UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized single center study on sibling fertilized oocytes comparing a single step culture media system with antioxidants (Gx-TL) versus a one-drop sequential culture media system with antioxidants (Gx-1, Gx-ODS)
Acronym	Culture in single step media versus one drop sequential culture media
Scientific Title	Prospective randomized single center study on sibling fertilized oocytes comparing a single step culture media system with antioxidants (Gx-TL) versus a one-drop sequential culture media system with antioxidants (Gx-1, Gx-ODS)
Scientific Title:Acronym	Culture in single step media versus one drop sequential culture media
Region	Japan

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

Objectives
Narrative objectives1	The primary objective of this investigation is to assess blastocyst development comparing a single step culture media Gx-TL with the investigational devices Gx-1 and Gx-ODS.
Basic objectives2	Others
Basic objectives -Others	Secondary objectives are to compare other developmental characteristics of embryos at different points of development by either using classic morphological assessment or by using time-lapse technology as well as outcome after embryo replacement.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint of the investigation is blastocyst formation on day 5 per allocated normally fertilized oocyte.
Key secondary outcomes	Secondary endpoints are: - Embryo development day 3 - Embryo quality day 3 - Embryo development day 5 - Embryo quality day 5 - Embryo development day 6 - Embryo quality day 6 - Total blastocyst formation (day 5 and day 6) - Utilization rate (embryos available for replacement and cryopreservation) - Clinical pregnancy rate - Implantation 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	One-drop sequential culture media system
Interventions/Control_2	single step culture media system
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	50 years-old >=
Gender	Female
Key inclusion criteria	Women coming for fertility treatment presenting with more than 6 normally fertilized oocytes at the time of fertilization assessment except for the exclusion criteria listed below. Having signed the study-specific consent form at the time of oocyte retrieval.
Key exclusion criteria	Surgically retrieved sperm cells. more than 30 normally fertilized oocytes. Normal fertilization rate less than 40 percent. Less than 6 fertilized oocytes on day 1. Split IVF.
Target sample size	128

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Kyono
Organization	Kyono ART Clinic
Division name	President
Zip code
Address	1-1-1 3F, Honcho Aobaku,Sendai, Miyagi 980 0014, JAPAN
TEL	022-722-5991
Email	rec-sec@ivf-kyono.or.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuya Aono
Organization	Kyono ART Clinic
Division name	Labolatory
Zip code
Address	1-1-1 3F, Honcho Aobaku,Sendai, Miyagi 980 0014, JAPAN
TEL	022-722-5991
Homepage URL
Email	aono@ivf-kyono.or.jp

Sponsor
Institute	Vitrolife Sweden AB
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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	Terminated
Date of protocol fixation	2018 Year 07 Month 09 Day
Date of IRB	2016 Year 09 Month 15 Day
Anticipated trial start date	2018 Year 10 Month 17 Day
Last follow-up date	2021 Year 10 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 15 Day
Last modified on	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039117