UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062866 |
|---|---|
| Receipt number | R000071945 |
| Scientific Title | Prospective comparative study of clinical outcomes of assisted sperm fusion insemination (ASFI) and piezo-assisted intracytoplasmic sperm injection (PIEZO-ICSI) |
| Date of disclosure of the study information | 2026/09/10 |
| Last modified on | 2026/09/10 07:09:46 |
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Basic information
Public title
A study comparing ASFI, a fertilization method designed to avoid needle penetration of the oocyte membrane, with standard PIEZO-ICSI
Acronym
ASFI versus PIEZO-ICSI Study
Scientific Title
Prospective comparative study of clinical outcomes of assisted sperm fusion insemination (ASFI) and piezo-assisted intracytoplasmic sperm injection (PIEZO-ICSI)
Scientific Title:Acronym
ASFI-PIEZO Study
Region
| Japan |
Condition
Condition
Infertility in patients scheduled to undergo intracytoplasmic sperm injection (ICSI) as part of assisted reproductive technology
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to prospectively compare assisted sperm fusion insemination (ASFI) with PIEZO-ICSI in patients scheduled for ICSI, and to comprehensively evaluate fertilization outcomes, embryo development, PGT-A outcomes in patients undergoing PGT-A, and clinical outcomes after embryo transfer. The study will also evaluate the clinical feasibility of ASFI and factors associated with inability to perform ASFI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Euploid embryo rate among PGT-A-informative embryos, assessed when PGT-A results become available and defined as the number of euploid embryos divided by the total number of euploid, aneuploid, and mosaic embryos. Embryos with no conclusive PGT-A result will be excluded from the denominator and evaluated separately as the no-result rate.
Key secondary outcomes
Normal fertilization rate; 0PN, 1PN, and 3PN rates; oocyte degeneration rate; total fertilization failure rate; feasibility and failure rate of ASFI and conversion rate to PIEZO-ICSI; cleavage rate; Day-3 good-quality embryo rate; blastocyst formation rate; good-quality blastocyst rate; biopsy-eligible blastocyst rate; usable embryo yield per mature oocyte and per retrieval cycle; aneuploid, mosaic, and PGT-A no-result rates; euploid embryo yield; implantation, clinical pregnancy, ongoing pregnancy, miscarriage, and live birth rates; and perinatal outcomes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
The first month after ethics approval will be designated as an ASFI period, followed by a PIEZO-ICSI period, with the two periods alternating every month thereafter. During ASFI periods, ASFI will be performed when mature oocytes, an immature or degenerated oocyte usable for obtaining zona-bound sperm, sufficient motile sperm, and zona-bound motile sperm are available. Motile sperm bound to the zona pellucida after co-incubation with an immature or degenerated oocyte will be recovered, introduced into the perivitelline space of a mature oocyte, and pressed against the oolemma to facilitate sperm-oocyte adhesion and membrane fusion. If ASFI cannot be performed, PIEZO-ICSI will be performed on the same day and the reason for non-performance will be recorded.
Interventions/Control_2
During PIEZO-ICSI periods, patients will undergo the standard PIEZO-ICSI procedure routinely used at the participating institutions. Subsequent embryo culture, cryopreservation, PGT-A when clinically indicated, and embryo transfer will be performed according to routine clinical practice.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Adult patients scheduled for oocyte retrieval and intracytoplasmic sperm injection (ICSI) at a participating institution.
2. Retrieval cycles using ejaculated sperm.
3. Patients who understand the study and provide consent using a method approved by the ethics committee.
4. Patients considered eligible for study participation by the investigators.
Key exclusion criteria
1. Cycles using surgically retrieved sperm, including testicular sperm.
2. Cases in which an adequate number of motile sperm required for ASFI clearly cannot be obtained.
3. Patients unable to understand the study or provide voluntary informed consent.
4. Patients considered unsuitable for study participation by the investigators.
In ASFI periods, absence of an immature/degenerated oocyte or failure to obtain zona-bound sperm after enrollment will be recorded as a reason for inability to perform ASFI rather than as a pre-enrollment exclusion, subject to consistency with the approved protocol.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Hatakeyama |
Organization
Sugiyama Clinic
Division name
Laboratory
Zip code
160-0023
Address
1-19-6, Nishi-Shinjuku, Shinjuku, Tokyo
TEL
03-5381-3000
s.hatakeyama@sugiyama.clinic
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Hatakeyama |
Organization
Sugiyama Clinic
Division name
Laboratory
Zip code
160-0023
Address
1-19-6, Nishi-Shinjuku, Shinjuku, Tokyo
TEL
03-5381-3000
Homepage URL
s.hatakeyama@sugiyama.clinic
Sponsor or person
Institute
Sugiyama Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Sugiyama Obstetrics and Gynecology
Address
1-19-6, Nishi-Shinjuku, Shinjuku, Tokyo
Tel
03-5381-3000
kanda@sugiyama.clinic
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
| 2026 | Year | 09 | Month | 10 | 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
| 2026 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071945
