ProVag - The effect of oral probiotics intake on the vaginal microbiota compositio

• Conditions: low microbiome profile; Subfertility; 10038612

• Registration Number: NL-OMON56325
• Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 110

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will collect vaginal and rectal swabs at enrolment and at the end of the<br /><br>treatment (after 8 weeks). The main study parameters is determination of the<br /><br>vaginal and gut microbiota using the inter spacer bacterial profiling (ISpro)<br /><br>technique.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Microbiome profile in the vaginal swabs and gut microbiota in in rectal<br /><br>samples<br /><br>- Pregnancy rate and (time to pregnancy after inclusion, vital pregnancy at 7<br /><br>weeks of gestation, pregnancy loss, live birth rate) during a 1 year follow-up<br /><br>period<br /><br>- Vaginal pH<br /><br>- Microbiome profile determination after 4 and 6 weeks of treatment</p><br>