Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00635258
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2008-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Administration of GnRH Antagonist to Oocyte Donation Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-06', 'studyFirstSubmitDate': '2008-02-26', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pregnancy and implantation rates', 'timeFrame': '"at 7 weeks"'}], 'secondaryOutcomes': [{'measure': 'age of the recipients, body mass index, days undergoing oestrogen therapy', 'timeFrame': '"at 1 mounth"'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'oocyte donation', 'pregnancy', 'implantation'], 'conditions': ['Pregnancy', 'Embryo Implantation']}, 'referencesModule': {'references': [{'pmid': '10770169', 'type': 'BACKGROUND', 'citation': 'Casan EM, Raga F, Bonilla-Musoles F, Polan ML. Human oviductal gonadotropin-releasing hormone: possible implications in fertilization, early embryonic development, and implantation. J Clin Endocrinol Metab. 2000 Apr;85(4):1377-81. doi: 10.1210/jcem.85.4.6503.'}, {'pmid': '10433230', 'type': 'BACKGROUND', 'citation': 'Raga F, Casan EM, Kruessel J, Wen Y, Bonilla-Musoles F, Polan ML. The role of gonadotropin-releasing hormone in murine preimplantation embryonic development. Endocrinology. 1999 Aug;140(8):3705-12. doi: 10.1210/endo.140.8.6899.'}, {'pmid': '10333357', 'type': 'BACKGROUND', 'citation': 'Casan EM, Raga F, Polan ML. GnRH mRNA and protein expression in human preimplantation embryos. Mol Hum Reprod. 1999 Mar;5(3):234-9. doi: 10.1093/molehr/5.3.234.'}, {'pmid': '10022430', 'type': 'BACKGROUND', 'citation': 'Raga F, Casan EM, Wen Y, Huang HY, Bonilla-Musoles F, Polan ML. Independent regulation of matrix metalloproteinase-9, tissue inhibitor of metalloproteinase-1 (TIMP-1), and TIMP-3 in human endometrial stromal cells by gonadotropin-releasing hormone: implications in early human implantation. J Clin Endocrinol Metab. 1999 Feb;84(2):636-42. doi: 10.1210/jcem.84.2.5464.'}, {'pmid': '9716567', 'type': 'BACKGROUND', 'citation': 'Raga F, Casan EM, Kruessel JS, Wen Y, Huang HY, Nezhat C, Polan ML. Quantitative gonadotropin-releasing hormone gene expression and immunohistochemical localization in human endometrium throughout the menstrual cycle. Biol Reprod. 1998 Sep;59(3):661-9. doi: 10.1095/biolreprod59.3.661.'}]}, 'descriptionModule': {'briefSummary': 'This prospective and randomized study was performed to evaluate whether the replacement of GnRH agonist by a GnRH antagonist in oocyte donation recipients during endometrial preparation has any impact on pregnancy and implantation rates.', 'detailedDescription': 'This was a prospective and randomized study undertaken between January 2004 and December 2007. One hundred patients with an indication for oocyte donation with functioning ovaries and IVF with or without intracytoplasmatic sperm injection (ICSI) were recruited for the study. After assignment to IVF or IVF/ICSI randomization was performed to 1 of the 2 treatment groups (GnRH agonist or GnRH antagonist during endometrial preparation in oocyte donation recipients) using a computed-generated randomization schedule assigned via numbered sealed envelopes.\n\nIn our program, we used excess oocytes from IVF that were voluntarily donated by patients after informed consent.\n\nThe indications for oocyte donation were reduced ovarian reserve (59%), recurrent IVF failures (21%), premature ovarian failure (16%), and genetic anomaly (4%).\n\nThis study was performed according to the declaration of Helsinki and the European Community note on Good Clinical Practice for trials on medical products in the European Community (CPMP Working Party on Efficacy of Medical Products, 1990). Furthermore, the local ethics committee approved the study protocol, and written informed consent was obtained from all patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '34 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an indication for oocyte donation with functioning ovaries.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-34 years\n* Body mass index between 19-30 kg/m2;\n* History of regular menstrual cycles, ranging from 25-35 days\n* No relevant systemic disease (all patients were screened for hepatitis B and C, human immunodeficiency viruses I and II, syphylis, and vaginal infection), genetic disease, severe endometriosis or pelvic inflamatory disease\n* No more than two previous IVF cycles; and\n* No previous IVF cycles with poor response (less than three oocytes in a previous IVF cycle) or severe ovarian hyperstimulation syndrome.\n\nExclusion Criteria:\n\n* Patients without inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT00635258', 'acronym': 'GnRH-Ovodon', 'briefTitle': 'Administration of GnRH Antagonist to Oocyte Donation Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Centro Ginecologia y Obstetricia.'}, 'officialTitle': 'Administration of GnRH Antagonist to Oocyte Donation Recipients During Endometrial Preparation.', 'orgStudyIdInfo': {'id': 'GnRH-ant.Ovodon'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GnRH-ant', 'description': "Patients were treated with a GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.", 'interventionNames': ['Drug: GnRH antagonist (Orgalutran®)']}, {'label': 'GnRH-a', 'description': "GnRH long protocol using 0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state. Furthermore, the triptorelin administration was maintained until the day of donor's hCG administration.", 'interventionNames': ['Drug: triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)']}], 'interventions': [{'name': 'triptorelin (Decapeptyl®, Ipsen Pharma, Barcelona, Spain)', 'type': 'DRUG', 'otherNames': ['GnRH agonist'], 'description': '0.1 mg/day triptorelin s.c (Decapeptyl®, Ipsen Pharma, Barcelona, Spain) was started on day 21-24 of the preceding cycle for at least 14 days to produce an agonadal state.', 'armGroupLabels': ['GnRH-a']}, {'name': 'GnRH antagonist (Orgalutran®)', 'type': 'DRUG', 'otherNames': ['GnRH antagonist'], 'description': "GnRH antagonist (Orgalutran®; 0,25 mg/d, sc.) commencing on day 1 of the menstrual cycle and maintained until the day of donor's hCG administration.", 'armGroupLabels': ['GnRH-ant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46004', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'CEGIOB', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Raga Francisco, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Ginecologia y Obstetricia.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Ginecologia y Obstetricia.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Valencia', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Fernando Bonilla-Musoles', 'oldOrganization': 'CEGIOB'}}}}