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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

ICSIA Trial Summary

This trial will compare how well an automated system does vs manual injection in fertilizing eggs and whether the eggs survive.

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.Check my eligibility
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.See study design
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.

ICSIA Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fertilization rates
Survival rates
Secondary outcome measures
Blastocyst rates
Clinical pregnancy rates
Euploidy rates

ICSIA 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.

Find a Location

Who is running the clinical trial?

Overture LifeLead Sponsor
3 Previous Clinical Trials
687 Total Patients Enrolled
New Hope Fertility CenterOTHER
3 Previous Clinical Trials
978 Total Patients Enrolled
John Zhang, MDPrincipal InvestigatorNew Hope Fertility Center

Media Library

ICSIA (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05633316 — N/A
Female Infertility Research Study Groups: ICSIA, Control
Female Infertility Clinical Trial 2023: ICSIA Highlights & Side Effects. Trial Name: NCT05633316 — N/A
ICSIA (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633316 — N/A
Female Infertility Patient Testimony for trial: Trial Name: NCT05633316 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for participants to join this experiment?

"This investigation is not accepting recruits at the present time, as per clinicaltrials.gov records which indicate the first posting of this trial to be December 31st 2022 and its last update on December 5th 2022. However, there are 247 additional trials actively recruiting patients right now."

Answered by AI

Does this trial accept participants of an advanced age?

"This medical trial has established an age requirement of 18-50. For patients below the minimum or above maximum, there are 14 trials for minors and 33 trials designed specifically with the elderly in mind."

Answered by AI

Is it possible to sign up for this research program?

"This research is seeking 10 female participants aged 18-50 who have been diagnosed with infertility and are undergoing In Vitro Fertilization (IVF) paired with Intracytoplasmic Sperm Injection (ICSI)."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
New York
Louisiana
What site did they apply to?
New Hope Fertility Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Trying to get pregnant for over a year. I’ve tried 3 cycles of chlomid, still not pregnant.
PatientReceived 2+ prior treatments
I’ve tried chlomid 3 times and still not pregnant. I have tried medicated IUI and it did not work, so I am hopeful this would help us achieve our dreams. We also really would love to help to find something that would help women get pregnant since we know what a struggle infertility has been for us.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the timing process for this trial?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Automated Intracytoplasmic Sperm Injection (ICSIA)
2022. "Automated Intracytoplasmic Sperm Injection (ICSIA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05633316.
All > Ivf > Infertility
~4 spots leftby Apr 2025
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