- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122207
Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders. (PROFEC II)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susana Manzano Jiménez, PhD
- Phone Number: 918035179
- Email: susana.manzano@probisearch.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Couples or women with ages between 18 and 40 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Probiotic
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. |
|
Placebo Comparator: Placebo
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. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After 3 months of intervention.
|
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.
|
After 6 months of intervention.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of vaginal dysbiosis criteria in case of pregnancy confirmation.
Time Frame: Up to 6 months.
|
Up to 6 months.
|
Number of dysbiosis criteria per woman.
Time Frame: Before intervention.
|
Before intervention.
|
Number of dysbiosis criteria per woman.
Time Frame: After 3 months of treatment pregnancy confirmation.
|
After 3 months of treatment pregnancy confirmation.
|
Number of dysbiosis criteria per woman.
Time Frame: After 6 months of treatment or pregnancy confirmation.
|
After 6 months of treatment or pregnancy confirmation.
|
Percentage of Lactobacillus in vaginal microbiota.
Time Frame: Before intervention.
|
Before intervention.
|
Percentage of Lactobacillus in vaginal microbiota.
Time Frame: After 3 months of treatment or pregnancy confirmation.
|
After 3 months of treatment or pregnancy confirmation.
|
Percentage of Lactobacillus in vaginal microbiota.
Time Frame: After 6 months of treatment or pregnancy confirmation.
|
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.
|
After 6 months of treatment or pregnancy confirmation.
|
Pregnancy rate.
Time Frame: After 6 months of treatment or pregnancy confirmation.
|
After 6 months of treatment or pregnancy confirmation.
|
Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).
Time Frame: Up to 6 months.
|
Up to 6 months.
|
Miscarriage rate in the first trimester of pregnancy.
Time Frame: Before 12 weeks of pregnancy.
|
Before 12 weeks of pregnancy.
|
Number of oocytes extracted.
Time Frame: Before IVF cycle.
|
Before IVF cycle.
|
Embryo Quality (A, B or C).
Time Frame: Before IVF cycle.
|
Before IVF cycle.
|
Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.
Time Frame: Before IVF cycle.
|
Before IVF cycle.
|
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.
Time Frame: Before intervention.
|
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.
|
After 6 months of treatment or pregnancy confirmation.
|
Percentage (%) of women with vaginal dysbiosis.
Time Frame: Before intervention.
|
Before intervention.
|
Time elapsed from the beginning of the study, until the occurrence of pregnancy.
Time Frame: Up to 6 months.
|
Up to 6 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FEC/23.03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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