Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2022-12-05
2024-11-30
Brief Summary
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Detailed Description
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ICSIA is composed of the same devices and consumables used for manual ICSI, but these devices have been integrated using a software interface with artificial intelligence to identify oocytes and allow for proper puncture of the oocyte and injection of the sperm without human intervention. The information from this study will be used by the study Sponsor, Overture Life, Inc, to help future development of the System and for submission of data to the United States Food and Drug Administration (FDA).
During the study, patients will undergo a conventional IVF cycle, or donor IVF cycle. After the oocyte retrieval or thawing of donor oocytes, the oocytes will be placed into equal groups: test and control. Test group oocytes will undergo ICSI via ICSIA (the investigational device), and control group oocytes will undergo manual ICSI as is routinely performed. The oocytes will be immediately evaluated for survival and fertilization rates and remain separate for the duration of the study. ICSIA has been extensively tested in hamster and mice oocytes, and fertilization/survival rates after ICSIA have been between 89%-96%.
After ICSI, conventional IVF processes will be followed and fertilized oocytes cultured up to blastocyst stage. Blastocysts will be biopsied for preimplantation genetic testing for aneuploidy (PGT-A) which assesses the embryo's chromosomes. All biopsied blastocysts will be frozen, and frozen embryo transfers (FET) scheduled after genetic results have been received. Embryo freezing and thaw will be performed manually. Selection of the embryo for transfer (whether test or control) will be at random.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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ICSIA
Intracytoplasmic sperm injection will be performed using the automated system named ICSIA (investigational device)
Investigational device named ICSIA
Oocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device.
Control
In this control group oocytes will undergo manual ICSI as is routinely performed.
Manual ICSI
Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol
Interventions
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Investigational device named ICSIA
Oocytes will undergo intracytoplasmic sperm injection using the ICSIA (the investigational) device.
Manual ICSI
Oocytes will undergo intracytoplasmic sperm injection using the ICSI manual protocol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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New Hope Fertility Center
OTHER
Overture Life
INDUSTRY
Responsible Party
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Principal Investigators
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John Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
New Hope Fertility Center
Locations
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New Hope Fertility Center
New York, New York, United States
Countries
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Other Identifiers
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09-21-2021_V1.0
Identifier Type: -
Identifier Source: org_study_id
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