Clinical trial NCT04670393: Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
Polycystic Ovary Syndrome
Lead sponsor: Fertypharm
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of MII oocytes
timeFrame: 3 months in follicular puncture visit
Secondary outcomes:
measure: Glucose
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: Insulin
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: FSH
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: LH
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: Testosterone
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: Androstendione
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: MDA
timeFrame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
measure: TAC
timeFrame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
measure: 8-OH-desoxiguanosin
timeFrame: 3 months in follicular puncture visit
measure: Glutation
timeFrame: 3 months in follicular puncture visit
measure: Sirtuin
timeFrame: 3 months in follicular puncture visit
measure: Zonulin
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: SCFA
timeFrame: Baseline and about 2,5 months when the cycle treatment starts
measure: Gonadotropin UI
timeFrame: 3 months in follicular puncture visit
measure: Follicles
timeFrame: 3 months in follicular puncture visit
measure: Stimulation days
timeFrame: 3 months in follicular puncture visit
measure: Oocytes
timeFrame: 3 months in follicular puncture visit
measure: Pregnancy rate
timeFrame: Through study completion, an average of 1 year
measure: Live birth rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: