Clinical trial NCT04669652: Evaluating Piezo-ICSI. - The EPI Study.
Official title: Will Piezo-ICSI Increase Fertilization Rates Compared to Conventional ICSI? A Prospective Randomized Sibling Study.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: IVF
Infertility
Keywords: ICSI
Fertilization
Piezo-ICSI
Oocyte
Blastocyst rate
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 265
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A sibling study randomizing oocytes to 2 study groups.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients receiving controlled ovarian stimulation with gonadotrophins needing ICSI for fertilizing oocytes.
2. Availability of at least six mature oocytes (MII) after oocyte pick-up.
3. Planned blastocyst culture.

Exclusion Criteria:

1. Intention to perform any form of preimplantation genetic testing
2. The use of IMSI or polarized light in the ICSI process
3. The use of assisted hatching prior to randomization.
4. Surgical sperm retrieval (SSR) patients.
5. Previous participation in this RCT
6. Concurrent participation in another investigation that can affect the primary outcome of this study.
7. Sperm sample with \<0.1million/ml or motility of \<2% after preparation.
8. Fertility preservation cycles.
9. If a day 2-4 transfer is planned
10. Use of vitrified oocytes.

Primary outcomes:
measure: Fertilization rate
timeFrame: Oocytes will be observed over a period of 26 hours after the intervention
Secondary outcomes:
measure: Percentage of degenerated oocytes
timeFrame: Oocytes will be observed over a period of 26 hours after the intervention
measure: Percentage of 0 PN oocytes
timeFrame: Oocytes will be observed over a period of 26 hours after the intervention
measure: Percentage of 1 PN oocytes.
timeFrame: Oocytes will be observed over a period of 26 hours after the intervention
measure: Percentage of >2PN oocytes.
timeFrame: Oocytes will be observed over a period of 26 hours after the intervention
measure: Differences in KID scores.
timeFrame: Embryos will be observed over a period of 6 days after the procedure
measure: Differences in iDA scores.
timeFrame: Embryos will be observed over a period of 6 days after the procedure
measure: Blastocyst rate (number of grade 3 or higher).
timeFrame: Embryos will be observed over a period of 6 days after the procedure
measure: Percentage of cryopreserved blastocysts on day 5 and 6.
timeFrame: Embryos will be observed over a period of 6 days after the procedure
measure: 8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate
timeFrame: Embryos will be observed over a period of 6 days after the procedure
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nurture Fertility (TFP)
city: Oxford
country: United Kingdom
facility: Oxford Fertility (TFP)
Study officials:
affiliation: University of Glasgow
name: Scott Nelson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: