Status:
COMPLETED
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Lead Sponsor:
Fertypharm
Conditions:
Infertility, Female
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-38 years
Phase:
NA
Brief Summary
The aim of the study is to study the effect of an antioxidant food supplement associated with probiotics on the oocyte quality response, oxidative stress and microbiota function in an in vitro fertili...
Detailed Description
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will be randomized in a double-blind manner in a ratio 1:1 to receive th...
Eligibility Criteria
Inclusion
- Age:18-38 years old
- Diagnosis of PCOS according to compliance with the Rotterdam criteria
- BMI \>= 25
Exclusion
- Hormonal contraceptive, insulin sensitizers such as metformin, inositols, antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugs or others with anti-inflammatory properties, antibiotics, probiotics, laxatives use in the 3 months prior to recruitment
- Tobacco consumption in last 12 months
- Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatory diseases, systemic immune diseases, other endocrine diseases or dysfunctions except for PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (eg congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease or without evidence of complete remission for at least 5 years,
- Active participation in an active weight reduction program or hypocaloric diet during the study period. No change in habits will be taught during the study period
- Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04670393
Start Date
December 2 2020
End Date
January 23 2025
Last Update
December 4 2025
Active Locations (1)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036