Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection (NCT05859152) | Clinical Trial Compass
CompletedNot Applicable
Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
United States29 participantsStarted 2023-11-03
Plain-language summary
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.
Who can participate
Age range18 Years – 41 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \>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:
* 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 ca…
What they're measuring
1
Blastulation Rate
Timeframe: one week after the vaginal oocyte retrieval and ICSI procedure