Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-04-21 @ 9:20 PM
Study NCT ID:
NCT02848950
Status:
UNKNOWN
Last Update Posted:
2016-07-29
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-07-26', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': 'until the blood test for pregnancy, about 4-6 weeks'}], 'secondaryOutcomes': [{'measure': 'The changes in Doppler blood flow indices in both uterine arteries', 'timeFrame': 'until the blood test for pregnancy, about 4-6 weeks'}, {'measure': 'endometrial thickness change measured by millimeters', 'timeFrame': 'until the blood test for pregnancy, about 4-6 weeks'}, {'measure': 'Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows', 'timeFrame': 'until the blood test for pregnancy, about 4-6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metformin', 'fecundability', 'uterine doppler'], 'conditions': ['Infertility Female']}, 'descriptionModule': {'briefSummary': "The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.\n\nInsulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.", 'detailedDescription': "Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.\n\nIt is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.\n\nThis study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: from 18-40 years old.\n* BMI \\> 30\n* Infertile women undergoing frozen-thawed embryo transfer in an ART setting\n* Women with at least one Top graded embryo\n* Normal uterine Doppler indices at time of recruitment.\n\nExclusion Criteria:\n\n* Diabetes mellitus - uncontrolled.\n* Hyperprolactinemia- uncontrolled.\n* Hypothyroidism- uncontrolled.\n* women who are already treated with Metformin\n* women with endometrial factor as the cause for infertility'}, 'identificationModule': {'nctId': 'NCT02848950', 'briefTitle': 'The Effect of Metformin on Fecundability in an ART(Assisted Reproductive Technology) Setting - the Correlation to Uterine Flows', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': 'The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'M.UTERUS.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'treatment', 'description': 'drug: metformin', 'interventionNames': ['Drug: Metformin']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'without metformin'}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['glucophage'], 'description': 'Supplementation of the study group with Metformin till the day of pregnancy confirmation', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'nora gorhad shabso, doctor', 'role': 'CONTACT', 'email': 'ngorhad@poria.health.gov.il'}], 'overallOfficials': [{'name': 'JOHNNY YOUNIS, PEOFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Head of Fertility unit, Poriya' Bar Ilan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DOCTOR', 'investigatorFullName': 'nora gorhad', 'investigatorAffiliation': 'The Baruch Padeh Medical Center, Poriya'}}}}