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

ProbiSearch SL30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Infertility Vaginal Flora Imbalance Genital Disorder

Interventions

Lactobacillus PS11610DIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario La Paz

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 7 months and a half

Data from ClinicalTrials.gov

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