Last updated: April 17, 2024
Sponsor: IVI America
Overall Status: Active - Recruiting
Phase
N/A
Condition
Infertility
Treatment
Routine Embryologist Selected Sperm
Zona Pellucida-Bound Sperm Selection for ICSI
Clinical Study ID
NCT05859152
IVIRMA-NorCal-Z01
Ages 18-41 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Undergoing their first in vitro fertilization (IVF) cycle
- 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 >18years 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 bindingco-incubation procedure
- Intention to transfer the morphological best quality, euploid, embryo at the frozenembryo transfer procedure
Exclusion
Exclusion Criteria:
- Contraindication to IVF
- Clinical indication for preimplantation genetic testing (i.e., screening for singlegene disorder, chromosomal translocation, or any other disorders requiring a moredetailed 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 epididymalretrieval procedures
- Uncorrected hydrosalpinges that communicate with the endometrial cavity
- Endometrial Insufficiency, as defined by a prior cycle with maximal endometrialthickness <6mm,), or persistent endometrial fluid
- Donor oocyte cycles
- Gestational carriers
Study Design
Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Routine Embryologist Selected Sperm
Phase:
Study Start date:
November 03, 2023
Estimated Completion Date:
June 30, 2026
Study Description
Connect with a study center
Reproductive Medicine Associates of Northern California
San Francisco, California 94105
United StatesActive - Recruiting
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