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

Not Applicable

• Conditions: Infertility, Female; Polycystic Ovary Syndrome
• Interventions: Other: Placebo; Dietary Supplement: FertyBiotic Woman Plus

• Registration Number: NCT04670393
• Lead Sponsor: Fertypharm

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 fertilization cycle in patients with polycystic ovarian syndrome

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 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 Timeline

• Study Start: 2020-12-02
• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-17
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received 400 mcg of folic acid once a day
FertyBiotic Woman Plus	FertyBiotic Woman Plus	Participants received FertyBiotic Woman Plus one sachet a day

Primary Outcome Measures

Name	Time	Method
Number of MII oocytes	3 months in follicular puncture visit

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Through study completion, an average of 1 year
Insulin	Baseline and about 2,5 months when the cycle treatment starts	Blood glucose
LH	Baseline and about 2,5 months when the cycle treatment starts	Luteinizing Homone in blood
SCFA	Baseline and about 2,5 months when the cycle treatment starts	Determination of Short-Chain Fatty Acids (SCFA) in feces
Oocytes	3 months in follicular puncture visit	Number of oocytes obtained, transferred and frozen
FSH	Baseline and about 2,5 months when the cycle treatment starts	Follicle Stimulating Hormone in blood
Sirtuin	3 months in follicular puncture visit	Sirtuin in granulose cells
Pregnancy rate	Through study completion, an average of 1 year
Glucose	Baseline and about 2,5 months when the cycle treatment starts	Blood glucose
Androstendione	Baseline and about 2,5 months when the cycle treatment starts	blood androstendione
Testosterone	Baseline and about 2,5 months when the cycle treatment starts	blood testosterone
Glutation	3 months in follicular puncture visit	Glutation in granulose cells
Zonulin	Baseline and about 2,5 months when the cycle treatment starts	Determination of zonulin in plasma
Follicles	3 months in follicular puncture visit	Number of follicles \>= 11 mm in trigger day
Stimulation days	3 months in follicular puncture visit
MDA	Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)	Malondialdehyde (MDA) in plasma and follicular liquid
TAC	Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)	Total Antioxidant Capacity (TAC) in plasma and follicular liquid
8-OH-desoxiguanosin	3 months in follicular puncture visit	8-OH-desoxiguanosin in granulose cells
Gonadotropin UI	3 months in follicular puncture visit

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain