Evaluate the Use of a New Probiotic Str… | Clinical Trial

Key information

Conditions

Infertility Genital Diseases Genital Disorder Urogenital Diseases Vaginal Flora Imbalance

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: 7 months and a half

The microbial composition obtained by culture of genital tracts samples from couples with infertility

Sponsors and collaborators

Lead sponsor

ProbiSearch SL

Industry

Registry information

Official study 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.

Acronym: PROFEC

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Oct 10, 2018
Registry last updated: Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed