Your session is about to expire
← Back to Search
Procedure
Automated ICSI for Infertility (ICSIA Trial)
N/A
Waitlist Available
Led By John Zhang, MD
Research Sponsored by Overture Life
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after biopsy
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new machine that automatically injects sperm into eggs for IVF patients. The machine uses smart technology to make the process more consistent and efficient.
Who is the study for?
This trial is for women experiencing infertility who are undergoing IVF treatment with ICSI. It's not suitable for cases where the cause of infertility is due to severe male factors.
What is being tested?
The study tests an automated system called ICSIA against the standard manual method of injecting sperm into eggs during IVF. The focus is on comparing how many eggs survive and get fertilized with each technique.
What are the potential side effects?
Since this trial involves a device rather than a drug, side effects may include typical IVF-related risks such as discomfort or bruising from egg retrieval, but specific device-related side effects are not detailed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month after biopsy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after biopsy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fertilization rates
Survival rates
Secondary study objectives
Blastocyst rates
Clinical pregnancy rates
Euploidy rates
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: ICSIAExperimental Treatment1 Intervention
Intracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device)
Group II: ControlExperimental Treatment1 Intervention
In this control group oocytes will undergo manual ICSI as is routinely performed.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for female infertility include ovulation induction (OI), in vitro fertilization (IVF), and intracytoplasmic sperm injection (ICSI). OI involves the use of medications like clomiphene citrate to stimulate the ovaries to produce multiple eggs, increasing the chances of conception.
IVF involves hormonally stimulating the ovaries, retrieving eggs, fertilizing them with sperm in a lab, and transferring the resulting embryos into the uterus. ICSI, which is similar to the ICSIA system being studied, involves directly injecting a single sperm into an egg to facilitate fertilization, particularly useful in cases of male infertility or previous fertilization failures.
These treatments are crucial for female infertility patients as they address various underlying issues, enhancing the likelihood of achieving a successful pregnancy.
Find a Location
Who is running the clinical trial?
Overture LifeLead Sponsor
3 Previous Clinical Trials
687 Total Patients Enrolled
New Hope Fertility CenterOTHER
4 Previous Clinical Trials
1,128 Total Patients Enrolled
John Zhang, MDPrincipal InvestigatorNew Hope Fertility Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: ICSIA
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Female Infertility Patient Testimony for trial: Trial Name: NCT05633316 — N/A