Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF

Fertypharm

Status: Unknown

Conditions: Polycystic Ovary Syndrome; Infertility, Female

Treatments: Other: Placebo; Dietary Supplement: FertyBiotic Woman Plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04670393

2020-FBM+-3

Details and patient eligibility

About

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

Full 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 the antioxidant supplementation associated with probiotics (Myo-Inositol, D-Chiro-Inositol, folic acid, selenium, vitamin D, Melatonin, Lactobacillus rhamnosus, Lactobacillus cripatus and Lactobacillus plantarum) or placebo (folic acid) once daily.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

FertyBiotic Woman Plus

Experimental group

Description:

Participants received FertyBiotic Woman Plus one sachet a day

Treatment:

Dietary Supplement: FertyBiotic Woman Plus

Placebo

Placebo Comparator group

Description:

Participants received 400 mcg of folic acid once a day

Treatment:

Other: Placebo