Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-29 @ 4:05 AM
Study NCT ID:
NCT00823004
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2009-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antagonist/Letrozole in Poor Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'C014635', 'term': 'lactitol'}, {'id': 'D003276', 'term': 'Contraceptives, Oral'}, {'id': 'D017135', 'term': 'Desogestrel'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D002064', 'term': 'Buserelin'}, {'id': 'C571801', 'term': 'follitropin alfa'}, {'id': 'C527545', 'term': 'hMG-IBSA'}, {'id': 'C061018', 'term': 'ganirelix'}], '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': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'stimulation outcomes', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['controlled ovarian hyperstimulation', 'pregnancy rate', 'Poor responders', 'GnRH antagonist', 'GnRH agonist', 'letrozole', 'in vitro fertilization'], 'conditions': ['Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in assisted reproduction and there is no consensus on the ovarian stimulation choice regime for poor responders.\n\nAim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization (IVF).\n\nMethods: One hundred eighty poor responder patients will be randomized to an ovarian stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH antagonist protocol.', 'detailedDescription': 'All women receive 21 days of an oral contraceptive. A MF protocol will be used for ovarian stimulation in 90 patients. Three days after the last pill, a GnRH-agonist buserelin (Suprefact, Aventis Pharma, Frankfurt, Germany) 50 µg SC twice daily will be initiated and two days after that, recombinant FSH (Gonal-F, Serono, Aubonne, Switzerland) or hMG (Merional, IBSA, Lugano, Switzerland) 300-450 IU/day will be administered. Ninetyty patients will be assigned to an A/L protocol. After oral contraceptive withdrawal bleeding on day 3 of cycle, recombinant FSH or hMG 300-450 IU/day will be initiated and letrozole (Femara, Novartis, East Hanover, NJ) 5 mg/day will be administered for 5 days. When the dominant follicle reached 14 mm in mean diameter, ganirelix acetate (Antagon, Organon, West Orange, NJ) 0.25 mg SC daily will be started.\n\nPatients weill be monitored by serial vaginal ultrasonography and measurement of serum E2 level. When at least two follicles with a mean diameter of 18 mm will be achieved hCG (Pregnyl, Organon, Oss, the Netherlands) 10000 IU will be administered. Cycle cancellation will be considered when fewer than two follicles with normal growth pattern weill be noted.\n\nOocyte retrieval will be performed 34-36 hours after hCG administration. Conventional IVF or intracytoplasmic sperm injection (ICSI) will be performed as appropriate. Embryos with 4-6 equally sized blastomers on day 2 with ≤ 20% fragmentation and no multinucleation will be considered top quality embryos. Embryos with 2-6 equally or unequally blastomers with ≤20% fragmentation and no multinucleation will be considered good quality embryos. Embryos will be transferred on day 2 or 3 under ultrasound guidance, with a C.C.D. embryo transfer catheter ( Laboratoire C.C.D., Paris, France). Luteal support with progesterone in oil (Progesterone, Aburaihan Co., Tehran, Iran) 100 mg daily IM will be started on the day of oocyte retrieval.\n\nSerum β-hCG level will be measured 14 days after embryo transfer and a transvaginal ultrasonography will be performed 3 weeks after positive β-hCG for documentation of gestational sac and fetal heart activity. Clinical pregnancy will be considered as the presence of a gestational sac with fetal heart activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least one previous failed IVF cycle in which three or fewer follicles with a mean diameter of 16 mm were achieved, and/or\n* serum E2 level measured on the day of hCG administration was ≤500 pg/ml\n\nExclusion Criteria:\n\n* day 3 serum FSH level ≥12 mIU/mL\n* there is no age limit'}, 'identificationModule': {'nctId': 'NCT00823004', 'briefTitle': 'Antagonist/Letrozole in Poor Responders', 'organization': {'class': 'OTHER', 'fullName': 'Yazd Research & Clinical Center for Infertility'}, 'officialTitle': 'GnRH Antagonist /Letrozole Versus Microdose GnRH Agonist Flare Protocol in Poor Responders Undergoing in Vitro Fertilization', 'orgStudyIdInfo': {'id': '1969yazdRCCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'A/L: Poor responders who will receive letrozole and GnRH antagonist for ovarian stimulation', 'interventionNames': ['Drug: letrozole', 'Drug: oral contraceptive (Marvelone)', 'Drug: recombinant FSH or hMG', 'Drug: ganirelix acetate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'MF: In this arm poor responders are treated by microdose GnRH agonist flare protocol', 'interventionNames': ['Drug: oral contraceptive (Marvelone)', 'Drug: GnRH agonist (buserelin)', 'Drug: recombinant FSH or hMG']}], 'interventions': [{'name': 'letrozole', 'type': 'DRUG', 'otherNames': ['letrozole (Femara, Novartis, East Hanover, NJ)'], 'description': 'letrozole 5mg/day from day 3 to day 7 of menstrual cycle', 'armGroupLabels': ['1']}, {'name': 'oral contraceptive (Marvelone)', 'type': 'DRUG', 'otherNames': ['Marvelon'], 'description': 'oral contraceptive, first 21 days', 'armGroupLabels': ['1', '2']}, {'name': 'GnRH agonist (buserelin)', 'type': 'DRUG', 'otherNames': ['suprefact'], 'description': '50 µg SC twice daily', 'armGroupLabels': ['2']}, {'name': 'recombinant FSH or hMG', 'type': 'DRUG', 'otherNames': ['Gonal F', 'Merional'], 'description': 'recombinant FSH or hMG 300-450 IU/day', 'armGroupLabels': ['1', '2']}, {'name': 'ganirelix acetate', 'type': 'DRUG', 'otherNames': ['Antagon'], 'description': 'GnRH antagonist (ganirelix acetate) when a leading follicle reaches a mean diameter of 14 mm, 0.25 mg per day (Antagon, Organon, West Orange, NJ)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8916877391', 'city': 'Yazd', 'state': 'Yazd Province', 'country': 'Iran', 'facility': 'Research and clinical center for infertility', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}], 'overallOfficials': [{'name': 'homa oskouian, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research and clinical center for infertility'}, {'name': 'robab davar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research and clinical center for infertility'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yazd Research & Clinical Center for Infertility', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'fellowship', 'investigatorFullName': 'homa oskouian', 'investigatorAffiliation': 'Yazd Research & Clinical Center for Infertility'}}}}