Evaluating piezo-ICSI. The EPI study.
Research type
Research Study
Full title
Evaluating piezo-ICSI. The EPI study. Will Piezo-ICSI increase fertilization rates compared to conventional ICSI? A prospective randomized sibling study.
IRAS ID
289620
Contact name
Scott Nelson
Contact email
Sponsor organisation
Vitrolife AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Intracytoplasmic sperm injection (ICSI) has successfully been used to treat both severe male infertility and fertilization failure since its introduction in the early 1990´s. During the procedure a single sperm is injected into the cytoplasm of an oocyte to achieve fertilisation. This technique is intrusive and has a relatively long learning curve.\nA new injection technique called piezo-ICSI has recently been introduced. During piezo-ICSI, pipette movement is generated in response to an electric pulse, phenomenon known as the piezo-electric effect. This enables smother injections with better control and less physical stress applied on the oocytes than using the conventional technique.\nA recent analysis, based on data from 9 different cohort studies comparing conventional ICSI and piezo-ICSI (17500 cases), showed a benefit of piezo. Unfortunately, proper randomised trials are missing from this analysis. The proposed study is a randomized controlled trial carried out at two private IVF clinics. Eligible participants are patients undergoing ICSI treatment, with a minimum of 6 oocytes. The participants will act as their own controls, with their oocytes randomly and equally divided between injection by the investigated and the conventional technique.\nWhether piezo-ICSI is associated with improved success rates or reduction in adverse outcomes is at present unclear. Patients with fragile oocytes may benefit more from piezo-ICSI. In patients above 35 years, piezo-ICSI has been associated with a lower oocyte degeneration rate and an increased blastocyst rate. The aim of the study is to investigate whether the piezo-ICSI technique will result in more oocytes becoming normally fertilized compared to conventional ICSI. Another proposed benefit of piezo-ICSI lies in the standardization and simplification of the ICSI procedure. Making the injection procedure more independent of operator skill may result in a more robust and predictable laboratory output. \n\nSummary of Results: not applicable (the study was never initiated).
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0008
Date of REC Opinion
1 Mar 2021
REC opinion
Further Information Favourable Opinion