Clinical trial NCT05633316: Automated Intracytoplasmic Sperm Injection (ICSIA)
Official title: Paired Non Inferiority Study Comparing Overture's Intracytoplasmic Sperm Injection Automated (ICSIA) System to the Standard Manual ICSI Process
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Overture Life
Sponsor class: INDUSTRY
Collaborators: name: New Hope Fertility Center
First posted: 2022-12-01
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Infertile women undergoing IVF treatment with ICSI

Exclusion Criteria:

* Severe male factor infertility

Primary outcomes:
measure: Survival rates
timeFrame: Between 0 hours and 2 hours post-ICSI
measure: Fertilization rates
timeFrame: Between 16 hours and 20 hours post-ICSI
Secondary outcomes:
measure: Blastocyst rates
timeFrame: Between 120 hours and 168 hours post-ICSI
measure: Euploidy rates
timeFrame: 1 month after biopsy
measure: Clinical pregnancy rates
timeFrame: 6 weeks after embryo transfer
Other outcomes:
Locations:
city: New York
country: United States
facility: New Hope Fertility Center
state: New York
Study officials:
affiliation: New Hope Fertility Center
name: John Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: