RECRUITING

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

Conditions

Infertility Intracytoplasmic Sperm Injection Procedure ICSI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-03

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05859152

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.

Ages Eligible for Study:18 Years to 41 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Caroline Zuckerman, BS, RN

CONTACT

19736562841

clinicalresearchteam@ivirma.com

Christine V Whitehead, BSN, RN

CONTACT

19736562841

clinicalresearchteam@ivirma.com

Study Locations (Sites)

Reproductive Medicine Associates of Northern California

San Francisco, California, 94105

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-11-03

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-11-03

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Intracytoplasmic Sperm Injection Procedure
ICSI

Additional Relevant MeSH Terms

Infertility