UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048367 |
|---|---|
| Receipt number | R000055114 |
| Scientific Title | Identification of the optimal puncture position by a real time image analysis can reduce oocyte degeneration in Piezo intracytoplasmic sperm injection |
| Date of disclosure of the study information | 2022/07/28 |
| Last modified on | 2024/01/27 18:33:59 |
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Basic information
Public title
Clinical Usefulness of an image Analysis system called ICSI POSITION DETETOR (IPD) for Oocytes with Unintended Membrane Rupture during ICSI.
Acronym
Clinical Usefulness of an image Analysis system
Scientific Title
Identification of the optimal puncture position by a real time image analysis can reduce oocyte degeneration in Piezo intracytoplasmic sperm injection
Scientific Title:Acronym
Optimal puncture position of Piezo ICSI
Region
| Japan |
Condition
Condition
Oocyte degeneration
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate whether the ICSI POSITION DETECTOR (IPD) by image analysis, which can identify the oolemma where rupture is likely to occur, is clinically useful for reducing unintentional membrane rupture (UMR) and oocyte degeneration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of unintentional membrane rupture, degeneration of the oocytes, and embryonic development.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
One of the problems during intracytoplasmic sperm injection (ICSI) procedure is unintentional membrane rupture (UMR) which often predisposes to subsequent oocyte degeneration. We reported that the oolemma has specific shape patterns by image analysis using Local Binary Pattern (LBP) that can determine the location where rupture is likely or unlikely to occur. Using LBP, we have developed the ICSI Position Detector (IPD). The aim of this study was to demonstrate whether the IPD is useful to identify the optimal puncture location to prevent UMR on ICSI procedure.
Interventions/Control_2
ICSI was performed not using the IPD.
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
| 25 | years-old | <= |
Age-upper limit
| 46 | years-old | > |
Gender
Female
Key inclusion criteria
Consenting infertile patients with two or more mature oocytes retrieved
Key exclusion criteria
impairment of fertilization cases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TAKASHI |
| Middle name | |
| Last name | MORIMOTO |
Organization
Reproduction Clinic Tokyo
Division name
Culture Department
Zip code
105-7103
Address
3F,Shiodome City Center, 1-5-2, Higashishimbashi, Minato, Tokyo
TEL
03-6228-5351
tmorimoto@reptokyo.jp
Public contact
Name of contact person
| 1st name | TOMOHIRO |
| Middle name | |
| Last name | MAEKAWA |
Organization
Reproduction Clinic Tokyo
Division name
Culture Department
Zip code
105-7103
Address
3F,Shiodome City Center, 1-5-2, Higashishimbashi, Minato, Tokyo
TEL
03-6228-5351
Homepage URL
tmaekawa@reptokyo.jp
Sponsor or person
Institute
Reproduction Clinic Tokyo
Institute
Department
Personal name
Funding Source
Organization
Nothing special
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Tokyo
Address
3F,Shiodome City Center, 1-5-2, Higashishimbashi, Minato, Tokyo
Tel
03-6228-5351
smizuta@reposaka.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
| 2022 | Year | 07 | Month | 28 | 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
113
Results
The rates of UMR (7.0% vs. 12.9%, P = 0.004) and degeneration (2.4% vs. 6.1%, P<0.01 = 0.008) were significantly lower in the IPD group than in the non-IPD group. However, no significant differences were observed in the rates of fertilization (2PN, 83.8% vs. 78.9%), blastocyst formation (48.5% vs. 48.8%), or good-quality blastocysts (22.5% vs. 20.5%).
Results date posted
| 2024 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between January 2020 and October 2022, this study included 917 oocytes inseminated with Piezo ICSI from 113 consenting infertile patients with two or more mature oocytes retrieved, and moving images were recorded during Piezo-ICSI using IPD.
Participant flow
In the sibling study, oocytes (n=917) were randomly divided into two groups with or without IPD. If the number of mature oocytes recovered was uneven, they were allocated according to whether the patient unique ID number was even or odd. The remaining oocyte was allocated to the IPD group when the patient ID was even, in the case of an odd number, it was allocated to the non-IPD group.
In the IPD group, IPD was applied to 458 mature oocytes and Piezo-ICSI was performed at a position identified by IPD as having a low risk of UMR (IPD group). The remaining 459 oocytes were inseminated by Piezo-ICSI without IPD (non-IPD group). Piezo-ICSI with IPD was performed first, followed by the procedure without IPD.
Adverse events
Outcome measures
Culture results with or without IPD were compared in terms of the rates of UMR, degeneration, fertilization, blastocyst formation, and good-quality blastocysts.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 05 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055114
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