Probiotic treatment for women with fertility disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.