Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT00976651
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2009-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium
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': 'D008596', 'term': 'Menotropins'}], 'ancestors': [{'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-24', 'studyFirstSubmitDate': '2009-09-11', 'studyFirstSubmitQcDate': '2009-09-11', 'lastUpdatePostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of oocytes', 'timeFrame': '2 weeks after start of the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infertility', 'ICSI', 'hCG', 'infertility treatment'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '19617207', 'type': 'RESULT', 'citation': 'Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to assess the influence of the administration of low dose hCG on the endometrium. The study is a randomised trial where 2 groups of patients, undergoing a gonadotropin-releasing hormone antagonist protocol for in vitro fertilization, are studied. In addition to the histological findings, by analysing the correlation of the morphological pattern and gene expression profile of human endometrium on the day of oocyte retrieval in patients of both treatment groups, the investigators want to study the implantation potential.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\< 36 years on day of randomisation\n* FSH \\< 12 in the early follicular phase\n* Normal ultrasound scan\n* BMI between 18 and 29 (both inclusive)\n* Randomisation at outpatient clinic\n\nExclusion Criteria:\n\n* Endometriosis ≥ grade 3\n* PCO syndrome\n* Poor responder\n* Endocrine or metabolic abnormalities'}, 'identificationModule': {'nctId': 'NCT00976651', 'briefTitle': 'Low Dose Human Chorionic Gonadotropin: Influence on the Endometrium', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Influence of Ovarian Stimulation With 200 IU of hCG, (Administered in the Late Follicular Phase Among ICSI Patients Undergoing a GnRH-antagonist Protocol), on the Endometrium on the Day of Oocyte Pick-up', 'orgStudyIdInfo': {'id': 'CBLD2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recombinant FSH', 'description': 'Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins. Histology and gene expression is studied on the endometrium.', 'interventionNames': ['Drug: human menopausal gonadotropin']}, {'type': 'EXPERIMENTAL', 'label': 'human chorionic gonadotropin', 'description': 'Patients undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.\n\nHistology and gene expression is studied on the endometrium', 'interventionNames': ['Drug: human menopausal gonadotropin']}], 'interventions': [{'name': 'human menopausal gonadotropin', 'type': 'DRUG', 'description': '200 IU per day in the late follicular phase', 'armGroupLabels': ['Recombinant FSH', 'human chorionic gonadotropin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Laarbeeklaan 101', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paul Devroey', 'oldOrganization': 'Universitair Ziekenhuis Brussel'}}}}