Back to resultsAntioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Primary Purpose
Infertility, Female, Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FertyBiotic Woman Plus
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility, Female
Eligibility Criteria
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
Sites / Locations
- Hospital ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FertyBiotic Woman Plus
Placebo
Arm Description
Participants received FertyBiotic Woman Plus one sachet a day
Participants received 400 mcg of folic acid once a day
Outcomes
Primary Outcome Measures
Number of MII oocytes
Secondary Outcome Measures
Glucose
Blood glucose
Insulin
Blood glucose
FSH
Follicle Stimulating Hormone in blood
LH
Luteinizing Homone in blood
Testosterone
blood testosterone
Androstendione
blood androstendione
MDA
Malondialdehyde (MDA) in plasma and follicular liquid
TAC
Total Antioxidant Capacity (TAC) in plasma and follicular liquid
8-OH-desoxiguanosin
8-OH-desoxiguanosin in granulose cells
Glutation
Glutation in granulose cells
Sirtuin
Sirtuin in granulose cells
Zonulin
Determination of zonulin in plasma
SCFA
Determination of Short-Chain Fatty Acids (SCFA) in feces
Gonadotropin UI
Follicles
Number of follicles >= 11 mm in trigger day
Stimulation days
Oocytes
Number of oocytes obtained, transferred and frozen
Pregnancy rate
Live birth rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04670393
Brief Title
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fertypharm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FertyBiotic Woman Plus
Arm Type
Experimental
Arm Description
Participants received FertyBiotic Woman Plus one sachet a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 400 mcg of folic acid once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
FertyBiotic Woman Plus
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
400 mcg folic acid
Primary Outcome Measure Information:
Title
Number of MII oocytes
Time Frame
3 months in follicular puncture visit
Secondary Outcome Measure Information:
Title
Glucose
Description
Blood glucose
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
Insulin
Description
Blood glucose
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
FSH
Description
Follicle Stimulating Hormone in blood
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
LH
Description
Luteinizing Homone in blood
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
Testosterone
Description
blood testosterone
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
Androstendione
Description
blood androstendione
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
MDA
Description
Malondialdehyde (MDA) in plasma and follicular liquid
Time Frame
Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Title
TAC
Description
Total Antioxidant Capacity (TAC) in plasma and follicular liquid
Time Frame
Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)
Title
8-OH-desoxiguanosin
Description
8-OH-desoxiguanosin in granulose cells
Time Frame
3 months in follicular puncture visit
Title
Glutation
Description
Glutation in granulose cells
Time Frame
3 months in follicular puncture visit
Title
Sirtuin
Description
Sirtuin in granulose cells
Time Frame
3 months in follicular puncture visit
Title
Zonulin
Description
Determination of zonulin in plasma
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
SCFA
Description
Determination of Short-Chain Fatty Acids (SCFA) in feces
Time Frame
Baseline and about 2,5 months when the cycle treatment starts
Title
Gonadotropin UI
Time Frame
3 months in follicular puncture visit
Title
Follicles
Description
Number of follicles >= 11 mm in trigger day
Time Frame
3 months in follicular puncture visit
Title
Stimulation days
Time Frame
3 months in follicular puncture visit
Title
Oocytes
Description
Number of oocytes obtained, transferred and frozen
Time Frame
3 months in follicular puncture visit
Title
Pregnancy rate
Time Frame
Through study completion, an average of 1 year
Title
Live birth rate
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva González
Phone
+34 932 301 260
Email
egonzalez@fertypharm.com
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gemma Casals, MD
Phone
932275400
Email
GCASALS@clinic.cat
12. IPD Sharing Statement
Plan to Share IPD
No
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Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
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