Infertility Unexplained
Conditions
Keywords
Infertility
Brief summary
The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation.
Interventions
DIETARY_SUPPLEMENTLigilactobacillus salivarius CECT5713
Oral administration of a capsule containing 9.5 log10 cfu of the strain.
DIETARY_SUPPLEMENTPlacebo
Oral administration of a capsule containing maltodextrin.
Sponsors
Hospital San Carlos, Madrid
Universidad Complutense de Madrid
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator.
Intervention model description
Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with \ 50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with \ 50 mg of maltodextrin.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* legal age * Intention to achieve a pregnancy, but without achieving it; * Be willing to undergo in vitro fertilization treatment; * Be on the waiting list for the IVF cycle with an expected waiting time \> 5 months.
Exclusion criteria
* Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...). * Genitourinary malformations; * Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...). * Treatment/intervention other than the planned IVF after the start date of the intervention. * Antibiotic treatment at the start date of the intervention. * Intention to consume another probiotic supplement in the following 3 months. * Participation in another clinical trial. * Allergic/intolerant to the excipient. * Inability to understand the informed consent form and/or to follow the basic instructions of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful pregnancies | 9 months | Total number of pregnancies with delivery of a healthy baby |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modification of the vaginal microbiota | 9 months | Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces) |
| Vaginal immunomodulation | 9 months | Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, RANTES, TGF-β1, 2 and 3, VEGF, GRO-alpha and TNF-alpha) |
Countries
Spain
Outcome results
None listed