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

Not Applicable

Completed

• Conditions: Infertility; Vaginal Flora Imbalance; Genital Disorder
• Interventions: Dietary Supplement: Lactobacillus PS11610

• Registration Number: NCT03701893
• Lead Sponsor: ProbiSearch SL

Brief 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.

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 Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-10
• Study Start: 2018-10-22
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactobacillus PS11610	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain