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Could a probiotic boost fertility? new study investigates

NCT ID NCT06122207

Disease control Sponsor: ProbiSearch SL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether a probiotic called Fertibiome can help restore a healthy balance of bacteria in the vagina for women or couples having trouble getting pregnant. About 120 participants will take either the probiotic or a placebo for up to 6 months. The goal is to see if the probiotic reduces vaginal dysbiosis, which is linked to better pregnancy outcomes.

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 120 people

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

Started

Feb 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 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: * Couples or women with ages between 18 and 45 for woman and between 18 and 55 for man (in case of couple participation). * Couples or women with fertility disorders. * Couples or women undergoing IVF treatment or willing to start it. * Signature of the Informed Consent. Exclusion Criteria: * Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy. * Women with Body Mass Index (BMI) ≥ 30. * Couples where the woman has not infertility diagnosis while the man has any of the following characteristics: * Azoospermia * Sperm motility (A + B) \< 25%. * Sperm morphology ≤ 2%. * Vas deferens obstruction. * Couples or women with any of the following characteristics: * Chronic diseases that cause intestinal malabsortion. * Congenital or acquired immunodeficiency. * Current history or diagnosis of alcohol, tobacco, or drug abuse. * Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol. * Under treatment with probiotics during the last week.

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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.

Fertility disorders

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 in 2 countries. 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

  • Dr. Miguel Raimundo (Portugal)

    RECRUITING

    Lisbon, Portugal

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, 28046, Spain

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