Evaluating Piezo-ICSI. - The EPI Study.

NCT04669652 | Suspended

• 1 other identifier: 4026 - EPI
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 2

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

Keywords

ICSI; Fertilization; Piezo-ICSI; Oocyte; Blastocyst rate

Outcome Measures

Primary Outcomes (1)

• Fertilization rate

  Number of normally fertilized oocytes per injected oocytes

  Oocytes will be observed over a period of 26 hours after the intervention

Secondary Outcomes (9)

• Percentage of degenerated oocytes

  Oocytes will be observed over a period of 26 hours after the intervention

• Percentage of 0 PN oocytes

  Oocytes will be observed over a period of 26 hours after the intervention

• 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 KID scores.

  Embryos will be observed over a period of 6 days after the procedure

Study Arms (2)

ICSI

NO INTERVENTION

Traditional microinjection (ICSI) is performed on oocytes.

Piezo-ICSI

EXPERIMENTAL

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

Device: Piezo-ICSI

Interventions

Piezo-ICSI 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.

Piezo-ICSI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitrolife: lead

Study Sites (2)

Nurture Fertility (TFP)

Nottingham, NG10 5QG, United Kingdom

Location

Oxford Fertility (TFP)

Oxford, OX4 2HW, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Scott Nelson, MD, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A sibling study randomizing oocytes to 2 study groups.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 17, 2020
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)