Automated Intracytoplasmic Sperm Injection (ICSIA)

NCT05633316 | Unknown FDA Device

• 1 other identifier: 09-21-2021_V1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Blastocyst rates

  Between 120 hours and 168 hours post-ICSI

• Euploidy rates

  1 month after biopsy

• Clinical pregnancy rates

  6 weeks after embryo transfer

Study Arms (2)

ICSIA

EXPERIMENTAL

Intracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device)

Device: Investigational device named ICSIA

Control

EXPERIMENTAL

In this control group oocytes will undergo manual ICSI as is routinely performed.

Device: Manual ICSI

Interventions

Investigational device named ICSIA DEVICE

Oocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device.

ICSIA

Manual ICSI DEVICE

Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Infertile women undergoing IVF treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women undergoing IVF treatment with ICSI

You may not qualify if:

• Severe male factor infertility

Sponsors & Collaborators

• Overture Life: lead
• New Hope Fertility Center: collaborator

Study Sites (1)

New Hope Fertility Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• John Zhang, MD

  New Hope Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 1, 2022
• Study Start: December 5, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)