The goal of this study is to elucidate whether oral probiotic treatment change the VMB profile of IVF patients score from Low to Medium/High (based on the ReceptIVFity test), compared to a placebo treatment
ID
Source
Brief title
Condition
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will collect vaginal and rectal swabs at enrolment and at the end of the
treatment (after 8 weeks). The main study parameters is determination of the
vaginal and gut microbiota using the inter spacer bacterial profiling (ISpro)
technique.
Secondary outcome
- Microbiome profile in the vaginal swabs and gut microbiota in in rectal
samples
- Pregnancy rate and (time to pregnancy after inclusion, vital pregnancy at 7
weeks of gestation, pregnancy loss, live birth rate) during a 1 year follow-up
period
- Vaginal pH
- Microbiome profile determination after 4 and 6 weeks of treatment
Background summary
Abnormality of the vaginal microbiota (VMB) has been linked to different
conditions associated with fertility and contributing to unsuccessful In Vitro
Fertilization (IVF) treatment. Innovations in assisted reproduction
technologies offer the possibility to monitor VMB profiles in IVF patients in
order to identify the best window for IVF treatment and embryo transfer. One
such innovation is the ReceptIVFity test. This is a predictive test that
assesses the chances of becoming pregnant in women undergoing IVF treatment
based on the VMB composition. The test can result in a High, Medium or Low
vaginal profile score. With a High score, the chance of pregnancy following IVF
treatment is 52.6%. With a Medium score, the chance is 23.6% which is
approximately the normal chance of becoming pregnant after IVF. And a Low
score predicts a pregnancy chance of 5.9%. The data suggest that the prevalence
of a Low profile among IVF patients is around 30-35%, with profiles naturally
switching from Low to Medium or High. Yet, to date limited evidence is
available on the effect of active modification strategy to facilitate the
modulation from Low to Medium/High profiles in patients undergoing IVF
treatment.
Among such patients, opportunities to improve VMB Low profiles could help
restore a profile dominated by Lactobacillus species that is supportive for
implantation and subsequent pregnancy, ultimately assisting and empowering
patients in their journey of having a child.
Study objective
The goal of this study is to elucidate whether oral probiotic treatment change
the VMB profile of IVF patients score from Low to Medium/High (based on the
ReceptIVFity test), compared to a placebo treatment
Study design
This is a randomized, placebo-controlled, double-blind intervention designed as
a proof-of-principle.
Intervention
Participants will randomly receive probiotic or placebo treatment for 8 weeks.
Study burden and risks
Participants are invited for 4 extra visits to the MUMC+ for collection of
vaginal and rectal swabs, and will receive probiotic/placebo treatment. The
risks of probiotic treatment are low and no serious adverse events have been
reported using them, but only minor gastrointestinal complaints such as
bloating or flatulence.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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
- 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
- Pregnant 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81210.068.22 |