Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001194358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
10/09/2026
Date registered
Help: Date registered
24/09/2026
Date last updated
Help: Date last updated
24/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of fertilisation rate after conventional Intracytoplasmic Sperm Injection (ICSI) or PIEZO-ICSI: A sibling oocyte study in In Vitro Fertilisation (IVF) patients aged 38 and above
Scientific title
Comparison of fertilisation rate after conventional Intracytoplasmic Sperm Injection (ICSI) or PIEZO-ICSI: A sibling oocyte study in IVF patients aged 38 and above
Additional trial identifiers [1] 317427 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Infertility 342108 0
Condition category
Condition code
Reproductive Health and Childbirth 338220 338220 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Half of each patient's mature oocytes will be randomised to the treatment group, and will be injected with sperm using PIEZO-ICSI. The other half of the oocytes will be injected with conventional ICSI.
The PIEZO-ICSI method utilizes a PIEZO actuator in piercing zona pellucida of oocytes, which allows for microinjections with less physical stress being applied during the procedure. In the PIEZO-ICSI application, a PIEZO actuator is attached firmly to the microcapillary holder and a thin-walled flat-tipped, thin walled microcapillary is used instead of a conventionally spiked one. The flat tip of the micropipette is pressed gently to the zona pellucida so that the circular edge of the pipette tip makes continuous contact with the zona. The PIEZO-electric materials inside of the actuator convert electric energy into mechanical energy, thus the PIEZO-electric effect is generated (crystal deformation in response to an externally applied voltage). The extremely rapid signals propel the holder together with the microcapillary forward, producing ultra-fast sub-micron axial and lateral momentum in a precise and rapid movement that allows the opposing biological structures to be penetrated.
The timing of the PIEZO-ICSI procedure will be the same as standard treatment for ICSI, i.e. 39-41 hours after the patient takes the trigger medication, PIEZO-ICSI will be performed by a scientist trained on the procedure, in the IVF laboratory. Where possible, the same scientist will perform the conventional ICSI on the same patient, with the oocytes randomised to the control group. The procedure performed first will be randomised, and one procedure will be performed immediately after the other. It is expected that the PIEZO-ICSI procedure will require a similar time as conventional ICSI, and the duration of the procedure is dependant on the number of oocytes collected (approximately 15min to 1h). A minimum of 2 oocytes will be injected with PIEZO-ICSI for each randomised patient. Records will be kept of the trial procedures and reviewed by the researchers to assess adherence to the intervention.
Intervention code [1] 334221 0
Treatment: Devices
Description of the comparator or control
Half of each patient's oocytes will be randomised to the control group and will be injected with sperm using conventional ICSI. The timing of the conventional ICSI procedure will be the same as standard treatment, i.e. 39-41 hours after the patient takes the trigger medication, The duration of the procedure is dependant on the number of oocytes collected (approximately 15min to 1h).
Control group
Active

Outcomes
Primary outcome [1] 345587 0
Fertilisation rate (2 pronuclei (2PN)) per inseminated mature (MII) oocyte
Timepoint [1] 345587 0
16-18 hours post insemination
Secondary outcome [1] 462277 0
Oocyte degeneration rate per inseminated MII oocyte
Timepoint [1] 462277 0
16-18 hours post insemination
Secondary outcome [2] 462280 0
Day 5 Top quality blastocyst rate (Expanded AA per inseminated MII oocyte)
Timepoint [2] 462280 0
Day 5 post-insemination
Secondary outcome [3] 462281 0
Total top quality blastocyst rate (Expanded AA per inseminated MII oocyte)
Timepoint [3] 462281 0
The end of embryo culture (up to Day 7)
Secondary outcome [4] 462288 0
Embryo utilisation rate per inseminated MII oocyte
Timepoint [4] 462288 0
The end of embryo culture (up to Day 7)
Secondary outcome [5] 467785 0
Number of embryos utilised per randomised patient
Timepoint [5] 467785 0
The end of embryo culture (up to Day 7)
Secondary outcome [6] 467786 0
Clinical pregnancy rate per first embryo transfer
Timepoint [6] 467786 0
3-4 weeks after embryo transfer

Eligibility
Key inclusion criteria
Female patients or couples undergoing IVF treatment with ICSI, where the female providing oocytes is greater than or equal to 38 years old, and has 4 or more mature oocytes. Male partners or sperm donors must be over 18 years old.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Female patients <38 years old
Previous participation in the study
Donor oocytes
Patients with surrogates/gestational carriers
Artificial oocyte activation
Testicular biopsy
Sperm selection by Intracytoplasmic Morphologic Sperm Injection (IMSI)
Sperm selection by zona binding
Preimplantation genetic testing for monogenic conditions (PGT-M) or structural rearrangements (PGT-SR)
Insemination with IVF or split IVF/ICSI cycles
Cryopreserved oocytes
Split oocyte cryopreservation/ICSI cycles
Ovarian tissue graft patients
Patients with <4 mature oocytes at the time of denudation.
Oocytes that are immature at the time of denudation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used to conceal treatment allocation until after the oocytes have been randomised into two groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, blocks of 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Within-subject randomisation: sibling oocytes from the same individual will be randomised into two groups. The groups will then be randomly assigned to treatment or control using sealed opaque envelopes.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 30209 0
Melbourne IVF - Collingwood
Recruitment postcode(s) [1] 45936 0
3066 - Collingwood

Funding & Sponsors
Funding source category [1] 322004 0
Commercial sector/Industry
Name [1] 322004 0
Virtus Health
Country [1] 322004 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Melbourne IVF
Address
Country
Australia
Secondary sponsor category [1] 325080 0
None
Name [1] 325080 0
Address [1] 325080 0
Country [1] 325080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320536 0
Virtus Health HREC
Ethics committee address [1] 320536 0
Ethics committee country [1] 320536 0
Australia
Date submitted for ethics approval [1] 320536 0
15/11/2022
Approval date [1] 320536 0
01/05/2023
Ethics approval number [1] 320536 0
97/22-MIVF

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150790 0
Prof David Gardner
Address 150790 0
Melbourne IVF, 36 Wellington St, Collingwood, VIC 3066
Country 150790 0
Australia
Phone 150790 0
+61 3 9473 4441
Fax 150790 0
Email 150790 0
[email protected]
Contact person for public queries
Name 150791 0
Franca Agresta
Address 150791 0
Melbourne IVF, 36 Wellington St, Collingwood, VIC 3066
Country 150791 0
Australia
Phone 150791 0
+61 3 9473 4570
Fax 150791 0
Email 150791 0
[email protected]
Contact person for scientific queries
Name 150792 0
Rebecca Kelley
Address 150792 0
Melbourne IVF, 36 Wellington St, Collingwood, VIC 3066
Country 150792 0
Australia
Phone 150792 0
+61 3 9473 4404
Fax 150792 0
Email 150792 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Health economic analyses
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 10 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]
david,[email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.