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

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

NCT05859152•IVI America

View on ClinicalTrials.gov

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

Age

18 - 41 years

Sex

ALL

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

Locations (1)

Reproductive Medicine Associates of Northern California

San Francisco, California, United States

Key Dates

Start Date

November 3, 2023

Primary Completion Date

December 2, 2024

Completion Date

September 14, 2025

Last Updated

January 21, 2026

Enrollment

ACTUAL participants

Conditions

Infertility

Interventions

Zona Pellucida-Bound Sperm Selection for ICSI

OTHER

Routine Embryologist Selected Sperm

OTHER

Immune Cell Populations in the Endometrium

NCT06826365

Infertility, FemaleRecurrent Miscarriage+1 more

View study

RECRUITINGPHASE2

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

NCT07153367

InfertilityInsemination

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Immune Cell Populations in the Endometrium

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

Effect Clomiphene vs Clomiphene Along With Pioglitazone on Ovarian Stimulation Rate

Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET

Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

Efficacy and Safety of a New Sperm Capacitation Method