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

NCT03701893 | Completed

• 1 other identifier: FEC/18.01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Vaginal Flora Imbalance; Genital Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lactobacillus PS11610

EXPERIMENTAL

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

Interventions

Lactobacillus PS11610 DIETARY_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.

Lactobacillus PS11610

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProbiSearch SL: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Susana Manzano, PhD

  ProbiSearch SL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label intervention study.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 10, 2018
• Study Start: October 22, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

ES (1)