Infertility, FemaleICSIANCT05633316
Automated Intracytoplasmic Sperm Injection (ICSIA)
A study testing Investigational device named ICSIA and Manual ICSI in people with Infertility, Female, run by Overture Life at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Investigational device named ICSIA and Manual ICSI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 30 Nov 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile women undergoing IVF treatment with ICSI
Who cannot join
- Severe male factor infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paired Non Inferiority Study Comparing Overture's Intracytoplasmic Sperm Injection Automated (ICSIA) System to the Standard Manual ICSI Process
The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs. This study will evaluate survival and fertilization rates of oocytes handled via ICSIA and compare to survival and fertilization rates of oocytes which are manually injected with sperm.
Read the detailed description
Today Intracytoplasmic Sperm Injection (ICSI) is performed manually; a highly skilled technician manually injects a single sperm cell into an oocyte using a set of microinjectors. Success of ICSI is contingent on operator skills and has a direct impact on the number of fertilized oocytes available and cumulative pregnancy rates. Automation of the ICSI technique may help improve consistency and efficiency of the process, as well as improve reproducibility across operators. Overture has developed the ICSI system to automate these critical processes, named ICSIA.
ICSIA is composed of the same devices and consumables used for manual ICSI, but these devices have been integrated using a software interface with artificial intelligence to identify oocytes and allow for proper puncture of the oocyte and injection of the sperm without human intervention. The information from this study will be used by the study Sponsor, Overture Life, Inc, to help future development of the System and for submission of data to the United States Food and Drug Administration (FDA).
During the study, patients will undergo a conventional IVF cycle, or donor IVF cycle. After the oocyte retrieval or thawing of donor oocytes, the oocytes will be placed into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed. The oocytes will be immediately evaluated for survival and fertilization rates and remain separate for the duration of the study. ICSIA has been extensively tested in hamster and mice oocytes, and fertilization/survival rates after ICSIA have been between 89%-96%.
After ICSI, conventional IVF processes will be followed and fertilized oocytes cultured up to blastocyst stage. Blastocysts will be biopsied for preimplantation genetic testing for aneuploidy (PGT-A) which assesses the embryo's chromosomes. All biopsied blastocysts will be frozen, and frozen embryo transfers (FET) scheduled after genetic results have been received. Embryo freezing and thaw will be performed manually. Selection of the embryo for transfer (whether test or control) will be at random.
- Conditions
- Infertility, Female
- Being tested
- Investigational device named ICSIA, Manual ICSI
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device named ICSIADevice
Oocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device.
Manual ICSIDevice
Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol
| Study group | Role | What they receive |
|---|---|---|
| ICSIA | Experimental | Intracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device) Receives: Device: Investigational device named ICSIA |
| Control | Experimental | In this control group oocytes will undergo manual ICSI as is routinely performed. Receives: Device: Manual ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rates
It refers to the integrity of the oocytes after sperm injection out of the total number of oocytes injected.
Measured: Between 0 hours and 2 hours post-ICSI
Fertilization rates
It refers to the number of oocytes that show to be correctly fertilized showing two pronuclei and a second polar body out of the total number of oocytes injected.
Measured: Between 16 hours and 20 hours post-ICSI
Secondary outcomes (3)
Blastocyst rates
Refers to the number of fertilized embryos that develop into a good quality blastocyst after 5-7 days of in vitro culture
Measured: Between 120 hours and 168 hours post-ICSI
Euploidy rates
Refers to the number of blastocysts that are biopsied that are diagnosed as euploid
Measured: 1 month after biopsy
Clinical pregnancy rates
Refers to the number of patients that are replaced with an embryo and result pregnant with fetal heartbeat out of the total patients that are transferred.
Measured: 6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start5 Dec 2022
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the oocyte retrieval or thawing of donor oocytes, oocytes will be randomly assigned into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Overture Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Hope Fertility Center
- Responsible party
- Sponsor
- Investigators
- John Zhang, MD, Principal investigator, New Hope Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633316
- Sponsor's protocol ID
- 09-21-2021_V1.0
- Acronym
- ICSIA
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Non Inferiority Study Comparing Overture's Intracytoplasmic Sperm Injection Automated (ICSIA) System to the Standard Manual ICSI Process
- ClinicalTrials.gov ID
- NCT05633316
- Acronym / sponsor ID
- ICSIA / 09-21-2021_V1.0
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Overture LifeIndustry (pharma, biotech, devices)
- Collaborators
- New Hope Fertility Center
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Dec 2022 (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.
The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs. This study will evaluate survival and fertilization rates of oocytes handled via ICSIA and compare to survival and fertilization rates of oocytes which are manually injected with sperm.
Detailed description
Today Intracytoplasmic Sperm Injection (ICSI) is performed manually; a highly skilled technician manually injects a single sperm cell into an oocyte using a set of microinjectors. Success of ICSI is contingent on operator skills and has a direct impact on the number of fertilized oocytes available and cumulative pregnancy rates. Automation of the ICSI technique may help improve consistency and efficiency of the process, as well as improve reproducibility across operators. Overture has developed the ICSI system to automate these critical processes, named ICSIA.
ICSIA is composed of the same devices and consumables used for manual ICSI, but these devices have been integrated using a software interface with artificial intelligence to identify oocytes and allow for proper puncture of the oocyte and injection of the sperm without human intervention. The information from this study will be used by the study Sponsor, Overture Life, Inc, to help future development of the System and for submission of data to the United States Food and Drug Administration (FDA).
During the study, patients will undergo a conventional IVF cycle, or donor IVF cycle. After the oocyte retrieval or thawing of donor oocytes, the oocytes will be placed into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed. The oocytes will be immediately evaluated for survival and fertilization rates and remain separate for the duration of the study. ICSIA has been extensively tested in hamster and mice oocytes, and fertilization/survival rates after ICSIA have been between 89%-96%.
After ICSI, conventional IVF processes will be followed and fertilized oocytes cultured up to blastocyst stage. Blastocysts will be biopsied for preimplantation genetic testing for aneuploidy (PGT-A) which assesses the embryo's chromosomes. All biopsied blastocysts will be frozen, and frozen embryo transfers (FET) scheduled after genetic results have been received. Embryo freezing and thaw will be performed manually. Selection of the embryo for transfer (whether test or control) will be at random.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the oocyte retrieval or thawing of donor oocytes, oocytes will be randomly assigned into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed.
| Arm | Type | Receives |
|---|---|---|
| ICSIA | Experimental | Device: Investigational device named ICSIAIntracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device) |
| Control | Experimental | Device: Manual ICSIIn this control group oocytes will undergo manual ICSI as is routinely performed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Infertile women undergoing IVF treatment with ICSI
Key exclusion criteria (1 listed)
- Severe male factor infertility
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 |
|---|---|---|
| Investigational device named ICSIAOocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device. | Device | ICSIA |
| Manual ICSIOocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol | Device | Control |
Primary outcome
Survival rates
Time frame: Between 0 hours and 2 hours post-ICSI
It refers to the integrity of the oocytes after sperm injection out of the total number of oocytes injected.
Fertilization rates
Time frame: Between 16 hours and 20 hours post-ICSI
It refers to the number of oocytes that show to be correctly fertilized showing two pronuclei and a second polar body out of the total number of oocytes injected.
3 secondary outcomes
Blastocyst rates
Time frame: Between 120 hours and 168 hours post-ICSI
Euploidy rates
Time frame: 1 month after biopsy
Clinical pregnancy rates
Time frame: 6 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- 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.
John Zhang, MD principal investigator
New Hope Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device named ICSIA and Manual ICSI in people with Infertility, Female, run by Overture Life at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Survival rates (time frame: Between 0 hours and 2 hours post-ICSI). The study lists 2 primary outcomes in all. 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 6 Jul 2023.