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NCT Number: NCT06122207

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

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Key information

Conditions

Fertility Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Miguel Raimundo (Portugal), Lisbon, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement
  • Women: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) every 12 hours for 6-months. In case of pregnancy:
  • Women: 1 capsule of probiotic per day for 12 weeks.
  • Men: 1 capsule of probiotic (Ligilactobacillus salivarius PS11610) per day for 6-months.

Placebo

Dietary Supplement
  • Women: 1 capsule of placebo every 12 hours for 6-months. In case of pregnancy:
  • Women:1 capsule of placebo per day for 12 weeks.
  • Men: 1 capsule of placebo per day for 6-months.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of vaginal dysbiosis criteria in case of pregnancy confirmation.

    Time frame: Up to 6 months.

  2. Percentage (%) of women with vaginal dysbiosis.

    Time frame: Before intervention.

  3. Number of dysbiosis criteria per woman.

    Time frame: Before intervention.

  4. Number of dysbiosis criteria per woman.

    Time frame: After 3 months of treatment pregnancy confirmation.

  5. Number of dysbiosis criteria per woman.

    Time frame: After 6 months of treatment or pregnancy confirmation.

  6. Percentage of Lactobacillus in vaginal microbiota.

    Time frame: Before intervention.

  7. Percentage of Lactobacillus in vaginal microbiota.

    Time frame: After 3 months of treatment or pregnancy confirmation.

  8. Percentage of Lactobacillus in vaginal microbiota.

    Time frame: After 6 months of treatment or pregnancy confirmation.

  9. Number of reproductive treatments during the study period.

    Time frame: After 6 months of treatment or pregnancy confirmation.

  10. Pregnancy rate.

    Time frame: After 6 months of treatment or pregnancy confirmation.

  11. Time elapsed from the beginning of the study, until the occurrence of pregnancy.

    Time frame: Up to 6 months.

  12. Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).

    Time frame: Up to 6 months.

  13. Miscarriage rate in the first trimester of pregnancy.

    Time frame: Before 12 weeks of pregnancy.

  14. Number of oocytes extracted.

    Time frame: Before IVF cycle.

  15. Embryo Quality (A, B or C).

    Time frame: Before IVF cycle.

  16. Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.

    Time frame: Before IVF cycle.

  17. Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.

    Time frame: Before intervention.

  18. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susana Manzano Jiménez, PhD

CONTACT

[email protected]

918035179

Sponsors and collaborators

Lead sponsor

ProbiSearch SL

Industry

Registry information

Official study title

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.

Acronym: PROFEC II

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 8, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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