Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT00374634
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2006-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-30', 'studyFirstSubmitDate': '2006-09-08', 'studyFirstSubmitQcDate': '2006-09-08', 'lastUpdatePostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of mature follicles in the study and control group.'}], 'secondaryOutcomes': [{'measure': 'Number of cycles where the rFSH dose is changed.'}, {'measure': 'Number of cycles cancelled or converted to in vitro fertilisation.'}, {'measure': 'Pregnancy rate.', 'timeFrame': 'October 2008'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '19602518', 'type': 'BACKGROUND', 'citation': 'la Cour Freiesleben N, Lossl K, Bogstad J, Bredkjaer HE, Toft B, Rosendahl M, Loft A, Bangsboll S, Pinborg A, Nyboe Andersen A. Individual versus standard dose of rFSH in a mild stimulation protocol for intrauterine insemination: a randomized study. Hum Reprod. 2009 Oct;24(10):2523-30. doi: 10.1093/humrep/dep239. Epub 2009 Jul 14.'}, {'pmid': '20303323', 'type': 'DERIVED', 'citation': 'Freiesleben Nl, Rosendahl M, Johannsen TH, Lossl K, Loft A, Bangsboll S, Friis-Hansen L, Pinborg A, Andersen AN. Prospective investigation of serum anti-Mullerian hormone concentration in ovulatory intrauterine insemination patients: a preliminary study. Reprod Biomed Online. 2010 May;20(5):582-7. doi: 10.1016/j.rbmo.2010.02.007. Epub 2010 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if recombinant follicle stimulating hormone (rFSH) given in individual doses, according to a nomogram we have constructed based on our results from a previous study, results in more patients maturing 2-3 follicles compared to standard dose.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 25-39 years\n* First stimulation with rFSH only\n* Indication for intrauterine insemination with standard rFSH starting dose\n* Regular menstrual bleeding with a cycle between 21-35 days\n* Two ovaries\n* Bilateral tuba patency\n* Semen analysis must be sufficient for insemination according to the diagnostic analysis.\n\nExclusion Criteria:\n\n* More than three former stimulated intrauterine insemination cycles'}, 'identificationModule': {'nctId': 'NCT00374634', 'briefTitle': 'Individual Versus Standard Follicle Stimulating Hormone Dose for Controlled Ovarian Stimulation and Insemination', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Individual Versus Standard rFSH Dose for Controlled Ovarian Stimulation and Intrauterine Insemination. A Prospective Randomised Multi Centre Study', 'orgStudyIdInfo': {'id': 'indvFSH2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '"Individual" or "standard" rFSH dose', 'description': 'Patients were randomized to recieve "individual" (50, 75 or 100 IU/day) or "standard" (75 IU/day) rFSh dose. The individual dose was prescribed according to a dosage nomogram based on the patient\'s body weight (kg) and the total antral follicle count (Freiesleben NC et al., RBMOnline 2009;17:632-64).', 'interventionNames': ['Drug: rFSH drug dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': '"Standard" rFSH dose', 'description': '"Standard" dose of rFSH', 'interventionNames': ['Drug: "Standard" rFSH dose']}], 'interventions': [{'name': 'rFSH drug dose', 'type': 'DRUG', 'description': '"Individual" rFSH dose (50, 75 or 100 IU rFSH/day)', 'armGroupLabels': ['"Individual" or "standard" rFSH dose']}, {'name': '"Standard" rFSH dose', 'type': 'DRUG', 'description': '"Standard" rFSH dose was 75 IU/day', 'armGroupLabels': ['"Standard" rFSH dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen East', 'country': 'Denmark', 'facility': 'The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet'}], 'overallOfficials': [{'name': 'Anders N Andersen, Professor,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Fertility Clinic, dep.4071, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen East, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nina la Cour Freiesleben', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Nina la Cour Freiesleben', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}