Probiotic treatment for women with fertility disorders
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.
NA · ProbiSearch SL · NCT06122207
This study is testing whether a probiotic called Fertibiome® can help improve fertility for women and couples dealing with fertility issues by restoring a healthy vaginal microbiome.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | ProbiSearch SL (industry) |
| Locations | 2 sites (Lisbon and 1 other locations) |
| Trial ID | NCT06122207 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of the probiotic product Fertibiome® on the vaginal microbiota of women and couples experiencing fertility disorders. It is a randomized, double-blind, placebo-controlled trial that aims to determine whether restoring a healthy vaginal microbiome can improve fertility outcomes. Participants will take the probiotic or a placebo for approximately six months, with the study focusing on those undergoing assisted reproductive treatments. The research is based on the premise that a healthy urogenital microbiome can enhance implantation rates and pregnancy success.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 40 and men aged 18 to 55 who are experiencing fertility disorders and are undergoing or planning to undergo IVF treatment.
Not a fit: Patients who do not have a fertility diagnosis or those with significant chronic health issues or high BMI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve fertility outcomes for women with dysbiosis and enhance the effectiveness of assisted reproductive treatments.
How similar studies have performed: Previous studies have indicated positive outcomes with probiotic treatments for restoring vaginal microbiota, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lisbon and 1 other locations
- Dr. Miguel Raimundo (Portugal) — Lisbon, Portugal (RECRUITING)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Susana Manzano Jiménez, PhD
- Email: susana.manzano@probisearch.com
- Phone: 918035179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fertility Disorders