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

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

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Infertility, Female
• Intervention / Treatment: Dietary supplement: FertyBiotic Woman Plus; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FertyBiotic Woman Plus; Participants received FertyBiotic Woman Plus one sachet a day	Dietary supplement: FertyBiotic Woman Plus; 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
Placebo Comparator: Placebo; Participants received 400 mcg of folic acid once a day	Other: Placebo; 400 mcg folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of MII oocytes	3 months in follicular puncture visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fertypharm

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2020
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Infertility; Polycystic Ovary Syndrome; Infertility, Female
• Other Study ID Numbers: 2020-FBM+-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No