Will Piezo-ICSI Increase Fertilization Rates Compared to Conventional ICSI? A Prospective Randomized Sibling Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Vitrolife
- Enrollment
- 265
- Locations
- 4
- Primary Endpoint
- Fertilization rate
Study Overview
Brief 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 fertilization. This technique is intrusive, has a relatively long learning curve and variable operator performance.
A new injection technique called piezo-ICSI has recently been introduced. During piezo-ICSI, a piezo-electric effect is generated through the conversion of electric energy to mechanical energy. This causes a smooth movement of the injection pipette, which allows for steady, controlled microinjections with less psychical stress applied on the oocytes than by the conventional technique.
A recent analysis, based on data from 9 different studies comparing conventional ICSI and piezo-ICSI (17500 cases), showed a benefit of piezo. Unfortunately, proper randomized trials are missing from this analysis. The proposed study is a randomized controlled study 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.
Whether 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients receiving controlled ovarian stimulation with gonadotrophins needing ICSI for fertilizing oocytes.
- •Availability of at least six mature oocytes (MII) after oocyte pick-up.
- •Planned blastocyst culture.
Exclusion Criteria
- •Intention to perform any form of preimplantation genetic testing
- •The use of IMSI or polarized light in the ICSI process
- •The use of assisted hatching prior to randomization.
- •Surgical sperm retrieval (SSR) patients.
- •Previous participation in this RCT
- •Concurrent participation in another investigation that can affect the primary outcome of this study.
- •Sperm sample with <0.1million/ml or motility of <2% after preparation.
- •Fertility preservation cycles.
- •If a day 2-4 transfer is planned
- •Use of vitrified oocytes.
Outcomes
Primary Outcomes
Fertilization rate
Time Frame: Oocytes will be observed over a period of 26 hours after the intervention
Number of normally fertilized oocytes per injected oocytes
Secondary Outcomes
- Differences in KID scores.(Embryos will be observed over a period of 6 days after the procedure)
- Percentage of degenerated oocytes(Oocytes will be observed over a period of 26 hours after the intervention)
- Percentage of cryopreserved blastocysts on day 5 and 6.(Embryos will be observed over a period of 6 days after the procedure)
- Percentage of 0 PN oocytes(Oocytes will be observed over a period of 26 hours after the intervention)
- 8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate(Embryos will be observed over a period of 6 days after the procedure)
- Percentage of 1 PN oocytes.(Oocytes will be observed over a period of 26 hours after the intervention)
- Percentage of >2PN oocytes.(Oocytes will be observed over a period of 26 hours after the intervention)
- Differences in iDA scores.(Embryos will be observed over a period of 6 days after the procedure)
- Blastocyst rate (number of grade 3 or higher).(Embryos will be observed over a period of 6 days after the procedure)