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

ProbiSearch

Status: Completed

Conditions: Infertility; Vaginal Flora Imbalance; Genital Disorder

Treatments: Dietary Supplement: Lactobacillus PS11610

Study type: Interventional

Funder types: Industry

Identifiers

NCT03701893

FEC/18.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Lactobacillus PS11610

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Lactobacillus PS11610