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

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

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.

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

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.

Connect with a study center

  • Reproductive Medicine Associates of Northern California

    San Francisco, California 94105
    United States

    Active - Recruiting

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