Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-10 @ 7:10 AM
Study NCT ID:
NCT00830492
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2009-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'D002064', 'term': 'Buserelin'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '2 weeks'}, {'measure': 'ovarian stimulation safety', 'timeFrame': '3weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clomiphene citrate', 'GnRH agonist', 'GnRH antagonist', 'in vitro fertilization', 'clinical pregnancy', 'pregnancy'], 'conditions': ['Ovarian Stimulation']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome.\n\nDesign: Prospective randomized trial\n\nSetting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation.\n\nIntervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).\n\nMain outcome measure: Clinical pregnancy rate.\n\nKey Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days\n* basal FSH \\<10 IU/L and body mass index (BMI) of 18-30 (kg/m²)\n* Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor\n\nExclusion Criteria:\n\n* patient requiring ICSI'}, 'identificationModule': {'nctId': 'NCT00830492', 'briefTitle': 'Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist', 'organization': {'class': 'OTHER', 'fullName': 'Yazd Research & Clinical Center for Infertility'}, 'officialTitle': 'Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.', 'orgStudyIdInfo': {'id': 'YazdRCCI1388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'In group A (n=100), the patients were stimulated conventional. They desensitized with buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (\\<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg and ovarian stimulation would commence with 150-225 IU recombinant FSH (r\\_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.', 'interventionNames': ['Procedure: Ultrasound', 'Drug: buserelin', 'Drug: rFSH']}, {'type': 'EXPERIMENTAL', 'label': 'clomiphen/gonadotropin/GnRH antagonist', 'description': 'Patients in group B ( n=100 ) were stimulated clomiphene citrate ( ) 100 mg from cycle day three through seven and continuous gonadotropin stimulation with of r\\_FSH 75 IU daily from cycle day 5. Ultrasound in two group was performed on 8 cycle day. In group B 0.25 mg GnRH antagonist (Ganirelix , Organon ,Netherland ) daily was started with dominant follicle ≥14mm and in this day 75 IU human menopoasl gonadotropin (HMG) (Menogon, ferring, pharmacenticals , Germany ) increased to the initial gonadotropin . LH assessment on the day of starting antagonist was performed and if LH was \\>15 IU/L , cycle was cancelled. Human chorionic gonadotropin 10000 IU ((pregnyl, Organon, Oss, the Netherlands ) was given when 1 to 3 follicles reached 18 mm', 'interventionNames': ['Drug: clomiphene citrate', 'Procedure: Ultrasound', 'Drug: GnRH antagonist', 'Drug: gonadotopin (HMG)']}], 'interventions': [{'name': 'clomiphene citrate', 'type': 'DRUG', 'description': '100 mg from cycle day 3 through 7', 'armGroupLabels': ['clomiphen/gonadotropin/GnRH antagonist']}, {'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'cycle day 8', 'armGroupLabels': ['2', 'clomiphen/gonadotropin/GnRH antagonist']}, {'name': 'GnRH antagonist', 'type': 'DRUG', 'description': 'Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).', 'armGroupLabels': ['clomiphen/gonadotropin/GnRH antagonist']}, {'name': 'gonadotopin (HMG)', 'type': 'DRUG', 'description': '75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)', 'armGroupLabels': ['clomiphen/gonadotropin/GnRH antagonist']}, {'name': 'buserelin', 'type': 'DRUG', 'description': 'Buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (\\<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg.', 'armGroupLabels': ['2']}, {'name': 'rFSH', 'type': 'DRUG', 'description': '150-225 IU recombinant FSH (r\\_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yazd', 'state': 'Yazd Province', 'country': 'Iran', 'facility': 'Yazd Research and Clinical Center For Infertility', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yazd Research & Clinical Center for Infertility', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mohammad Ali karimzadeh', 'oldOrganization': 'yazd research and clinical center for IVF'}}}}