Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000352404
Ethics application status
Approved
Date submitted
3/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a 3D Printed Device to facilitate Intracytoplasmic Sperm Injection (ICSI): Achieving Comparable Fertilisation Rates to Conventional Methods
Scientific title
Use of a 3D printed microICSI device to facilitate intracytoplasmic sperm injection (ICSI) insemination of human oocytes: A prospective sibling oocyte study (non-inferiority).
Secondary ID [1] 313850 0
microICSI-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 336509 0
Condition category
Condition code
Reproductive Health and Childbirth 333015 333015 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This clinical investigation aims to evaluate the performance and safety of the microICSI device, an investigational product designed to improve the specialised in vitro fertilization (IVF) process of intracytoplasmic sperm injection (ICSI) by reducing physical trauma to oocytes during insemination.

The microICSI device is comprised of a square dish base with angled corners, an insert and a lid. The dish size is 65.00 mm x 65.00 mm.

The microICSI device with be used by experienced embryologists in a clinical setting. Full product training will be conducted prior to use.

The participants will under pre-treatment and enrolment procedures, ensuring that inclusion and exclusion criteria and fully met prior to signed consent. Fresh or frozen sperm will be collected, and a minimum of six oocytes. Half the oocytes will be administered for microICSI, with the other half being used for cICSI.

The clinical monitor will ensure adherence to all aspects of the trial, via clinical monitoring visits and validation of data in the EDC.

If multiple oocytes progress to blastocyst stage, the best quality blastocyst will be selected for embryo transfer, as per standard best practice.
Intervention code [1] 330434 0
Treatment: Devices
Comparator / control treatment
Participating women will have their oocytes randomly assigned with half of the oocytes to be inseminated using conventional ICSI (cICSI) and the other half with microICSI for insemination.

Conventional ICSI (Intracytoplasmic Sperm Injection) is a technique used in assisted reproductive technology (ART), specifically in in vitro fertilization (IVF). In conventional ICSI, a single sperm is directly injected into an egg's cytoplasm using a fine needle. This method is primarily used when there are male fertility issues, such as low sperm count, poor sperm motility, or abnormal sperm morphology.

The process generally involves the following steps:

Ovarian Stimulation: The woman undergoes ovarian stimulation with hormones to produce multiple eggs.

Egg Retrieval: Eggs are retrieved from the ovaries.

Sperm Selection: A single sperm is selected, often using a microscope to choose the healthiest-looking sperm.

Injection: The selected sperm is injected directly into the egg’s cytoplasm using a specialized needle.

Fertilization and Embryo Culture: After fertilization, the embryos are cultured for a few days before being transferred into the woman's uterus.

This method allows fertilization to occur even when sperm quality is significantly compromised, offering couples with male infertility a higher chance of pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 340555 0
The primary endpoint for this study is the rate of fertilization.
Timepoint [1] 340555 0
16-18 hours after insemination
Secondary outcome [1] 444461 0
Clinical pregnancy
Timepoint [1] 444461 0
6-8 weeks post embryo transfer

Eligibility
Key inclusion criteria
Patients intending to undergo ICSI where there are:

- no medical contraindications to perform the treatment.

- 6 or more mature oocytes at the time of cumulus cell removal.

- Signed informed consent form prior to any study-related procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Individuals under the age of 18 or age of legal consent

<6 mature oocytes at the time of cumulus removal

- Fertility preservation patients

- Previous participation in the study

- Previous failed fertilization with ICSI

- Patients with surrogates/gestational carriers

- Artificial oocyte activation

- Frozen oocytes

- Testicular biopsy

- IMSI

- Zymot

- Zona binding

- PGT-A, PGT-M or PGT-SR

- MI to MII oocytes (must be MII at 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)
Centralised randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
83
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 318316 0
Commercial sector/Industry
Name [1] 318316 0
Fertilis Pty Ltd
Country [1] 318316 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fertilis Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320707 0
None
Name [1] 320707 0
Address [1] 320707 0
Country [1] 320707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316951 0
Melbourne IVF
Ethics committee address [1] 316951 0
Ethics committee country [1] 316951 0
Australia
Date submitted for ethics approval [1] 316951 0
17/02/2025
Approval date [1] 316951 0
07/04/2025
Ethics approval number [1] 316951 0

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

Contacts
Principal investigator
Name 139538 0
Prof David Gardner
Address 139538 0
Melbourne IVF, 344 Victoria Parade, East Melbourne VIC 3002
Country 139538 0
Australia
Phone 139538 0
+61 424176562
Fax 139538 0
Email 139538 0
[email protected]
Contact person for public queries
Name 139539 0
David Gardner
Address 139539 0
Melbourne IVF, 344 Victoria Parade, East Melbourne VIC 3002
Country 139539 0
Australia
Phone 139539 0
+61 424176562
Fax 139539 0
Email 139539 0
[email protected]
Contact person for scientific queries
Name 139540 0
David Gardner
Address 139540 0
Melbourne IVF, 344 Victoria Parade, East Melbourne VIC 3002
Country 139540 0
Australia
Phone 139540 0
+61 424176562
Fax 139540 0
Email 139540 0
[email protected]

Data sharing statement
Will the study consider sharing 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.