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New sperm device aims to improve embryo development in IVF

NCT ID NCT05680363

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested a new device called HyperSperm that prepares sperm for IVF or ICSI. Researchers compared it to standard sperm preparation in 41 couples. The goal was to see if the new method leads to more embryos reaching the blastocyst stage, which is key for successful implantation.

What this could mean

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

Active substance
HyperSperm device
What this could lead to
If it works, this could improve the chances of creating healthy embryos for IVF, potentially helping more couples have a baby.
What could go wrong
This was a small, early-stage trial with only 41 participants. The results may not apply to everyone, and the device may not significantly improve outcomes over standard methods.

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

41 people

The number who actually took part.

Started

May 2023

Finished

Dec 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

20 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.

Female: Inclusion Criteria: * With ovarian reserve of between 8 and 30 antral follicles counting both ovaries * Treatment planned for embryo transfer at the blastocyst stage Exclusion Criteria: * Any diagnosed sexually transmitted infection (STI) * Diabetes or other metabolic disorders. * Recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth). * Previous failures in two or more IVF cycles Male: Inclusion Criteria for IVF: * Age: 20-55 years * Fresh sample (not cryopreserved ) * Sperm motility (TOTAL) ≥ 40% in spermogram * Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram * Sperm count after swim up ≥ 5x10\^6 * Treatment planned for embryo transfer at the blastocyst stage Inclusion Criteria for ICSI: * Age: 20-55 years * Fresh sample (not cryopreserved ) * Sperm concentration ≥ 10x10\^6 /ml in spermogram * Sperm motility (TOTAL) ≥ 20% in spermogram * Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram * Treatment planned for embryo transfer at the blastocyst stage Exclusion Criteria: * Any diagnosed sexually transmitted infection (STI) * Total failure of in vitro fertilization in previous cycles.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Fertya

    Rosario, Santa Fe Province, 2282, Argentina

  • In Vitro Buenos Aires

    Buenos Aires, Buenos Aires F.D., 1058, Argentina

  • Pregna

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

  • WeFIV

    Buenos Aires, Buenos Aires F.D., 1428, Argentina

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