UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050410 |
|---|---|
| Receipt number | R000057397 |
| Scientific Title | Investigation of methods to prevent oocyte degeneration caused by abnormal rupture in Piezo-assisted intracytoplasmic sperm injection (Piezo-ICSI) |
| Date of disclosure of the study information | 2023/02/22 |
| Last modified on | 2023/02/22 11:43:16 |
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Basic information
Public title
Investigation of methods to prevent oocyte degeneration in minimally invasive ICSI
Acronym
Investigation of methods to prevent oocyte degeneration in Piezo-ICSI
Scientific Title
Investigation of methods to prevent oocyte degeneration caused by abnormal rupture in Piezo-assisted intracytoplasmic sperm injection (Piezo-ICSI)
Scientific Title:Acronym
Investigation of methods to prevent oocyte degeneration caused by abnormal rupture in Piezo-ICSI.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether it is possible to prevent oolemma lysis after Piezo-ICSI caused by abnormal membrane rupture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Normal fertilization rate, degeneration rate, proportion of high-quality embryos on day 3, blastocyst formation, and morphologically high-quality blastocysts
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inseminated oocytes were classified into the following two groups: normal rupture and abnormal rupture.
Interventions/Control_2
Among the abnormal rupture groups, the normal fertilization and degeneration rates were compared between the high-stretched (ruptured at more than 50% during oocyte membrane stretching) and low-stretched (less than 50% position) oocytes.
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
| 24 | years-old | <= |
Age-upper limit
| 48 | years-old | >= |
Gender
Female
Key inclusion criteria
1) When semen findings are poor.
2) When the split method is used for the first egg retrieval.
3) When semen findings are good but ICSI is essential due to insemination failure.
Key exclusion criteria
1) When IVF is performed.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Mizuno |
Organization
Kusuhara Women's Clinic
Division name
Culture department
Zip code
104-0061
Address
Ginza shippo building 6F 5-6-2 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-6274-6433
kusuhara.labo@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Mizuno |
Organization
Kusuhara Women's Clinic
Division name
Culture department
Zip code
104-0061
Address
Ginza shippo building 6F 5-6-2 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-6274-6433
Homepage URL
kusuhara.labo@gmail.com
Sponsor or person
Institute
Kusuhara Women's Clinic
Institute
Department
Personal name
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
Kusuhara Women's Clinic
Address
Ginza shippo building 6F 5-6-2 Ginza, Chuo-ku, Tokyo 104-0061, Japan
Tel
03-6274-6433
kusuhara.labo@gmail.com
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
| 2023 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
170
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
Completed
Date of protocol fixation
| 2023 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 22 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057397
