What side effects are associated with this type of intervention?

Common treatments for female infertility similar to Overture's automated ICSIA system include manual Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF). Known side effects of these treatments can include ovarian hyperstimulation syndrome (OHSS), which causes swollen and painful ovaries, multiple pregnancies, which increase the risk of complications for both mother and babies, and procedural risks such as bleeding, infection, and damage to the reproductive organs. Additionally, the use of hormonal medications can lead to mood swings, headaches, and abdominal pain.

What prior FDA approvals exist?

The FDA has approved several treatments for female infertility, particularly those used in assisted reproductive technologies (ART) like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). Key drugs include clomiphene citrate and letrozole for ovulation induction, as well as gonadotropins like follicle-stimulating hormone (FSH) and luteinizing hormone (LH) for controlled ovarian hyperstimulation. Additionally, progesterone is commonly used for luteal phase support to enhance the chances of implantation and pregnancy. These treatments aim to optimize the development and fertilization of oocytes, similar to the goals of the ICSIA system being studied.

What other types of research exist?

Promising alternatives to Overture's automated ICSIA system for female infertility patients include: 1) Time-lapse embryo imaging systems, which improve embryo selection and reproductive outcomes by continuously monitoring embryo development. 2) Preimplantation genetic testing (PGT), which screens embryos for genetic abnormalities to increase the chances of successful implantation and healthy pregnancy. 3) Advanced ovarian stimulation protocols, such as the use of gonadotropin-releasing hormone (GnRH) antagonists, which reduce the risk of ovarian hyperstimulation syndrome (OHSS) while optimizing egg retrieval. 4) Metabolomics, which analyzes the metabolic profile of embryos to select the most viable ones for transfer. These alternatives offer innovative approaches to enhance the success rates of ART procedures.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after biopsy for reporting.

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.

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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.