IVFNCT04669652
Evaluating Piezo-ICSI. - The EPI Study.
A study testing Piezo-ICSI in people with IVF and Infertility, run by Vitrolife at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IVF, Infertility
- What is being tested?
- Piezo-ICSI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nurture Fertility (TFP)
Nottingham, NG10 5QG
Oxford Fertility (TFP)
Oxford, OX4 2HW
About this study
Official title: Will Piezo-ICSI Increase Fertilization Rates Compared to Conventional ICSI? A Prospective Randomized Sibling Study.
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.
Read more
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
- Being tested
- Piezo-ICSI
- Keywords
- ICSI, Fertilization, Piezo-ICSI, Oocyte, Blastocyst rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezo-ICSIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ICSI | No intervention | Traditional microinjection (ICSI) is performed on oocytes. |
| Piezo-ICSI | Experimental | Microinjection (ICSI) is performed using the Piezo-ICSI technique. Receives: Device: Piezo-ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Number of normally fertilized oocytes per injected oocytes
Measured: Oocytes will be observed over a period of 26 hours after the intervention
Secondary outcomes (9)
Percentage of degenerated oocytes
Number of oocytes that have degenerated after the procedure
Measured: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of 0 PN oocytes
Number of oocytes not fertilized (0 PN) after the procedure.
Measured: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of 1 PN oocytes.
Number of oocytes fertilized with one pronuclei (1 PN) after the procedure.
Measured: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of >2PN oocytes.
Number of oocytes fertilized with more than 2 pronuclei (>2PN) after the procedure.
Measured: Oocytes will be observed over a period of 26 hours after the intervention
Differences in KID scores.
Embryo development will be analysed using a mathematical models called KID (0-10 scale).
Measured: Embryos will be observed over a period of 6 days after the procedure
Differences in iDA scores.
Embryo development will be analyzed using a artificial intelligence model, called iDA (0-10 scale).
Measured: Embryos will be observed over a period of 6 days after the procedure
Blastocyst rate (number of grade 3 or higher).
Number of blastocysts with a morphological score of grade 3 or higher.
Measured: Embryos will be observed over a period of 6 days after the procedure
Percentage of cryopreserved blastocysts on day 5 and 6.
Number of blastocysts cryopreserved on day 5 and day 6.
Measured: Embryos will be observed over a period of 6 days after the procedure
8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate
Number of transferred and cryopreserved blastocysts
Measured: Embryos will be observed over a period of 6 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: Study on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A sibling study randomizing oocytes to 2 study groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Nelson, MD, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669652
- Sponsor's protocol ID
- 4026 - EPI
- Status last verified
- Oct 2022
- First submitted
- 1 Dec 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Piezo-ICSI Increase Fertilization Rates Compared to Conventional ICSI? A Prospective Randomized Sibling Study.
- ClinicalTrials.gov ID
- NCT04669652
- Acronym / sponsor ID
- 4026 - EPI
- Conditions
- IVF, Infertility
- Keywords
- ICSI, Fertilization, Piezo-ICSI, Oocyte, Blastocyst rate
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study on hold
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A sibling study randomizing oocytes to 2 study groups.
| Arm | Type | Receives |
|---|---|---|
| ICSI | No intervention | –Traditional microinjection (ICSI) is performed on oocytes. |
| Piezo-ICSI | Experimental | Device: Piezo-ICSIMicroinjection (ICSI) is performed using the Piezo-ICSI technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piezo-ICSIDuring 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. | Device | Piezo-ICSI |
Primary outcome
Fertilization rate
Time frame: Oocytes will be observed over a period of 26 hours after the intervention
Number of normally fertilized oocytes per injected oocytes
9 secondary outcomes
Percentage of degenerated oocytes
Time frame: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of 0 PN oocytes
Time frame: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of 1 PN oocytes.
Time frame: Oocytes will be observed over a period of 26 hours after the intervention
Percentage of >2PN oocytes.
Time frame: Oocytes will be observed over a period of 26 hours after the intervention
Differences in KID scores.
Time frame: Embryos will be observed over a period of 6 days after the procedure
Differences in iDA scores.
Time frame: Embryos will be observed over a period of 6 days after the procedure
Blastocyst rate (number of grade 3 or higher).
Time frame: Embryos will be observed over a period of 6 days after the procedure
Percentage of cryopreserved blastocysts on day 5 and 6.
Time frame: Embryos will be observed over a period of 6 days after the procedure
8. Utilization rate (Number of transferred and cryopreserved blastocysts). Utilization rate
Time frame: Embryos will be observed over a period of 6 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Nelson, MD, PhD principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezo-ICSI in people with IVF and Infertility, run by Vitrolife at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: Oocytes will be observed over a period of 26 hours after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.