Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT00615251
Status:
COMPLETED
Last Update Posted:
2013-09-13
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'dispFirstSubmitDate': '2011-06-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-30', 'studyFirstSubmitDate': '2008-02-04', 'dispFirstSubmitQcDate': '2011-06-08', 'studyFirstSubmitQcDate': '2008-02-04', 'dispFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy', 'timeFrame': '8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy', 'timeFrame': 'Duration of study'}, {'measure': 'Adverse events', 'timeFrame': 'Duration of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In vitro fertilization'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '30396554', 'type': 'DERIVED', 'citation': 'Ginsburg ES, Jellerette-Nolan T, Daftary G, Du Y, Silverberg KM. Patient experience in a randomized trial of a weekly progesterone vaginal ring versus a daily progesterone gel for luteal support after in vitro fertilization. Fertil Steril. 2018 Nov;110(6):1101-1108.e3. doi: 10.1016/j.fertnstert.2018.07.014.'}, {'pmid': '23465817', 'type': 'DERIVED', 'citation': 'Stadtmauer L, Silverberg KM, Ginsburg ES, Weiss H, Howard B. Progesterone vaginal ring versus vaginal gel for luteal support with in vitro fertilization: a randomized comparative study. Fertil Steril. 2013 May;99(6):1543-9. doi: 10.1016/j.fertnstert.2012.12.052. Epub 2013 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-menopausal, aged 18-42 old at time of consent\n* At least one cycle without fertility medication prior to screening\n* Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility\n* Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)\n* Others as indicated by FDA-approved protocol\n\nExclusion Criteria:\n\n* Any contraindication to progesterone therapy\n* BMI \\> 38 kg/m2\n* Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)\n* History of more than 1 failed fresh IVF cycles\n* More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)\n* Others as indicated by FDA-approved protocol'}, 'identificationModule': {'nctId': 'NCT00615251', 'briefTitle': 'A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization', 'orgStudyIdInfo': {'id': 'DR-PGN-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DR-2011']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Crinone 8%']}], 'interventions': [{'name': 'DR-2011', 'type': 'DRUG', 'description': 'Progesterone vaginal ring for approximately 10 weeks', 'armGroupLabels': ['1']}, {'name': 'Crinone 8%', 'type': 'DRUG', 'description': 'progesterone vaginal gel for approximately 10 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '90064', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'zip': '91361', 'city': 'Westlake', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.69771, 'lon': -122.48053}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational 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