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

Infertility Clinical Trial

— PROFEC  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701893
• Other study ID #: FEC/18.01
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: ProbiSearch SL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Genital Disorder
• Infertility
• Vaginal Flora Imbalance

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
ProbiSearch SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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