CompletedPhase 2

Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin

Spain58 participantsStarted 2018-10-16

Plain-language summary

In this study, we aimed to assess the cervicovaginal environment (pH, Nugent score, soluble immune factors and bacterial profile) in women with reproductive failure because of either repetitive abortion or infertility of unknown origin and compare it to that of healthy fertile women. The second objective was to evaluate the ability of Lactobacillus salivarius CECT5713 to modulate such parameters and to increase pregnancy rates in women with reproductive failure. The administration of L. salivarius CECT5713 (\~9 log10 colony-forming units (CFU)/day) for 6 months or until a diagnosis of pregnancy to women with reproductive failure resulted in an overall successful (term) pregnancy rate of 56%.

Who can participate

Age range33 Years – 41 Years

SexFEMALE

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Inclusion Criteria: * Recurrent miscarriage with three or more pregnancy losses during the first 12 weeks of pregnancy (RA group) * Infertility (inability to conceive) despite being the recipients of ART for at least three times, including two cycles, at least, of in vitro fertilization (IVF) (INF group). * Fertile women having at least two children after uncomplicated term pregnancies (Control group). Exclusion Criteria: * Antiphospholipid syndrome * Hormonal therapy, antibiotics or probiotics in the 4 weeks previous to sampling. * Lactose intolerance or cow's milk protein allergy (RA and INF groups)

What they're measuring

Pregnancies and successful pregnancies

Timeframe: 6 months

Trial details

NCT IDNCT04446572

SponsorUniversidad Complutense de Madrid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-29

View on ClinicalTrials.gov More Abortion, Spontaneous trials