Evaluating Piezo-ICSI. - The EPI Study.

NCT ID: NCT04669652

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-10-31

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.

Conditions

IVF; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ICSI

Traditional microinjection (ICSI) is performed on oocytes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Piezo-ICSI

Microinjection (ICSI) is performed using the Piezo-ICSI technique.

Group Type: EXPERIMENTAL

Piezo-ICSI

Intervention Type: DEVICE

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 microinjection of a sperm with less psychical stress applied on the oocytes than by the conventional technique.

Interventions

Piezo-ICSI

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 microinjection of a sperm with less psychical stress applied on the oocytes than by the conventional technique.

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vitrolife

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Nelson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

Nurture Fertility (TFP)

Nottingham, , United Kingdom

Oxford Fertility (TFP)

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

4026 - EPI

Identifier Type: -

Identifier Source: org_study_id