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

• Sponsor: Fertypharm (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04670393
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female; Polycystic Ovary Syndrome	Dietary Supplement: FertyBiotic Woman Plus; Other: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Dec 2, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FertyBiotic Woman Plus Participants received FertyBiotic Woman Plus one sachet a day	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
Placebo Comparator: Placebo Participants received 400 mcg of folic acid once a day	Other: Placebo; 400 mcg folic acid

Outcome Measures

Primary Outcome Measures

1. Number of MII oocytes [3 months in follicular puncture visit]

Secondary Outcome Measures

1. Glucose [Baseline and about 2,5 months when the cycle treatment starts]

   Blood glucose

2. Insulin [Baseline and about 2,5 months when the cycle treatment starts]

   Blood glucose

3. FSH [Baseline and about 2,5 months when the cycle treatment starts]

   Follicle Stimulating Hormone in blood

4. LH [Baseline and about 2,5 months when the cycle treatment starts]

   Luteinizing Homone in blood

5. Testosterone [Baseline and about 2,5 months when the cycle treatment starts]

   blood testosterone

6. Androstendione [Baseline and about 2,5 months when the cycle treatment starts]

   blood androstendione

7. MDA [Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)]

   Malondialdehyde (MDA) in plasma and follicular liquid

8. TAC [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 [3 months in follicular puncture visit]

   8-OH-desoxiguanosin in granulose cells

10. Glutation [3 months in follicular puncture visit]

    Glutation in granulose cells

11. Sirtuin [3 months in follicular puncture visit]

    Sirtuin in granulose cells

12. Zonulin [Baseline and about 2,5 months when the cycle treatment starts]

    Determination of zonulin in plasma

13. SCFA [Baseline and about 2,5 months when the cycle treatment starts]

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

14. Gonadotropin UI [3 months in follicular puncture visit]

15. Follicles [3 months in follicular puncture visit]

    Number of follicles >= 11 mm in trigger day

16. Stimulation days [3 months in follicular puncture visit]

17. Oocytes [3 months in follicular puncture visit]

    Number of oocytes obtained, transferred and frozen

18. Pregnancy rate [Through study completion, an average of 1 year]

19. Live birth rate [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona		Spain	08036

Sponsors and Collaborators

• Fertypharm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fertypharm
• ClinicalTrials.gov Identifier: NCT04670393
• Other Study ID Numbers: 2020-FBM+-3
• First Posted: Dec 17, 2020
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female; Syndrome

Study Results

No Results Posted as of Mar 15, 2022