CompletedNot Applicable

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

Spain30 participantsStarted 2018-10-22

Plain-language summary

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.

Who can participate

Age range20 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples.

Timeframe: 7 months and a half

Trial details

NCT IDNCT03701893

SponsorProbiSearch SL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-31