Evaluating Piezo-ICSI. - The EPI Study.

Not Applicable

Suspended

• Conditions: IVF; Infertility
• Interventions: Device: Piezo-ICSI

• Registration Number: NCT04669652
• Lead Sponsor: Vitrolife

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-17
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-27
• Study Start: 2023-09
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 265

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Fertilization rate	Oocytes will be observed over a period of 26 hours after the intervention	Number of normally fertilized oocytes per injected oocytes

Secondary Outcome Measures

Name	Time	Method
Differences in KID scores.	Embryos will be observed over a period of 6 days after the procedure	Embryo development will be analysed using a mathematical models called KID (0-10 scale).
Percentage of degenerated oocytes	Oocytes will be observed over a period of 26 hours after the intervention	Number of oocytes that have degenerated after the procedure
Percentage of cryopreserved blastocysts on day 5 and 6.	Embryos will be observed over a period of 6 days after the procedure	Number of blastocysts cryopreserved on day 5 and day 6.
Percentage of 0 PN oocytes	Oocytes will be observed over a period of 26 hours after the intervention	Number of oocytes not fertilized (0 PN) after the procedure.
8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate	Embryos will be observed over a period of 6 days after the procedure	Number of transferred and cryopreserved blastocysts
Percentage of 1 PN oocytes.	Oocytes will be observed over a period of 26 hours after the intervention	Number of oocytes fertilized with one pronuclei (1 PN) after the procedure.
Percentage of >2PN oocytes.	Oocytes will be observed over a period of 26 hours after the intervention	Number of oocytes fertilized with more than 2 pronuclei (\>2PN) after the procedure.
Differences in iDA scores.	Embryos will be observed over a period of 6 days after the procedure	Embryo development will be analyzed using a artificial intelligence model, called iDA (0-10 scale).
Blastocyst rate (number of grade 3 or higher).	Embryos will be observed over a period of 6 days after the procedure	Number of blastocysts with a morphological score of grade 3 or higher.

Trial Locations

Locations (2)

Nurture Fertility (TFP); 🇬🇧 Nottingham, United Kingdom

Oxford Fertility (TFP); 🇬🇧 Oxford, United Kingdom