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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
20
4g Myo-Inositol, 421 mg D-Chiro-Inositol, 400 mcg folic acid, 55 mcg selenium, 15 mcg vitamin D, 1,8 mg melatonin,2x109 Lactobacillus rhamnosus, 2x109 Lactobacillus crispatus and 2x109 Lactobacillus plantarum
400 mcg folic acid
Hospital Clinic
Barcelona, Barcelona, Spain
Number of MII oocytes
Time frame: 3 months in follicular puncture visit
Glucose
Blood glucose
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Insulin
Blood glucose
Time frame: Baseline and about 2,5 months when the cycle treatment starts
FSH
Follicle Stimulating Hormone in blood
Time frame: Baseline and about 2,5 months when the cycle treatment starts
LH
Luteinizing Homone in blood
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Testosterone
blood testosterone
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Androstendione
blood androstendione
Time frame: Baseline and about 2,5 months when the cycle treatment starts
MDA
Malondialdehyde (MDA) in plasma and follicular liquid
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
TAC
Total Antioxidant Capacity (TAC) in plasma and follicular liquid
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
8-OH-desoxiguanosin
8-OH-desoxiguanosin in granulose cells
Time frame: 3 months in follicular puncture visit
Glutation
Glutation in granulose cells
Time frame: 3 months in follicular puncture visit
Sirtuin
Sirtuin in granulose cells
Time frame: 3 months in follicular puncture visit
Zonulin
Determination of zonulin in plasma
Time frame: Baseline and about 2,5 months when the cycle treatment starts
SCFA
Determination of Short-Chain Fatty Acids (SCFA) in feces
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Gonadotropin UI
Time frame: 3 months in follicular puncture visit
Follicles
Number of follicles \>= 11 mm in trigger day
Time frame: 3 months in follicular puncture visit
Stimulation days
Time frame: 3 months in follicular puncture visit
Oocytes
Number of oocytes obtained, transferred and frozen
Time frame: 3 months in follicular puncture visit
Pregnancy rate
Time frame: Through study completion, an average of 1 year
Live birth rate
Time frame: Through study completion, an average of 1 year