Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
NCT ID: NCT05859152
Last Updated: 2026-01-21
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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COMPLETED
NA
29 participants
INTERVENTIONAL
2023-11-03
2025-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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ZP Bound Sperm Selection Oocyte Cohort
This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure with sperm that has bound to the ZP of an immature oocyte.
Zona Pellucida-Bound Sperm Selection for ICSI
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte.
Routine Care: Embryologist Selected Sperm Oocyte Cohort
This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure per routine with sperm that is subjectively selected by the embryologist (based on morphology and mobility characteristics). This is the current standard of care for ICSI.
Routine Embryologist Selected Sperm
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine.
Interventions
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Zona Pellucida-Bound Sperm Selection for ICSI
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte.
Routine Embryologist Selected Sperm
one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine.
Eligibility Criteria
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Inclusion Criteria
* Electing single embryo transfer
* Electing preimplantation genetic testing for aneuploidy (PGT-A) of their embryos
* Female partners age \<42 years old at start of vaginal oocyte retrieval cycle, but \>18 years old.
* Normal ovarian reserve:
* Antimullerian hormone level (AMH) ≥ 1.2 ng/mL
* Antral follicle count (AFC) ≥ 8
* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
* At least 1 immature oocyteretrieved at the VOR procedure to perform ZP binding co-incubation procedure
* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
Exclusion Criteria
* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
* Male partner with azoospermia or oligozoospermia (\<100,000 total motile spermatozoa)
* Male partner with Y-chromosome microdeletion
* Male partner with any Karyotype other than 46,XY
* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
* Uncorrected hydrosalpinges that communicate with the endometrial cavity
* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
* Donor oocyte cycles
* Gestational carriers
18 Years
41 Years
ALL
No
Sponsors
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IVI America
OTHER
Responsible Party
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Locations
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Reproductive Medicine Associates of Northern California
San Francisco, California, United States
Countries
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Other Identifiers
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IVIRMA-NorCal-Z01
Identifier Type: -
Identifier Source: org_study_id
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