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

Primary Purpose

Infertility

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zona Pellucida-Bound Sperm Selection for ICSI
Routine Embryologist Selected Sperm
Sponsored by
IVI America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility focused on measuring Intracytoplasmic Sperm Injection Procedure, ICSI

Eligibility Criteria

18 Years - 41 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Reproductive Medicine Associates of Northern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ZP Bound Sperm Selection Oocyte Cohort

Routine Care: Embryologist Selected Sperm Oocyte Cohort

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blastulation Rate
Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.

Secondary Outcome Measures

Fertilization Rate
fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Blastocyst Ploidy Rate
Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups
Sustained Implantation Rates
The number of participants discharged at 8-9 weeks gestational age to their obstetrician.

Full Information

First Posted
May 4, 2023
Last Updated
September 20, 2023
Sponsor
IVI America
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1. Study Identification

Unique Protocol Identification Number
NCT05859152
Brief Title
Zona Pellucida Bound Sperm vs. Embryologist Selected Sperm for Intracytoplasmic Sperm Injection
Official Title
Comparing the Outcomes of Intracytoplasmic Sperm Injection (ICSI) Using the Zona Pellucida-Bound Sperm Versus Conventional Manually Selected Sperm
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Intracytoplasmic Sperm Injection Procedure, ICSI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ZP Bound Sperm Selection Oocyte Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care: Embryologist Selected Sperm Oocyte Cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Zona Pellucida-Bound Sperm Selection for ICSI
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Embryologist Selected Sperm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blastulation Rate
Description
Blastulation rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Time Frame
one week after the vaginal oocyte retrieval and ICSI procedure
Secondary Outcome Measure Information:
Title
Fertilization Rate
Description
fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
Time Frame
24 hours post ICSI procedure
Title
Blastocyst Ploidy Rate
Description
Preimplantation genetic testing for aneuploidy will be performed at the blastocyst stage and ploidy status compared between groups
Time Frame
Approximately 2 weeks after trophectoderm biopsy
Title
Sustained Implantation Rates
Description
The number of participants discharged at 8-9 weeks gestational age to their obstetrician.
Time Frame
Approximately 6 weeks after frozen embryo transfer procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Zuckerman, BS, RN
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine V Whitehead, BSN, RN
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
Facility Information:
Facility Name
Reproductive Medicine Associates of Northern California
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Zuckerman, BS, RN
Phone
973-656-2841
Email
clinicalresearchteam@ivirma.com
First Name & Middle Initial & Last Name & Degree
Christine V Whitehead
Phone
19736562841
Email
clinicalresearchteam@ivirma.com
First Name & Middle Initial & Last Name & Degree
Jonathan Kort, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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