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

Fertility Disorders Clinical Trial

— PROFEC II  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122207
• Other study ID #: FEC/23.03
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: ProbiSearch SL
• Contact: Susana Manzano Jiménez, PhD
• Phone: 918035179
• Email: susana.manzano[@]probisearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Dietary Supplement:
• Probiotic
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
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.

Locations

Country	Name	City	State
Portugal	Dr. Miguel Raimundo (Portugal)	Lisboa
Spain	Hospital Universitario La Paz	Madrid	Comunidad De Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ProbiSearch SL

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of women with vaginal dysbiosis after 3 months of treatment.	The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.	After 3 months of intervention.
Primary	Percentage (%) of women with vaginal dysbiosis after 6 months of treatment.	The percentage of vaginal dysbiosis confirmed will be compared between groups of treatment.	After 6 months of intervention.
Secondary	Number of vaginal dysbiosis criteria in case of pregnancy confirmation.		Up to 6 months.
Secondary	Percentage (%) of women with vaginal dysbiosis.		Before intervention.
Secondary	Number of dysbiosis criteria per woman.		Before intervention.
Secondary	Number of dysbiosis criteria per woman.		After 3 months of treatment pregnancy confirmation.
Secondary	Number of dysbiosis criteria per woman.		After 6 months of treatment or pregnancy confirmation.
Secondary	Percentage of Lactobacillus in vaginal microbiota.		Before intervention.
Secondary	Percentage of Lactobacillus in vaginal microbiota.		After 3 months of treatment or pregnancy confirmation.
Secondary	Percentage of Lactobacillus in vaginal microbiota.		After 6 months of treatment or pregnancy confirmation.
Secondary	Number of reproductive treatments during the study period.		After 6 months of treatment or pregnancy confirmation.
Secondary	Pregnancy rate.		After 6 months of treatment or pregnancy confirmation.
Secondary	Time elapsed from the beginning of the study, until the occurrence of pregnancy.		Up to 6 months.
Secondary	Spontaneous pregnancy rate, not associated to fertility treatment (IVF or AI).		Up to 6 months.
Secondary	Miscarriage rate in the first trimester of pregnancy.		Before 12 weeks of pregnancy.
Secondary	Number of oocytes extracted.		Before IVF cycle.
Secondary	Embryo Quality (A, B or C).		Before IVF cycle.
Secondary	Number of vaginal dysbiosis criteria at the time of embryo transfer per IVF cycle.		Before IVF cycle.
Secondary	Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.		Before intervention.
Secondary	Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood plasma of women.		After 6 months of treatment or pregnancy confirmation.