Fertility DisordersPROFEC IINCT06122207
Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.
A study testing Probiotic in people with Fertility Disorders, run by ProbiSearch SL at 2 sites in 2 countries.
Trial summary
In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Feb 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Portugal1 site, 1 recruiting
- Recruiting
Dr. Miguel Raimundo (Portugal)
Lisbon
Miguel Raimundo, MD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Silvia Iniesta Pérez, MD, PhD
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Confirm the Positive Effect of Fertibiome® (Ligilactobacillus Salivarius PS11610) on the Female Genital Tract Microbiota of Couples or Women With Fertility Disorders.
In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).
Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.
Read more
An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.
The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.
- Conditions
- Fertility Disorders
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
- Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy:
- Women: 1 capsule of probiotic per day for 12 weeks.
- Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months.
PlaceboDietary supplement
- Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy:
- Women:1 capsule of placebo per day for 12 weeks.
- Men: 1 capsule of placebo per day for 6-months.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Women will take two daily doses containing approximately 2*10E9 Colony Forming Unit (CFU) of Ligilactobacillus salivarius PS11610 (Fertibiome®). Men will take one daily dose containing approximately 1*10E9 CFU of Ligilactobacillus salivarius PS11610 (Fertibiome®).
In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Women will take two daily doses of Placebo supplement. Men will take one daily dose of Placebo supplement.
In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
Measured: After 3 months of intervention.
Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
Measured: After 6 months of intervention.
Secondary outcomes (18)
Number of vaginal dysbiosis criteria in case of pregnancy confirmation.
Measured: Up to 6 months.
Percentage (%) of women with vaginal dysbiosis.
Measured: Before intervention.
Number of dysbiosis criteria per woman.
Measured: Before intervention.
Number of dysbiosis criteria per woman.
Measured: After 3 months of treatment pregnancy confirmation.
Number of dysbiosis criteria per woman.
Measured: After 6 months of treatment or pregnancy confirmation.
Percentage of Lactobacillus in vaginal microbiota.
Measured: Before intervention.
Percentage of Lactobacillus in vaginal microbiota.
Measured: After 3 months of treatment or pregnancy confirmation.
Percentage of Lactobacillus in vaginal microbiota.
Measured: After 6 months of treatment or pregnancy confirmation.
Number of reproductive treatments during the study period.
Measured: After 6 months of treatment or pregnancy confirmation.
Pregnancy rate.
Measured: After 6 months of treatment or pregnancy confirmation.
Time elapsed from the beginning of the study, until the occurrence of pregnancy.
Measured: Up to 6 months.
Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).
Measured: Up to 6 months.
Miscarriage rate in the first trimester of pregnancy.
Measured: Before 12 weeks of pregnancy.
Number of oocytes extracted.
Measured: Before IVF cycle.
Embryo Quality (A, B or C).
Measured: Before IVF cycle.
Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.
Measured: Before IVF cycle.
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.
Measured: Before intervention.
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.
Measured: After 6 months of treatment or pregnancy confirmation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start14 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122207
- Sponsor's protocol ID
- FEC/23.03
- Acronym
- PROFEC II
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Confirm the Positive Effect of Fertibiome® (Ligilactobacillus Salivarius PS11610) on the Female Genital Tract Microbiota of Couples or Women With Fertility Disorders.
- ClinicalTrials.gov ID
- NCT06122207
- Acronym / sponsor ID
- PROFEC II / FEC/23.03
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).
Infertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.
The duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.
Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticWomen will take two daily doses containing approximately 2*10E9 Colony Forming Unit (CFU) of Ligilactobacillus salivarius PS11610 (Fertibiome®). Men will take one daily dose containing approximately 1*10E9 CFU of Ligilactobacillus salivarius PS11610 (Fertibiome®). In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboWomen will take two daily doses of Placebo supplement. Men will take one daily dose of Placebo supplement. In case of pregnancy during intervention, only women will continue taking 1 daily dose for the first 12 weeks of gestation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- Couples or women with any of the following characteristics:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic* Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy: * Women: 1 capsule of probiotic per day for 12 weeks. * Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months. | Dietary supplement | Probiotic |
| Placebo* Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy: * Women:1 capsule of placebo per day for 12 weeks. * Men: 1 capsule of placebo per day for 6-months. | Dietary supplement | Placebo |
Primary outcome
Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.
Time frame: After 3 months of intervention.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.
Time frame: After 6 months of intervention.
The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.
18 secondary outcomes
Number of vaginal dysbiosis criteria in case of pregnancy confirmation.
Time frame: Up to 6 months.
Percentage (%) of women with vaginal dysbiosis.
Time frame: Before intervention.
Number of dysbiosis criteria per woman.
Time frame: Before intervention.
Number of dysbiosis criteria per woman.
Time frame: After 3 months of treatment pregnancy confirmation.
Number of dysbiosis criteria per woman.
Time frame: After 6 months of treatment or pregnancy confirmation.
Percentage of Lactobacillus in vaginal microbiota.
Time frame: Before intervention.
Percentage of Lactobacillus in vaginal microbiota.
Time frame: After 3 months of treatment or pregnancy confirmation.
Percentage of Lactobacillus in vaginal microbiota.
Time frame: After 6 months of treatment or pregnancy confirmation.
Number of reproductive treatments during the study period.
Time frame: After 6 months of treatment or pregnancy confirmation.
Pregnancy rate.
Time frame: After 6 months of treatment or pregnancy confirmation.
Time elapsed from the beginning of the study, until the occurrence of pregnancy.
Time frame: Up to 6 months.
Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).
Time frame: Up to 6 months.
Miscarriage rate in the first trimester of pregnancy.
Time frame: Before 12 weeks of pregnancy.
Number of oocytes extracted.
Time frame: Before IVF cycle.
Embryo Quality (A, B or C).
Time frame: Before IVF cycle.
Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.
Time frame: Before IVF cycle.
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.
Time frame: Before intervention.
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.
Time frame: After 6 months of treatment or pregnancy confirmation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Fertility Disorders, run by ProbiSearch SL at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Manzano Jiménez, PhD (918035179, susana.manzano@probisearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of women with vaginal dysbiosis after 3 months of treatment. (time frame: After 3 months of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.