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

April 17, 2024 updated by: IVI America

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ZP Bound Sperm Selection Oocyte Cohort
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
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 Care: Embryologist Selected Sperm Oocyte Cohort
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastulation Rate
Time Frame: one week after the vaginal oocyte retrieval and ICSI procedure
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
Blastocyst Ploidy Rate
Time Frame: Approximately 2 weeks after trophectoderm biopsy
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
Time Frame: Approximately 6 weeks after frozen embryo transfer procedure
The number of participants discharged at 8-9 weeks gestational age to their obstetrician.
Approximately 6 weeks after frozen embryo transfer procedure
Fertilization Rate
Time Frame: 24 hours post ICSI procedure
fertilization rates per mature oocyte of ZP-bound versus embryologist selected sperm after ICSI.
24 hours post ICSI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVIRMA-NorCal-Z01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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