Clinical trial NCT05859152: Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
Official title: Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Keywords: Intracytoplasmic Sperm Injection Procedure
ICSI
Lead sponsor: IVI America
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: In this study, the investigators aim to determine the clinical utility of the ZP-bound sperm selection methodology for ICSI. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of sperm selection for ICSI via the embryologist versus sperm selected via ZP-binding for ICSI. Embryology, ploidy and clinical pregnancy outcomes will be assessed.

Eligibility criteria: 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 carriers

Primary outcomes:
measure: Blastulation Rate
timeFrame: one week after the vaginal oocyte retrieval and ICSI procedure
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 24 hours post ICSI procedure
measure: Blastocyst Ploidy Rate
timeFrame: Approximately 2 weeks after trophectoderm biopsy
measure: Sustained Implantation Rates
timeFrame: Approximately 6 weeks after frozen embryo transfer procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Reproductive Medicine Associates of Northern California
state: California
Study officials:
References: