Subfertility, low vaginal microbiome profile Subfertility, low vaginal microbiome profile
Conditions
Interventions
Participants will randomly receive probiotic or placebo treatment for 8 weeks.
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 18 - 43 years - Primary or secondary infertility with a IVF indication - Non-smoker - Low* VMB profile, as measured by the ReceptIVFity score - Signed informed consent * Definition of ReceptIVFity Low profile (Koedooder R 2019): - Relative Lactobacillus load <20% and/or - Relative L. jensenii load >35% and/or - Presence of G. vaginalis IST1 and/or - Relative Proteobacteria load >28%
Exclusion criteria
Exclusion criteria: - Use of oral/vaginal antibiotics during the 6 weeks before (and up to) enrolment. Antibiotics use during the study does not lead to exclusion, but will be monitored during follow-up visits. - Use of other oral or vaginal probiotics at enrolment and during the study - Use of hormonal treatment other than the IVF course - Pregnancy at enrolment - Genital symptoms at enrolment - With history of adverse reaction/allergy to any of the content in the probiotic or placebo - Serious illnesses, hospitalized (or recently hospitalized) or immune compromised, specified to: usage of immune suppressants, immune deficiency disorders and disorders with a disrupted intestinal barrier - Undergoing Pre-implantation Genetic Testing (PGT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will collect vaginal and rectal swabs at enrolment and at the end of the treatment (after 8 weeks). The main study parameter is to investigate whether oral probiotic treatment changes the VMB profile score of IVF patients from low to medium/high, measured by the ReceptIVFity test, more often compared to a placebo treatment after 8 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Can bacterial strains in the oral probiotic treatment be detected in the vaginal tract and/or in the gut? - Can changes in the microbiome be seen already after 4 and 6 weeks of treatment, and how does this relate to the placebo treatment group? - Does oral probiotic treatment lead to a beneficial low (< 4.5) vaginal pH? - Does oral probiotic treatment lead to increased ongoing pregnancy rates after IVF, compared to rates among placebo and IVF patients in the same centre? | — |
Countries
Netherlands
Contacts
Public ContactLBPM Stevens Brentjens
Maastricht Universitair Medisch Centrum +
Outcome results
None listed