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

Description

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.

Conditions

Infertility

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Study Overview

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Study Details

Study overview

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.

Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm

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

Condition
Infertility
Intervention / Treatment

-

Contacts and Locations

San Francisco

Reproductive Medicine Associates of Northern California, San Francisco, California, United States, 94105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 41 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IVI America,

Study Record Dates

2026-06