Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-30 @ 12:19 PM
Study NCT ID:
NCT04670393
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of MII oocytes', 'timeFrame': '3 months in follicular puncture visit'}], 'secondaryOutcomes': [{'measure': 'Glucose', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Blood glucose'}, {'measure': 'Insulin', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Blood glucose'}, {'measure': 'FSH', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Follicle Stimulating Hormone in blood'}, {'measure': 'LH', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Luteinizing Homone in blood'}, {'measure': 'Testosterone', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'blood testosterone'}, {'measure': 'Androstendione', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'blood androstendione'}, {'measure': 'MDA', 'timeFrame': 'Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)', 'description': 'Malondialdehyde (MDA) in plasma and follicular liquid'}, {'measure': 'TAC', 'timeFrame': 'Baseline (plasma) and 3 months in follicular puncture visit (plasma and follicular puncture)', 'description': 'Total Antioxidant Capacity (TAC) in plasma and follicular liquid'}, {'measure': '8-OH-desoxiguanosin', 'timeFrame': '3 months in follicular puncture visit', 'description': '8-OH-desoxiguanosin in granulose cells'}, {'measure': 'Glutation', 'timeFrame': '3 months in follicular puncture visit', 'description': 'Glutation in granulose cells'}, {'measure': 'Sirtuin', 'timeFrame': '3 months in follicular puncture visit', 'description': 'Sirtuin in granulose cells'}, {'measure': 'Zonulin', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Determination of zonulin in plasma'}, {'measure': 'SCFA', 'timeFrame': 'Baseline and about 2,5 months when the cycle treatment starts', 'description': 'Determination of Short-Chain Fatty Acids (SCFA) in feces'}, {'measure': 'Gonadotropin UI', 'timeFrame': '3 months in follicular puncture visit'}, {'measure': 'Follicles', 'timeFrame': '3 months in follicular puncture visit', 'description': 'Number of follicles \\>= 11 mm in trigger day'}, {'measure': 'Stimulation days', 'timeFrame': '3 months in follicular puncture visit'}, {'measure': 'Oocytes', 'timeFrame': '3 months in follicular puncture visit', 'description': 'Number of oocytes obtained, transferred and frozen'}, {'measure': 'Pregnancy rate', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'Live birth rate', 'timeFrame': 'Through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female', 'Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age:18-38 years old\n* Diagnosis of PCOS according to compliance with the Rotterdam criteria\n* BMI \\>= 25\n\nExclusion Criteria:\n\n* 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\n* Tobacco consumption in last 12 months\n* 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,\n* 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\n* Hypersensitivity to any of the components in the Fertybiotic Mujer Plus® formulation"}, 'identificationModule': {'nctId': 'NCT04670393', 'briefTitle': 'Antioxidant Supplement Associated With Oral Probiotics in Patients With PCOS in IVF', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fertypharm'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2020-FBM+-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FertyBiotic Woman Plus', 'description': 'Participants received FertyBiotic Woman Plus one sachet a day', 'interventionNames': ['Dietary Supplement: FertyBiotic Woman Plus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received 400 mcg of folic acid once a day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'FertyBiotic Woman Plus', 'type': 'DIETARY_SUPPLEMENT', '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', 'armGroupLabels': ['FertyBiotic Woman Plus']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '400 mcg folic acid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fertypharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}