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OpenTrials
Completed

NCT Number: NCT04670393

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Other

400 mcg folic acid

Primary outcomes

  1. Number of MII oocytes

    Time frame: 3 months in follicular puncture visit

Secondary outcomes

  1. Glucose

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

    Blood glucose

  2. Insulin

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

    Blood glucose

  3. FSH

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

    Follicle Stimulating Hormone in blood

  4. LH

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

    Luteinizing Homone in blood

  5. Testosterone

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

    blood testosterone

  6. Androstendione

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

    blood androstendione

  7. MDA

    Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)

    Malondialdehyde (MDA) in plasma and follicular liquid

  8. TAC

    Time frame: Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)

    Total Antioxidant Capacity (TAC) in plasma and follicular liquid

  9. 8-OH-desoxiguanosin

    Time frame: 3 months in follicular puncture visit

    8-OH-desoxiguanosin in granulose cells

  10. Glutation

    Time frame: 3 months in follicular puncture visit

    Glutation in granulose cells

  11. Sirtuin

    Time frame: 3 months in follicular puncture visit

    Sirtuin in granulose cells

  12. Zonulin

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

    Determination of zonulin in plasma

  13. SCFA

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

    Determination of Short-Chain Fatty Acids (SCFA) in feces

  14. Gonadotropin UI

    Time frame: 3 months in follicular puncture visit

  15. Follicles

    Time frame: 3 months in follicular puncture visit

    Number of follicles >= 11 mm in trigger day

  16. Stimulation days

    Time frame: 3 months in follicular puncture visit

  17. Oocytes

    Time frame: 3 months in follicular puncture visit

    Number of oocytes obtained, transferred and frozen

  18. Pregnancy rate

    Time frame: Through study completion, an average of 1 year

  19. Live birth rate

    Time frame: Through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Fertypharm

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2020
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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