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New sperm prep method aims to boost IVF success

NCT ID NCT07478549

Disease control Sponsor: Fecundis Lab SL 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new way to prepare sperm for in vitro fertilization (IVF) called HyperSperm. It compares the safety and effectiveness of this method to standard sperm preparation. The trial will involve 202 couples undergoing IVF and will measure how many embryos are healthy (euploid), pregnancy rates, and fertilization success. The goal is to see if the new method leads to better outcomes without added risks.

What this could mean

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

Active substance
HyperSperm sperm preparation procedure
What this could lead to
If successful, this could lead to a safer, more effective sperm preparation method for IVF, potentially increasing the chance of healthy embryos and pregnancies.
What could go wrong
This is an early-stage safety trial, so the new method may not improve outcomes or could have unforeseen risks. Results may not apply to all fertility cases.

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

About 202 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

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

20 to 45 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: General * Couples undergoing in vitro fertilization (IVF) treatment. * Planned use of fresh sperm samples obtained by masturbation. Female * Age between 20 and 42 years. * Antral follicle count ≥ 4. * Eligible for ovarian stimulation and embryo transfer. Male * Age between 20 and 45 years. * Fresh semen sample (not cryopreserved). * Pre-processing sperm concentration ≥ 5 × 10⁶ sperm/mL. Exclusion Criteria: General * Active sexually transmitted infection (STI). * Use of donor sperm. * Medical conditions contraindicating pregnancy or the IVF procedure. Female * Uterine anomalies associated with distortion of the uterine cavity. * Absence of one ovary or functional disorders preventing ovulation. * Diabetes mellitus or other metabolic disorders. * Recurrent pregnancy loss, defined as more than two clinical pregnancies without live birth. Male \- Any medical condition affecting semen quality that, in the investigator's opinion, may interfere with study participation.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IFER

    Buenos Aires, Buenos Aires F.D., 1115, Argentina

  • Pregna

    Buenos Aires, Buenos Aires F.D., 1425, Argentina

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