Evaluate the Use of a New Probiotic Strain in Couples With Fertility Problems and Dysbiosis. (PROFEC)

Evaluate the Effect of the Strain Lactobacillus PS11610 on the Microbiota of the Female and Male Genital Tract in Couples With Fertility Problems and Dysbiosis.

Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Study Overview

• Status: Completed
• Conditions: Infertility; Vaginal Flora Imbalance; Genital Disorder
• Intervention / Treatment: Dietary supplement: Lactobacillus PS11610

Detailed Description

Pilot study to evaluate the effect of the strain Lactobacillus PS11610 on the microbiota of the female and male genital tract in couples with fertility problems. Couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. The estimated duration of the study will be 7 and a half months.

Four visits are included in the study period.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Couples with ages between 20 and 40
• Couples under an assisted reproduction treatment: Artificial Insemination or In vitro Fertilization.
• Signature of informed consent

Exclusion Criteria:

• Anovulation
• Hyperprolactinemia
• Hypogonadotropic hypergonadism
• Hypergonadotropic Hypergonadism
• Hyperandrogenisms
• Polycystic ovary syndrome
• Endometriosis
• Pelvic adhesions
• Myomas, polyps and / or uterine synechia
• Diagnosis of tubal factor (hydrosalpinx, tubal obstructions)
• Low ovarian reserve
• Azoospermia
• Sperm motility (A + B) <25%
• Sperm morphology ≤2%
• With chronic diseases that cause intestinal malabsorption
• With known congenital or acquired immunodeficiency.
• Obesity (IMC ≥ 30)
• Current history or diagnosis of alcohol, tobacco and drug abuse
• Uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lactobacillus PS11610; Lactobacillus PS11610 for couples with genital dysbiosis and infertility. Each dose contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610.Two daily doses for her and one daily dose for him until pregnancy or end of study period (6 months).

Dietary supplement: Lactobacillus PS11610; 7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.	The microbial composition obtained by culture of genital tracts samples from couples with infertility	7 months and a half

Collaborators and Investigators

• Sponsor: ProbiSearch SL

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infertility; Dysbiosis
• Other Study ID Numbers: FEC/18.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No