Genital Disorder, Infertility, Vaginal Flora Imbalance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus 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.
Sponsors
ProbiSearch SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Open label intervention study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Counts of microorganisms presents in cultured samples of genital tracts obtained from infertility couples. | 7 months and a half | The microbial composition obtained by culture of genital tracts samples from couples with infertility |
Countries
Spain
Outcome results
None listed