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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Infertility, Vaginal Flora Imbalance, Genital Disorder

Intervention / Treatment
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* Dietary Supplement: Lactobacillus PS11610


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Open label intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus PS11610<br>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<br>* 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.<br>|

What is the study measuring?
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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 |