transfer embryos using the conventional vitrification/warming media by December, 2018
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	Not applicable
Gender	Female
Key inclusion criteria	Use embryos for this study only when embryo development and morphologic evaluation achieve our standard which embryos can be vitrified.
Key exclusion criteria	When the growth of the embryos stop or when a morphologic evaluation does not achieve our standard that can enforce embryo vitrification, it is excluded from this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Takafumi Utsunomiya
Organization	St. Luke Clinic
Division name	Doctor
Address	1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan
TEL	097-547-1234
Email	st-luke@oct-net.ne.jp

Public contact
Name of contact person	Yoko Kumasako
Organization	St.Luke clinic
Division name	Laboratory
Address	1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan
TEL	097-547-1234
Homepage URL
Email	ykumasa@st-luke.ne.jp

Sponsor
Institute	St.Luke 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	セント・ルカ産婦人科（大分県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
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 12 Month 07 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028966