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Is piezo-ICSI (intracytoplasmic sperm injection) a viable alternative for patients with previous poor fertilisation results? A prospective audit.

Assessing the efficacy of piezo-ICSI in patients with previous higher than expected degeneration rates or poor fertilisation outcomes. A prospective audit.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000952640
Enrollment
259
Registered
2023-09-04
Start date
2023-09-01
Completion date
2024-08-05
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Assessing whether applying a different technology to access the inside of the oocyte is beneficial for patients with previous poor fertilisation or high number of degenerate oocytes after using conventional ICSI. Use of piezo-ICSI will be determined by the IVF specialist after consultation with the patient. Monitoring of fertilization rates, utilisation rates and pregnancy / birth rates will be assessed.

Interventions

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 under

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.

Sponsors

Newlife IVF
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Exclusion criteria

Donor oocytes

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026