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

Last updated: November 26, 2025
Sponsor: Fertypharm
Overall Status: Completed

Phase

N/A

Condition

Reproductive Health

Infertility

Polycystic Ovarian Syndrome

Treatment

FertyBiotic Woman Plus

Placebo

Clinical Study ID

NCT04670393
2020-FBM+-3
  • Ages 18-38
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age:18-38 years old

  • Diagnosis of PCOS according to compliance with the Rotterdam criteria

  • BMI >= 25

Exclusion

Exclusion Criteria:

  • Hormonal contraceptive, insulin sensitizers such as metformin, inositols,antioxidants, vitamin supplements except folic acid, GnRH analogs, steroidal drugsor others with anti-inflammatory properties, antibiotics, probiotics, laxatives usein the 3 months prior to recruitment

  • Tobacco consumption in last 12 months

  • Endometriosis, hydrosalpinx not surgically treated, acute or chronic inflammatorydiseases, systemic immune diseases, other endocrine diseases or dysfunctions exceptfor PCOS and subclinical hypothyroidism treated with low doses of levothyroxine (egcongenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors,Diabetes Millitus, hyperprolactinemia, hyperglycemia), active neoplastic disease orwithout evidence of complete remission for at least 5 years,

  • Active participation in an active weight reduction program or hypocaloric dietduring 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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: FertyBiotic Woman Plus
Phase:
Study Start date:
December 02, 2020
Estimated Completion Date:
January 23, 2025

Study 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.

Connect with a study center

  • Hospital Clinic

    Barcelona 3128760, Barcelona 08036
    Spain

    Site Not Available

  • Hospital Clinic

    Barcelona, 08036
    Spain

    Site Not Available

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