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

Not Applicable

Recruiting

• Conditions: Infertility
• Interventions: Other: Zona Pellucida-Bound Sperm Selection for ICSI; Other: Routine Embryologist Selected Sperm

• Registration Number: NCT05859152
• Lead Sponsor: IVI America

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-12
• Study First Posted: 2023-05-15
• Study Start: 2023-11-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZP Bound Sperm Selection Oocyte Cohort	Zona Pellucida-Bound Sperm Selection for ICSI	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.
Routine Care: Embryologist Selected Sperm Oocyte Cohort	Routine Embryologist Selected Sperm	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.

Primary Outcome Measures

Name	Time	Method
Blastulation Rate	one week after the vaginal oocyte retrieval and ICSI procedure	Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.

Secondary Outcome Measures

Name	Time	Method
Fertilization Rate	24 hours post ICSI procedure	fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Blastocyst Ploidy Rate	Approximately 2 weeks after trophectoderm biopsy	Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups
Sustained Implantation Rates	Approximately 6 weeks after frozen embryo transfer procedure	The number of participants discharged at 8-9 weeks gestational age to their obstetrician.

Trial Locations

Locations (1)

Reproductive Medicine Associates of Northern California; 🇺🇸 San Francisco, California, United States