Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection

IVI America

Status: Enrolling

Conditions: Infertility

Treatments: Other: Zona Pellucida-Bound Sperm Selection for ICSI; Other: Routine Embryologist Selected Sperm

Study type: Interventional

Funder types: Other

Identifiers

NCT05859152

IVIRMA-NorCal-Z01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

ZP Bound Sperm Selection Oocyte Cohort

Experimental group

Description:

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.

Treatment:

Other: Zona Pellucida-Bound Sperm Selection for ICSI

Routine Care: Embryologist Selected Sperm Oocyte Cohort

Other group

Description:

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.

Treatment:

Other: Routine Embryologist Selected Sperm