Evaluating Piezo-ICSI. - The EPI Study.

Status Suspended

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04669652
Study type	Interventional
Source	Vitrolife
Contact
Status	Suspended
Phase	N/A
Start date	September 2023
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03607409` - Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Recruiting	`NCT02312076` - GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles	Phase 4
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Completed	`NCT03287479` - Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)	N/A
Terminated	`NCT03522350` - Randomized Trial Comparing EmbryoScope With EmbryoScope+.	N/A
Completed	`NCT04496284` - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen	N/A
Completed	`NCT03623659` - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts	N/A
Completed	`NCT03895099` - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors	Phase 3
Active, not recruiting	`NCT04142112` - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation	N/A
Completed	`NCT03152643` - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer	N/A
Recruiting	`NCT03683771` - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting	`NCT03161119` - Comparing Two Different Embryo Transfer Catheters	N/A
Completed	`NCT04108039` - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.	N/A
Completed	`NCT03678597` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)	N/A
Completed	`NCT03678610` - Handling Medium for ICSI With Ionomycin and Latrunculin A	N/A
Completed	`NCT03678558` - Oocyte Vitrification Aided With Cytochalasin B	N/A
Completed	`NCT03678818` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)	N/A
Completed	`NCT03678571` - Oocyte Vitrification Aided With Latrunculin A	N/A
Completed	`NCT03678584` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)	N/A
Completed	`NCT03677492` - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)	N/A