Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 4:21 PM
Study NCT ID:
NCT00417066
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2006-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-28', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate per embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Duration of ovarian stimulation, total rFSH used, estradiol, LH and progesterone concentration on hCG day.'}, {'measure': 'Number of mature oocytes retrieved.'}, {'measure': 'Number of fertilised oocytes.'}]}, 'conditionsModule': {'keywords': ['poor responders', 'GnRH antagonist', 'GnRH agonist', 'flare up', 'short protocol'], 'conditions': ['Infertility', 'Premature Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '12638782', 'type': 'BACKGROUND', 'citation': 'Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.'}, {'pmid': '18403419', 'type': 'DERIVED', 'citation': 'Lainas TG, Sfontouris IA, Papanikolaou EG, Zorzovilis JZ, Petsas GK, Lainas GT, Kolibianakis EM. Flexible GnRH antagonist versus flare-up GnRH agonist protocol in poor responders treated by IVF: a randomized controlled trial. Hum Reprod. 2008 Jun;23(6):1355-8. doi: 10.1093/humrep/den107. Epub 2008 Apr 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ovulation induction using a flexible GnRH antagonist protocol and flare up GnRH agonist protocol in IVF patients with poor response to ovarian stimulation. Our hypothesis is that the antagonist protocol provides better IVF outcomes compared to the flare up protocol in this group of patients.', 'detailedDescription': 'Poor responders are women who fail to respond effectively to the usual gonadotropin stimulation protocol applied in an IVF cycle. It seems that a diminished ovarian reserve is the principal factor of poor ovarian response. Several strategies have been proposed for the management of poor responders, including flare up GnRH agonist regimens and the GnRH antagonist, which presents a new hope in this group of patients.\n\nComparisons: Poor responder patients (see inclusion criteria) commencing an IVF treatment cyle will receive ovarian stimulation treatment either using a GnRH antagonist (Ganirelix) or flare up agonist (Arvekap) protocol. Primary outcomes compared will be ongoing pregnancy rates in the two treatment groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycle\n* 1 or more failed IVF attempts with poor response\n* 5 or fewer oocytes retrieved\n* FSH\\>12 IU/l on day 3\n\nExclusion Criteria:\n\n* PCOS\n* Normal responders'}, 'identificationModule': {'nctId': 'NCT00417066', 'briefTitle': 'Flexible GnRH Antagonist vs Flare up GnRH Agonist Protocol in Poor Responders', 'organization': {'class': 'OTHER', 'fullName': 'Eugonia'}, 'officialTitle': 'The Flexible GnRH Antagonist Protocol Provides Better Results (IVF Outcomes) Than Flare up GnRH Agonist Protocol in Poor Responders', 'orgStudyIdInfo': {'id': 'poor responders'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ganirelix 0.25mg (Orgalutran, Organon, The Netherlands)', 'type': 'DRUG'}, {'name': 'Arvekap 0.1mg (Triptorelin, Ipsen, France)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Eugonia', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Tryfon Lainas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eugonia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugonia', 'class': 'OTHER'}}}}