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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030904
Receipt No. R000035277
Scientific Title Comparing clinical efficacy of the media from human tubal fluid to the media currently used.
Date of disclosure of the study information 2018/01/22
Last modified on 2018/01/20

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Basic information
Public title Comparing clinical efficacy of the media from human tubal fluid to the media currently used.
Acronym Comparing clinical efficacy of the media from human tubal fluid to the media currently used.
Scientific Title Comparing clinical efficacy of the media from human tubal fluid to the media currently used.
Scientific Title:Acronym Comparing clinical efficacy of the media from human tubal fluid to the media 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 media for embryo 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 Compere the pregnancy rate following embryo transfer after using new media to using conventional media.
Key secondary outcomes Observe the condition in embryo development, and obtain the rate of efficacy embryo between the two media.

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 Culture and transfer embryos using the new media by June, 2020
Interventions/Control_2 Culture and transfer embryos using the conventional media by June, 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

Not applicable
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Use embryos for this study only when normal fertilization is obtained after in vitro fertilization.
Key exclusion criteria When none of normal embryos obtained, it is excluded from this study.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Utsunomiya
Organization St. Luke Clinic
Division name Doctor
Zip code
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
1st name
Middle name
Last name Yoko Kumasako
Organization St. Luke clinic
Division name Laboratory
Zip code
Address 1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan
TEL 097-547-1234
Homepage URL
Email ykumasa@st-luke.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)

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 セント・ルカ産婦人科(大分県)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 22 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 20 Day
Last modified on
2018 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035277

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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