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Trial registered on ANZCTR


Registration number
ACTRN12623000952640
Ethics application status
Approved
Date submitted
28/04/2023
Date registered
4/09/2023
Date last updated
18/08/2024
Date data sharing statement initially provided
4/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is piezo-ICSI (intracytoplasmic sperm injection) a viable alternative for patients with previous poor fertilisation results? A prospective audit.
Scientific title
Assessing the efficacy of piezo-ICSI in patients with previous higher than expected degeneration rates or poor fertilisation outcomes. A prospective audit.
Secondary ID [1] 309293 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Health 328990 0
Condition category
Condition code
Reproductive Health and Childbirth 325975 325975 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Conventional ICSI (intracytoplasmic sperm injection) is generally performed using an injection pipette which pierces the zona pellucida and the oolemma of the oocyte which may cause damage to the fragile oocyte. Piezo is a different method of perforating the zona pellucida and the oolemma, using ultra rapid submicron forward movement delivered by a flat tipped pipette. Published studies have shown a reduced degeneration rate and increased fertilisation rate with piezo-ICSI. Patients will undergo conventional ICSI regardless of their involvement in this study

Patient suitability/eligibility for piezo-ICSI: Patients that have a higher than expected degeneration rate (>2 oocytes) or poor fertilisation outcomes (<30% normal fertilisation) on a previous conventional ICSI cycle may be offered piezo-ICSI as a method of fertilisation by their fertility specialist.

Performance of piezo-ICSI: The procedure is performed in the Newlife IVF laboratory approximately 3h after oocyte collection as per standard insemination protocol. There is no change to the patient experience as this is a laboratory based technique. Piezo-ICSI is performed in a similar fashion to conventional ICSI with minimal disruption to patients’ gametes outside of a temperature and gas controlled environment. No additional procedures or tests are required for the patient to undertake.

Monitoring: All participants undergoing conventional ICSI or piezo-ICSI cycles will be continually monitored for fertilisation rate, oocyte degeneration rate, abnormal fertilisation rates, cleavage and blastulation rate, utilisation rate and pregnancy rate, as is standard practice at Newlife IVF. The study will not involve any additional procedures or follow up outside of a conventional ICSI cycle.
Intervention code [1] 326767 0
Not applicable
Comparator / control treatment
Conventional ICSI (intracytoplasmic sperm injection) which is generally performed using an injection pipette which pierces the zona pellucida and the oolemma of the oocyte.
Control group
Active

Outcomes
Primary outcome [1] 333820 0
Fertilization: All injected oocytes will be examined for the presence of pronuclei (PN) and polar bodies (PB). Rates of normal fertilisation (2PN), oocyte degeneration and abnormal fertilisation will be assessed as a composite primary outcome.
Timepoint [1] 333820 0
At or prior to 17 hours post sperm insemination from laboratory records.
Secondary outcome [1] 418433 0
Cleavage and blastulation rate: Embryos are graded individually and notes made on their cleavage patterns and blastulation.
Timepoint [1] 418433 0
Up to 6 days post insemination from laboratory records
Secondary outcome [2] 425402 0
Utilisation rate: assessed at the conclusion of laboratory procedures to determine how many usable embryos were produced per fertilised oocyte via audit of laboratory records
Timepoint [2] 425402 0
Assessed on a weekly basis at the conclusion of laboratory procedures, 6 days post insemination. Cumulative data will be assessed at the conclusion of the study
Secondary outcome [3] 425403 0
Pregnancy rate: a pregnancy blood test is taken measuring QHCG and progesterone
Timepoint [3] 425403 0
The blood test is taken 16 days post egg retrieval day.
Secondary outcome [4] 425404 0
Fetal heart monitoring: an ultrasound assessment of fetal heart(s) is performed.
Timepoint [4] 425404 0
An ultrasound scan is performed 6 to 7 weeks post day 1 of cycle.
Secondary outcome [5] 425405 0
Miscarriage rates: assess number of patients with early pregnancy loss. Assessment carried out by a review of medical records
Timepoint [5] 425405 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [6] 425406 0
Birth: assess birth rates from clinical pregnancies. Assessment carried out by a review of medical records
Timepoint [6] 425406 0
Cumulative data will be assessed at the conclusion of the study

Eligibility
Key inclusion criteria
Participation will be open to patients deemed suitable for conventional ICSI and a history of low fertilisation (<30% normal fertilisation rate) or higher than expected oocyte degeneration. The decision to undertake piezo-ICSI is made with the fertility specialist and part of clinical care.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Donor oocytes

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Number to be recruited is 259. The number has been determined by running a sample size calculation using STATA Version 17 (Wald Test) to detect a 10% increase in fertilisation rate. The statistical significant level was set at 0.05 and 90% power.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
Actual
5/08/2024
Date of last data collection
Anticipated
Actual
5/08/2024
Sample size
Target
259
Accrual to date
Final
259
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24354 0
Epworth Eastern Ekera - Box Hill North
Recruitment postcode(s) [1] 39853 0
3128 - Box Hill
Recruitment postcode(s) [2] 39924 0
3128 - Box Hill North

Funding & Sponsors
Funding source category [1] 313113 0
Commercial sector/Industry
Name [1] 313113 0
Newlife IVF
Country [1] 313113 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Newlife IVF
Address
Suite 3, Third Floor
116–118 Thames Street,
Box Hill North, VIC 3129
Country
Australia
Secondary sponsor category [1] 314813 0
None
Name [1] 314813 0
Address [1] 314813 0
Country [1] 314813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312362 0
Bellberry Limited
Ethics committee address [1] 312362 0
Ethics committee country [1] 312362 0
Australia
Date submitted for ethics approval [1] 312362 0
Approval date [1] 312362 0
27/02/2023
Ethics approval number [1] 312362 0
2019-11-947-PRE-3

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

Contacts
Principal investigator
Name 124386 0
Dr Tiki Osianlis
Address 124386 0
Newlife IVFSuite 3, Third Floor116–118 Thames Street,Box Hill North, VIC 3129
Country 124386 0
Australia
Phone 124386 0
+61 03 8080 8933
Fax 124386 0
Email 124386 0
tiki@newlifeivf.com.au
Contact person for public queries
Name 124387 0
Fatima Figueiredo
Address 124387 0
Newlife IVFSuite 3, Third Floor116–118 Thames Street,Box Hill North, VIC 3129
Country 124387 0
Australia
Phone 124387 0
+61 03 8080 8933
Fax 124387 0
Email 124387 0
fatima@newlifeivf.com.au
Contact person for scientific queries
Name 124388 0
Fatima Figueiredo
Address 124388 0
Newlife IVFSuite 3, Third Floor116–118 Thames Street,Box Hill North, VIC 3129
Country 124388 0
Australia
Phone 124388 0
+61 03 8080 8933
Fax 124388 0
Email 124388 0
fatima@newlifeivf.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


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.