Automated Intracytoplasmic Sperm Injection (ICSIA) (ICSIA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Device: Investigational device named ICSIA; Device: Manual ICSI

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • New Hope Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Infertile women undergoing IVF treatment with ICSI

Exclusion Criteria:

• Severe male factor infertility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICSIA; Intracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device)	Device: Investigational device named ICSIA; Oocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device.
Experimental: Control; In this control group oocytes will undergo manual ICSI as is routinely performed.	Device: Manual ICSI; Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	It refers to the integrity of the oocytes after sperm injection out of the total number of oocytes injected.	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.	Between 16 hours and 20 hours post-ICSI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastocyst rates	Refers to the number of fertilized embryos that develop into a good quality blastocyst after 5-7 days of in vitro culture	Between 120 hours and 168 hours post-ICSI
Euploidy rates	Refers to the number of blastocysts that are biopsied that are diagnosed as euploid	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.	6 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Overture Life
• Collaborators: New Hope Fertility Center
• Investigators: Principal Investigator: John Zhang, MD, New Hope Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: 09-21-2021_V1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No