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

Polycystic Ovary Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670393
• Other study ID #: 2020-FBM+-3
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Fertypharm
• Contact: Eva González
• Phone: +34 932 301 260
• Email: egonzalez[@]fertypharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fertypharm

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of MII oocytes		3 months in follicular puncture visit
Secondary	Glucose	Blood glucose	Baseline and about 2,5 months when the cycle treatment starts
Secondary	Insulin	Blood glucose	Baseline and about 2,5 months when the cycle treatment starts
Secondary	FSH	Follicle Stimulating Hormone in blood	Baseline and about 2,5 months when the cycle treatment starts
Secondary	LH	Luteinizing Homone in blood	Baseline and about 2,5 months when the cycle treatment starts
Secondary	Testosterone	blood testosterone	Baseline and about 2,5 months when the cycle treatment starts
Secondary	Androstendione	blood androstendione	Baseline and about 2,5 months when the cycle treatment starts
Secondary	MDA	Malondialdehyde (MDA) in plasma and follicular liquid	Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Secondary	TAC	Total Antioxidant Capacity (TAC) in plasma and follicular liquid	Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Secondary	8-OH-desoxiguanosin	8-OH-desoxiguanosin in granulose cells	3 months in follicular puncture visit
Secondary	Glutation	Glutation in granulose cells	3 months in follicular puncture visit
Secondary	Sirtuin	Sirtuin in granulose cells	3 months in follicular puncture visit
Secondary	Zonulin	Determination of zonulin in plasma	Baseline and about 2,5 months when the cycle treatment starts
Secondary	SCFA	Determination of Short-Chain Fatty Acids (SCFA) in feces	Baseline and about 2,5 months when the cycle treatment starts
Secondary	Gonadotropin UI		3 months in follicular puncture visit
Secondary	Follicles	Number of follicles >= 11 mm in trigger day	3 months in follicular puncture visit
Secondary	Stimulation days		3 months in follicular puncture visit
Secondary	Oocytes	Number of oocytes obtained, transferred and frozen	3 months in follicular puncture visit
Secondary	Pregnancy rate		Through study completion, an average of 1 year
Secondary	Live birth rate		Through study completion, an average of 1 year