UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049763 |
|---|---|
| Receipt number | R000056385 |
| Scientific Title | Prospective randomized controlled study on the effect of multiple punctures on oocytes with low oolemma extensibility during ICSI |
| Date of disclosure of the study information | 2022/12/23 |
| Last modified on | 2022/12/13 15:56:56 |
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Basic information
Public title
Study to reduce the oocyte degeneration rate in oocytes with low oolemma extensibility during ICSI by re-puncture the oocyte from another site.
Acronym
Study of methods to reduce the rate of oocyte degeneration after ICSI
Scientific Title
Prospective randomized controlled study on the effect of multiple punctures on oocytes with low oolemma extensibility during ICSI
Scientific Title:Acronym
Investigation of the effect of multiple punctures during ICSI
Region
| Japan |
Condition
Condition
Male infertility and failure to fertilize during in vitro fertilization
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The target patients will be randomly divided into a study group (If the oolemma extension is low when the pipette is punctured during ICSI, re-puncture from a different site) and a control group (Do not re-puncture) to compare the oocyte degeneration rate after ICSI and to clarify the therapeutic effect of re-puncture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oocyte degeneration rate after ICSI
Key secondary outcomes
Fertilization rate, blastocyst development rate, pregnancy rate, miscarriage 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
| Maneuver |
Interventions/Control_1
If the oolemma extension is low when the pipette is punctured during ICSI, re-puncture from a different site.
Interventions/Control_2
Perform ICSI without re-puncture.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with male infertility (oligospermia, teratozoospermia) or previous in vitro fertilization failure who are candidates for ICSI.
Patients who have given written consent to participate in this study.
Key exclusion criteria
Patients who are eligible for TESE or PESA.
Patients with low fertilization rate by previous ICSI, or patients with severe oligozoospermia or teratozoospermia, who are indicated for oocyte activation.
Patients who cannot give written consent to participate in this study.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tomio |
| Middle name | |
| Last name | Sawada |
Organization
Sawada Women's Clinic
Division name
IVF Lab.
Zip code
464-0819
Address
Yotsuyadori 1-18-1-3F, Chikusa, Nagoya, Japan
TEL
0527883588
sawadalabolabo@gmail.com
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Sawada Women's Clinic
Division name
IVF Lab.
Zip code
464-0819
Address
Yotsuyadori 1-18-1-3F, Chikusa, Nagoya, Japan
TEL
0527883588
Homepage URL
shinwind@mail.goo.ne.jp
Sponsor or person
Institute
Sawada Women's Clinic
Institute
Department
Personal name
Funding Source
Organization
Sawada Women's Clinic
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
Institutional Review Board of Sawada Women's Clinic
Address
Yotsuyadori 1-18-1-3F, Chikusa, Nagoya, Japan
Tel
0527883588
sawadalabolabo@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
さわだウィメンズクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2022 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056385
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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