Status:
RECRUITING
Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.
Lead Sponsor:
ProbiSearch SL
Conditions:
Fertility Disorders
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent th...
Eligibility Criteria
Inclusion
- Couples or women with ages between 18 and 40 for woman and between 18 and 55 for man (in case of couple participation).
- Couples or women with fertility disorders.
- Couples or women undergoing IVF treatment or willing to start it.
- Signature of the Informed Consent.
Exclusion
- Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.
- Women with Body Mass Index (BMI) ≥ 30.
- Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:
- Azoospermia
- Sperm motility (A + B) \< 25%.
- Sperm morphology ≤ 2%.
- Vas deferens obstruction.
- Couples or women with any of the following characteristics:
- Chronic diseases that cause intestinal malabsortion.
- Congenital or acquired immunodeficiency.
- Current history or diagnosis of alcohol, tobacco, or drug abuse.
- Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.
- Under treatment with probiotics during the last week.
Key Trial Info
Start Date :
February 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06122207
Start Date
February 14 2024
End Date
October 1 2025
Last Update
June 3 2025
Active Locations (2)
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1
Dr. Miguel Raimundo (Portugal)
Lisbon, Portugal
2
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046