UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042766 |
|---|---|
| Receipt number | R000048805 |
| Scientific Title | Study of the usefulness of novel vitrification freezing devices for oocyte and embryos |
| Date of disclosure of the study information | 2020/12/16 |
| Last modified on | 2021/06/17 20:43:53 |
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Basic information
Public title
Study of the usefulness of novel vitrification freezing devices for oocyte and embryos
Acronym
Freezing device
Scientific Title
Study of the usefulness of novel vitrification freezing devices for oocyte and embryos
Scientific Title:Acronym
Freezing device
Region
| Japan |
Condition
Condition
Oocyte and embryos discarded in fertility treatment
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we evaluate the survival rate and development rate of embryos using the freezing devices marketed by each company with the aim of finding excellent freezing devices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Oocyte: Survival rate after freezing and thawing
Embryo: Survival rate after freeze-thaw
Key secondary outcomes
Embryo: Blastocyst arrival rate, good blastocyst rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Following informed consent sufficient to participate in this research, document agreement by the patient's free will is obtained.
2)Oocyte
immature oocytes that were discarded because the first polar body was not observed in the oocytes by the specified time on the day of egg retrieval, among the oocytes obtained from patients who egg retrieval for infertility treatment.
3)Embryo
Embryos that had been vitrified and frozen for embryo transfer but were discarded.
Key exclusion criteria
1)Patients who are judged inappropriate as research subjects by the research director or research co-investigator.
2)Oocyte
Immature oocytes in which the first polar body is not observed by the next day after being discarded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Magara |
Organization
Mie university
Division name
Center of of Advanced reproductive medicine , Mie Hospital
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie
TEL
059-232-1111
tada-m@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Magara |
Organization
Mie university
Division name
Center of of Advanced reproductive medicine , Mie Hospital
Zip code
514-8507
Address
2-174 Edobashi Tsu, Mie
TEL
059-232-1111
Homepage URL
magara-e@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie university
Institute
Department
Personal name
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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi Tsu, Mie
Tel
059-232-1111
kk-sien@mo.medic.mie-u.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
| 2020 | Year | 12 | Month | 16 | 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
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study of the usefulness of novel vitrification freezing devices for oocytes and embryos
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048805
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
