Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders. (PROFEC II)

ProbiSearch

Status: Enrolling

Conditions: Fertility Disorders

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122207

FEC/23.03

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo