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

NCT04670393 | Completed

• 1 other identifier: 2020-FBM+-3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of MII oocytes

  3 months in follicular puncture visit

Secondary Outcomes (19)

• Glucose

  Baseline and about 2,5 months when the cycle treatment starts

• Insulin

  Baseline and about 2,5 months when the cycle treatment starts

• FSH

  Baseline and about 2,5 months when the cycle treatment starts

• LH

  Baseline and about 2,5 months when the cycle treatment starts

• Testosterone

  Baseline and about 2,5 months when the cycle treatment starts

Study Arms (2)

FertyBiotic Woman Plus

EXPERIMENTAL

Participants received FertyBiotic Woman Plus one sachet a day

Dietary Supplement: FertyBiotic Woman Plus

Placebo

PLACEBO COMPARATOR

Participants received 400 mcg of folic acid once a day

Other: Placebo

Interventions

FertyBiotic Woman Plus 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

FertyBiotic Woman Plus

Placebo OTHER

400 mcg folic acid

Placebo

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age:18-38 years old
• Diagnosis of PCOS according to compliance with the Rotterdam criteria
• BMI \>= 25

You may not qualify if:

• 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

Sponsors & Collaborators

• Fertypharm: lead

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Infertility, Female; Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: December 2, 2020
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)