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New sperm selection method tested for IVF success

NCT ID NCT05859152

Knowledge-focused Sponsor: IVI America Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new way to select sperm for IVF. Instead of an embryologist picking the best-looking sperm, they used sperm that naturally attached to the outer layer of an immature egg. The goal was to see if this method leads to more embryos developing into blastocysts. The study involved 29 couples undergoing their first IVF cycle.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zona Pellucida-Bound Sperm Selection for ICSI
What this could lead to
If this method works, it could improve embryo quality and success rates for IVF patients.
What could go wrong
This is a small, early-stage study with only 29 participants. The new method may not be better than the standard approach, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

29 people

The number who actually took part.

Started

Nov 2023

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 41 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility

Contacts and locations

Locations

  • Reproductive Medicine Associates of Northern California

    San Francisco, California, 94105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.