Hospital Clinic
Barcelona, 08036, Spain
NCT Number: NCT04670393
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
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Notify Me18 year–38 year
Female
Interventional
Not applicable
Barcelona, 08036, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 months in follicular puncture visit
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Blood glucose
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Blood glucose
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Follicle Stimulating Hormone in blood
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Luteinizing Homone in blood
Time frame: Baseline and about 2,5 months when the cycle treatment starts
blood testosterone
Time frame: Baseline and about 2,5 months when the cycle treatment starts
blood androstendione
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Malondialdehyde (MDA) in plasma and follicular liquid
Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Total Antioxidant Capacity (TAC) in plasma and follicular liquid
Time frame: 3 months in follicular puncture visit
8-OH-desoxiguanosin in granulose cells
Time frame: 3 months in follicular puncture visit
Glutation in granulose cells
Time frame: 3 months in follicular puncture visit
Sirtuin in granulose cells
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Determination of zonulin in plasma
Time frame: Baseline and about 2,5 months when the cycle treatment starts
Determination of Short-Chain Fatty Acids (SCFA) in feces
Time frame: 3 months in follicular puncture visit
Time frame: 3 months in follicular puncture visit
Number of follicles >= 11 mm in trigger day
Time frame: 3 months in follicular puncture visit
Time frame: 3 months in follicular puncture visit
Number of oocytes obtained, transferred and frozen
Time frame: Through study completion, an average of 1 year
Time frame: Through study completion, an average of 1 year
Fertypharm
Industry
Impact of the Administration of an Antioxidant Food Supplement Associated With Oral Probiotics on the Ovarian Oxidative Stress Profile and the Intestinal Microbiota Function in the in Vitro Fertilization Cycle of Patients With Polycystic Ovarian Syndrome
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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