Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF (NCT04670393) | Clinical Trial Compass
CompletedNot Applicable
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Spain20 participantsStarted 2020-12-02
Plain-language 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 fertilization cycle in patients with polycystic ovarian syndrome
Who can participate
Age range18 Years – 38 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age:18-38 years old
* Diagnosis of PCOS according to compliance with the Rotterdam criteria
* BMI \>= 25
Exclusion Criteria:
* 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