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

NCT ID: NCT03701893

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-22
• Study Completion Date: 2019-12-31

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.

Conditions

Infertility; Vaginal Flora Imbalance; Genital Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Lactobacillus PS11610

Intervention Type: 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.

Interventions

Lactobacillus PS11610

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ProbiSearch SL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susana Manzano, PhD

Role: STUDY_CHAIR

ProbiSearch SL

Locations

Hospital Universitario La Paz

Madrid, , Spain

Countries

Spain

Other Identifiers

FEC/18.01

Identifier Type: -

Identifier Source: org_study_id