Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
Completed · Not applicable
Conditions studied: Infertility
In brief
This study aims to assess the clinical significance of the intracytoplasmic sperm injection (ICSI) with zona-pellucida (ZP) bound sperm compared to ICSI with embryologist selected sperm for patients undergoing in vitro fertilization treatment of their infertility.
Key facts
- Study ID
- NCT05859152
- Run by
- IVI America
- People needed
- 29
- Starts
- 2023-11-03
- Expected to finish
- 2025-09-14
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older, up to 41. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 >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
You may not qualify if…
- Contraindication to IVF
- 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
Where it is running
- Reproductive Medicine Associates of Northern California — San Francisco, California, United States
Full record on ClinicalTrials.gov
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