NCT05859152

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: IVI America · Academic / Other
• Sex: All
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	Zona Pellucida-Bound Sperm Selection for ICSI	one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that was bound to the ZP of an immature oocyte.
OTHER	Routine Embryologist Selected Sperm	one half of the patients' oocytes will be inseminated via the ICSI procedure with sperm that has been selected based on morphology and mobility characteristics by the embryologist per routine.

Timeline

• Start date: 2023-11-03
• Primary completion: 2024-12-02
• Completion: 2025-09-14
• First posted: 2023-05-15
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States