Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.

Launched by PROBISEARCH SL · Nov 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a specific probiotic called Fertibiome® may help improve the vaginal microbiota in women who have fertility disorders. A healthy balance of microorganisms in the vaginal area is important for better chances of pregnancy, especially for those undergoing assisted reproductive treatments like IVF. The trial will involve couples or women aged 18 to 40 who are facing fertility challenges and are either currently in IVF treatment or planning to start it.

Participants will be assigned to one of two groups: one group will receive the probiotic, while the other group will receive a placebo, which looks the same but contains no active ingredients. Women will take one capsule every 12 hours, and men will take one capsule daily. The study will last about six months, and if a woman becomes pregnant during the trial, she will continue to take the probiotic for the first 12 weeks of her pregnancy. This trial aims to see if taking the probiotic can lead to a healthier vaginal microbiome and improve fertility outcomes. It's important to note that certain health conditions may exclude individuals from participation, so potential participants should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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.