Control for Female Infertility

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Female InfertilityInvestigational device named ICSIA - Device
Eligibility
18 - 50
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Female Infertility

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 1 month after biopsy

1 month after biopsy
Euploidy rates
Week 6
Clinical pregnancy rates
Hour 2
Survival rates
Hour 168
Blastocyst rates
Hour 20
Fertilization rates

Trial Safety

Trial Design

2 Treatment Groups

Control
1 of 2
ICSIA
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Control · No Placebo Group · N/A

Control
Device
Experimental Group · 1 Intervention: Manual ICSI · Intervention Types: Device
ICSIA
Device
Experimental Group · 1 Intervention: Investigational device named ICSIA · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month after biopsy

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 50 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Louisiana100.0%
What site did they apply to?
New Hope Fertility Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%