UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038951 |
|---|---|
| Receipt number | R000044418 |
| Scientific Title | Embryo respiration to evaluate the embryo quality and viability and its clinical outcome |
| Date of disclosure of the study information | 2019/12/24 |
| Last modified on | 2019/12/22 18:10:39 |
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Basic information
Public title
Embryo respiration to evaluate the embryo quality and viability and its clinical outcome
Acronym
Embryo respiration to evaluate the embryo quality and viability and its clinical outcome
Scientific Title
Embryo respiration to evaluate the embryo quality and viability and its clinical outcome
Scientific Title:Acronym
Embryo respiration to evaluate the embryo quality and viability and its clinical outcome
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether embryo respiration reflect the quality and viability of the embryo or not.in clinical use.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pregnancy rate, Implantation rate, Clinical pregnancy rate, Ongoing pregnancy rate, Abortion rate, Preterm labor rate, Sex, height, body weight of newborn.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
24hours and 3 days after insemination,
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Age: under 45 years old
AFC: 4 or more, FSH: less than 10, AMH: 1 or more
Fertilized embryo: 4 or more
Without uterine factor, hydrosalpinx or pelvic endometriosis
Key exclusion criteria
Any hereditary disease
Ovarian or tubal infertility
Uterine infertility
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Fukui |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6481
at-fukui@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Fukui |
Organization
Hyogo College of Medicine
Division name
Obstetrics and Gynecology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6481
Homepage URL
at-fukui@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
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
IRB, Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.ac.jp
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
| 2019 | Year | 12 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044418
