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Automated Intracytoplasmic Sperm Injection (ICSIA)

NCT05633316 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-07-06

No results posted yet for this 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.

Conditions

  • Infertility, Female

Interventions

DEVICE

Investigational device named ICSIA

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

DEVICE

Manual ICSI

Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol

Sponsors & Collaborators

  • New Hope Fertility Center

    collaborator OTHER

  • Overture Life

    lead INDUSTRY

Principal Investigators

  • John Zhang, MD · New Hope Fertility Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2023-11-30
Completion
2024-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633316 on ClinicalTrials.gov