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Trial registered on ANZCTR


Registration number
ACTRN12620000407998
Ethics application status
Approved
Date submitted
12/02/2020
Date registered
26/03/2020
Date last updated
18/09/2023
Date data sharing statement initially provided
26/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can an alternative type of intracytoplasmic sperm injection (ICSI)
improve fertilisation?
Scientific title
Effect of piezo-assisted intracytoplasmic sperm injection (PIEZO ICSI) upon egg fertilisation rates.
Secondary ID [1] 300534 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 316241 0
Condition category
Condition code
Reproductive Health and Childbirth 314528 314528 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PIEZO ICSI is an alternative ICSI method that utilises ultra-fast drilling coupled with a blunt-ended capillary to drill through the eggs membranes, without forced penetration. It is therefore, thought to be a more ‘gentle approach’ than conventional ICSI. No additional requirements outside of the patients standard assisted reproductive technology treatment will be required by participants. The intervention is administered ex-vivo (in the embryology laboratory) by the embryologist performing the insemination of sperm and eggs. Embryologist will monitor the development of the embryos through specific timed observations to ensure normal embryo growth following PIEZO ICSI.
Intervention code [1] 316834 0
Treatment: Devices
Comparator / control treatment
Conventional ICSI involves the use of a beveled spiked pipette to manually penetrate the egg’s plasma membrane with aspiration of the egg’s cytoplasm to activate the egg prior to injection of previously immobilised sperm.
Control group
Active

Outcomes
Primary outcome [1] 322853 0
Fertilization rate.
Outcome assessed: Laboratory analysis for the presence of 2 pronuclear embryo under microscopic observations.
Timepoint [1] 322853 0
14-16 h post ICSI.
Secondary outcome [1] 380030 0
Egg (oocyte) degeneration rate.
Outcome assessed: Laboratory analysis for lysis rates of eggs under microscopic observations.
Timepoint [1] 380030 0
Up to 1 hr post ICSI.
Secondary outcome [2] 380031 0
Embryo development
Outcome assessed: Laboratory analysis for on time embryo development under microscopic observations.
Timepoint [2] 380031 0
Day 3, 4 and day 5 embryo developmental scoring.
Secondary outcome [3] 380032 0
Embryo utilisation.
Outcome assessed: Assessment of medical records from the embryology laboratory to determine the number of embryos frozen/transferred during current treatment cycle.
Timepoint [3] 380032 0
1 week post ICSI insemination.

Eligibility
Key inclusion criteria
1. Any patient for whom ICSI is the clinical management instruction will be eligible where the semen collection method is ejaculation.

2. Patients with equal to or greater than 6 mature eggs for injection post egg retrieval.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cycles involving frozen or surgical retrieved sperm.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sibling split model.
The number of eggs collected form the patient will be assessed for suitability for injection. If the patient has greater than or equal to 6 mature eggs for injection, their eggs will be split into two groups- conventional ICSI and PIEZO ICSI. In patients where odds numbers of eggs are collected, the larger numerical value after splitting into the two groups will always be inseminated by conventional ICSI. Eggs will be randomly assigned to each treatment arm based on the random order they are denuded. If a patient has less than 6 mature eggs for injection they will be unable to partake in the trial as this is insufficient number of eggs to draw adequate conclusions. All of their eggs will instead be inseminated via conventional ICSI.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All categorical outcomes (i.e. fertilisation rate) will be analysed by a binomial regression, with patient and treatment group added as a fixed factor. Continuous data (i.e. embryo utilization) will be analysed by a paired samples T-test. The sibling split design allows for both across group (Piezo vs conventional ICSI) and within patient comparisons for stronger statistical outcomes.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Primary outcome reached significance.
Date of first participant enrolment
Anticipated
Actual
2/03/2020
Date of last participant enrolment
Anticipated
29/12/2023
Actual
31/08/2021
Date of last data collection
Anticipated
12/08/2023
Actual
Sample size
Target
225
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 15871 0
Monash IVF - Clayton - Clayton
Recruitment postcode(s) [1] 29320 0
3168 - Clayton
Recruitment postcode(s) [2] 29321 0
4215 - Southport
Recruitment postcode(s) [3] 29322 0
4066 - Auchenflower
Recruitment postcode(s) [4] 29323 0
2151 - North Parramatta
Recruitment postcode(s) [5] 35362 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 304946 0
Commercial sector/Industry
Name [1] 304946 0
Monash IVF Group Limited
Country [1] 304946 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Monash IVF Group Limited
Address
level 1, 21-31 Goodwood Street
Richmond VIC, 3121
Australia,
Country
Australia
Secondary sponsor category [1] 305300 0
None
Name [1] 305300 0
Address [1] 305300 0
Country [1] 305300 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305357 0
Bellberry Limited
Ethics committee address [1] 305357 0
Ethics committee country [1] 305357 0
Australia
Date submitted for ethics approval [1] 305357 0
28/10/2019
Approval date [1] 305357 0
07/02/2020
Ethics approval number [1] 305357 0
2019-09-817

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

Contacts
Principal investigator
Name 100102 0
A/Prof Deirdre Zander-Fox
Address 100102 0
Monash IVF Group Lmt
level 1, 21-31 Goodwood Street
Richmond VIC, 3121
Australia,
Country 100102 0
Australia
Phone 100102 0
+61 03 9429 1629
Fax 100102 0
Email 100102 0
dzander@monashivfgroup.com
Contact person for public queries
Name 100103 0
Nicole McPherson
Address 100103 0
Repromed
180 Fullarton Road
DULWICH SA 5065
Country 100103 0
Australia
Phone 100103 0
+61 08 8333 8111
Fax 100103 0
Email 100103 0
nicole.mcpherson@repromed.com.au
Contact person for scientific queries
Name 100104 0
Nicole McPherson
Address 100104 0
Repromed,
180 Fullarton Road,
DULWICH SA 5065
Country 100104 0
Australia
Phone 100104 0
+61 08 8333 8111
Fax 100104 0
Email 100104 0
nicole.mcpherson@repromed.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be shared for meta analysis purpose.


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.