Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-25 @ 2:09 PM
Study NCT ID:
NCT01473459
Status:
UNKNOWN
Last Update Posted:
2012-04-26
First Post:
2011-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069416', 'term': 'Intravital Microscopy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005307', 'term': 'Fertilization in Vitro'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-16', 'lastUpdatePostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fertility results', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['best fertility protocol', '(BMI > 30)', 'women', 'PCOS'], 'conditions': ['Obese', 'Infertility', 'Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.', 'detailedDescription': 'The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30\n* PCOS\n* Failure of COH treatment'}, 'identificationModule': {'nctId': 'NCT01473459', 'briefTitle': 'Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '0078-11-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IVM Treatment', 'interventionNames': ['Procedure: IVM (In Vitro Maturation) Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antagonist Protocol', 'interventionNames': ['Procedure: IVF (In Vitro Fertilization) Antagonist Protocol']}], 'interventions': [{'name': 'IVM (In Vitro Maturation) Treatment', 'type': 'PROCEDURE', 'otherNames': ['IVM'], 'description': 'There will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3.', 'armGroupLabels': ['IVM Treatment']}, {'name': 'IVF (In Vitro Fertilization) Antagonist Protocol', 'type': 'PROCEDURE', 'otherNames': ['IVF - antagonist protocol'], 'description': 'The first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3.', 'armGroupLabels': ['Antagonist Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Tal Shavit, MD', 'role': 'CONTACT', 'email': 'tal.shavit@gmail.com', 'phone': '972-50-6246712'}], 'overallOfficials': [{'name': 'Tal Shavit, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IVF unit Hillel-Yaffe medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}