Status:
COMPLETED
Application of Lactobacillus Salivarius CECT5713 in Infertility of Unknown Origin
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Bisearch Life
Centro de Diagnóstico Médico. Ayuntamiento de Madrid.
Conditions:
Abortion, Spontaneous
Abortion in First Trimester
Eligibility:
FEMALE
33-41 years
Phase:
PHASE2
Brief 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 aborti...
Detailed Description
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 aborti...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04446572
Start Date
October 16 2018
End Date
November 29 2019
Last Update
June 26 2020
Active Locations (1)
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1
Dpt. Nutricion, Bromatologia y Tecnologia de los Alimentos
Madrid, Spain, 28040