Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT00804960
Status:
WITHDRAWN
Last Update Posted:
2015-06-25
First Post:
2008-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D010062', 'term': 'Ovulation Induction'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of recruitment at this site', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-24', 'studyFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-12-08', 'lastUpdatePostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost of Treatment', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Pregnancy and implantation rates', 'timeFrame': '4 weeks'}, {'measure': 'Incidence of Ovarian Hyper stimulation Syndrome', 'timeFrame': '4 weeks'}, {'measure': 'Multiple Birth Rate', 'timeFrame': '10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cost of Infertility Treatment', 'Ovulation Induction', 'Letrozole', 'In Vitro Fertilization'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.', 'detailedDescription': 'Specific Aim:\n\n1. To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost.\n2. To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols.\n\nNull Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount.\n\nAlternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount.\n\nProtocol:\n\nInfertile women \\<40 years of age with age-appropriate ovarian reserve (as determined by day2/3 E2, FSH, and AMH) will be randomized between two protocols: one with letrozole and one with standard ovulation induction.\n\nIn both groups, serum FSH will be measured each time a sample is obtained for estradiol. Sera will be frozen for further batch assay.\n\nNumber of embryos to be transferred will be decided following the ASRM guidelines. The day of embryo transfer (D-3 vs D-5) will be based on the number and quality of embryos as per established clinical criteria.\n\nPower Considerations\n\nA review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(SD).\n\nFor the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. Thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). For an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm.\n\nAllowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Normal Ovarian Function\n2. Normal uterus\n\nExclusion Criteria:\n\n1. Age 40 and above\n2. Diminished ovarian reserve (based on markers and/or previous poor response)\n3. Previous oophorectomy'}, 'identificationModule': {'nctId': 'NCT00804960', 'acronym': 'Cost-Less', 'briefTitle': 'Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?', 'organization': {'class': 'OTHER', 'fullName': 'Center for Human Reproduction'}, 'officialTitle': 'Controlled Ovarian Stimulation With Letrozole Supplementation', 'orgStudyIdInfo': {'id': 'CHR #5/17/08-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'description': '1\\) Letrozole/ Recombinant FSH', 'interventionNames': ['Drug: Letrozole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard IVF', 'description': 'luteal phase GnRHa suppression/gonadotropin', 'interventionNames': ['Drug: Std IVF Protocol']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Femara'], 'description': '1\\) Letrozole 5 mg starting on cycle day 2, which will be continued until the day of trigger. Recombinant FSH at doses 100-225 units, as determined by BMI, AFC, age, and ovarian reserve markers will be added on cycle day 4. The dose will be adjusted based on the response. An antagonist will be administered once the lead follicle reaches 14-mm in diameter or when estradiol level reaches 250 pg/mL. Oocyte maturation will be triggered by 20 iu of leuprolide acetate.', 'armGroupLabels': ['Letrozole']}, {'name': 'Std IVF Protocol', 'type': 'DRUG', 'otherNames': ['Ovulation induction with Human Menopausal gonoadotropins'], 'description': '2\\) Long protocol with luteal phase GnRHa suppression with gonadotropin dose at 200-450 IU. Oocyte maturation will be triggered by 250 micg of ovidrel.', 'armGroupLabels': ['Standard IVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Human Reproduction', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Barad, MD. MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHR'}, {'name': 'Kutluk Oktay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR/ New York Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Human Reproduction', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kutluk Oktay, MD', 'oldOrganization': 'Center for Human Reproduction'}}}}