NCT05859152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

November 3, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

May 4, 2023

Last Update Submit

January 19, 2026

Conditions

Infertility

Keywords

Intracytoplasmic Sperm Injection ProcedureICSI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Fertilization Rate

    24 hours post ICSI procedure

  • Blastocyst Ploidy Rate

    Approximately 2 weeks after trophectoderm biopsy

  • Sustained Implantation Rates

    Approximately 6 weeks after frozen embryo transfer procedure

Study Arms (2)

ZP Bound Sperm Selection Oocyte Cohort

EXPERIMENTAL

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

Routine Care: Embryologist Selected Sperm Oocyte Cohort

OTHER

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

Interventions

Routine Embryologist Selected SpermOTHER

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.

Routine Care: Embryologist Selected Sperm Oocyte Cohort
Zona Pellucida-Bound Sperm Selection for ICSIOTHER

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.

ZP Bound Sperm Selection Oocyte Cohort

Eligibility Criteria

Age18 Years - 41 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of Northern California

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

November 3, 2023

Primary Completion

December 2, 2024

Study Completion

September 14, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)