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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Other: Zona Pellucida-Bound Sperm Selection for ICSI
* Other: Routine Embryologist Selected Sperm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZP Bound Sperm Selection Oocyte Cohort<br>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. | Other: Zona Pellucida-Bound Sperm Selection for ICSI<br>* 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.<br>|
| Other: Routine Care: Embryologist Selected Sperm Oocyte Cohort<br>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. | Other: Routine Embryologist Selected Sperm<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation Rate | Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI. | one week after the vaginal oocyte retrieval and ICSI procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracytoplasmic Sperm Injection Procedure, ICSI