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

NCT ID: NCT04670393

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2025-01-23

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.

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

FertyBiotic Woman Plus

Participants received FertyBiotic Woman Plus one sachet a day

Group Type: EXPERIMENTAL

FertyBiotic Woman Plus

Intervention Type: DIETARY_SUPPLEMENT

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

Participants received 400 mcg of folic acid once a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

400 mcg folic acid

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

400 mcg folic acid

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fertypharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

2020-FBM+-3

Identifier Type: -

Identifier Source: org_study_id