None listed
Conditions
Brief summary
The purpose of this study is to investigate the efficacy of piezo ICSI as an alternative to the traditional ICSI technique for human oocyte insemination and to assess if fertilisation rates can be improved. We will be able to assess if this alternative technique which uses a Piezo machine will decrease oocyte degeneration rates as well as improving embryo quality and pregnancy rates. A previous study demonstrated that a significantly higher survival rate post injection was seen for oocytes being injected with piezo rather than conventional ICSI (90% vs 95%) and were higher still using the ultra fine piezo pipette (99%). Fertilisation rates were also higher with piezo ICSI and higher still with ultra fine micropipette ICSI (68% vs 89%) and increased quality of D3 embryos was seen in the piezo groups compared to conventional ICSI. It is hypothesised that the lack of cytoplasmic aspiration coupled with a smaller injection site results in less oocyte damage and is the reason behind the improved outcomes seen. Patients will be recruited from Repromed Dulwich ICSI patient group that have booked on for treatment. To determine the efficacy of this technology initially patients recruited will need to meet the following inclusion criteria to ensure adequate oocytes retrieved so fertilisation data and embryos quality can be assessed in a statistically meaningful manner: Couple for whom the treating clinician recommends ICSI as insemination method of choice and those that have 6 or more mature oocytes for injection post egg retrieval. The hypothesis for this trial is that the use of piezo ICSI technology will increase fertilisation rates and decrease oocyte degeneration rates compared to conventional ICSI. Patient’s outcomes will be compared to a matched cohort of patients that are not participating in the Piezo trial undertaking treatment at a similar time in a 1:2 fashion. The proposed research protocol is as follows: 1. Patients interested in partaking in the trial will be provided with information sheet and consent form and will be contacted by the research team and provided the information sheet and consent form via email and opportunity to ask questions. Patients will be approached by recruitment staff from the list of patients booked on for ICSI treatment. 2. Consent to partake will need to be obtained on or before the day of egg retrieval 3. Patients will be flagged on paperwork at egg retrieval that they are participating in the PIEZO trial so lab can activate plan 4. If patient has less than 6 mature oocytes for injection they will be unable to partake in the trial as this is insufficient number of oocytes to draw adequate conclusions and will instead be inseminated via conventional ICSI 5. If patient has greater than or equal to 6 mature oocytes from injection they will be fully enrolled in the trial and oocytes will be piezo injected 6. Normal laboratory practice occurs from this point onwards
Interventions
This trial is for the use of an alternative method for intracytoplasmic sperm injection (ICSI) using a Piezo ICSI machine. Piezo ICSI will be performed by trained senior embryologists at Repromed for our patients that have consented to partaking in the trial. The most common form of ICSI uses a bevelled spiked pipette to penetrate the zona pellucid where the cytoplasm is aspirated into the micropipette to break the membrane. After the membrane is broken the sperm is injected into the cytoplasm and the micropipette is withdrawn (termed conventional ICSI). In piezo-ICSI a piezoelectric actuator is used to move the capillary in an ultra rapid fashion by producing ultra-fast submicron motion which propels the capillary forward. The way this works is that the actuator is made of material that when a voltage is applied it changes shape and thus extrudes a force which moves the capillary in a forward jack hammer like motion. This technique is a more ‘gentle’ approach to the standard ICSI technique and therefore may improve outcomes as there is no bevel or spike on the pipette and may reduce the level of damage on the egg. The duration of the sperm injection procedure depends on the number of eggs being injected however, the time spent per egg should not significantly differ from the standard. despite this the time for each egg injected will be recorded and compared to routine ICSI cases to ensure they are comparable. All injections will be undertaken by trial co-investigators.
Sponsors
Study design
Eligibility
Inclusion criteria
All participants must be patients of Repromed who have booked on for IVF treatment where their clinician recommends ICSI as insemination method of choice. Consenting patients must have greater than or equal to 6 mature oocytes for injection post egg retrieval.
Exclusion criteria
Gamete donor cycles Surgical sperm collection requirements Previous cycle with an ICSI fertilisation of <30%