NCT04670393

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fertypharm · Industry
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
OTHER	Placebo	400 mcg folic acid

Timeline

• Start date: 2020-12-02
• Primary completion: 2025-01-23
• Completion: 2025-01-23
• First posted: 2020-12-17
• Last updated: 2025-12-04

Locations

1 site across 1 country: Spain