Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-02 @ 2:20 PM
Study NCT ID:
NCT00415792
Status:
UNKNOWN
Last Update Posted:
2007-01-05
First Post:
2006-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs
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': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-07'}, 'lastUpdateSubmitDate': '2007-01-04', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-23', 'lastUpdatePostDateStruct': {'date': '2007-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy per embryo transfer'}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy per embryo transfer'}, {'measure': 'Clinical pregnancy per embryo transfer'}, {'measure': 'Embryological data'}]}, 'conditionsModule': {'keywords': ['Ovulation induction', 'hCG', 'GnRH agonist', 'hyper-responders'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '16254001', 'type': 'BACKGROUND', 'citation': 'Griesinger G, Diedrich K, Devroey P, Kolibianakis EM. GnRH agonist for triggering final oocyte maturation in the GnRH antagonist ovarian hyperstimulation protocol: a systematic review and meta-analysis. Hum Reprod Update. 2006 Mar-Apr;12(2):159-68. doi: 10.1093/humupd/dmi045. Epub 2005 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'hCG and GnRH agonist can be used to induce final oocyte maturation and ovulation in IVF cycles. These two approaches will be compared in this study in terms of pregnancy rates and embryological data using patients with hyper-response to IVF drugs.', 'detailedDescription': 'hCG is commonly used for the substitution of the endogenous LH surge to induce oocyte maturation and ovulation induction in ovarian hyperstimulation protocols for in vitro fertilization (IVF). However, hCG is related to the occurrence of the ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening complication and hyper-responding patients are particularly in high risk. An alternative to exogenous hCG is the administration of a GnRH agonist inducing an endogenous rise in both LH and FSH levels due to the initial flare effect.\n\nComparisons: Pregnancy rates and embryological data will be compared from hyper-responding patients receiving either GnRH agonist (Arvekap) or hCG (Pregnyl) for ovulatrion induction following a GnRH antagonist treatment cycle.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyper-responder patients (\\>20 oocytes retrieved)\n\nExclusion Criteria:\n\n* Normal responders\n* Poor responders\n* PCOS'}, 'identificationModule': {'nctId': 'NCT00415792', 'briefTitle': 'Comparison Between hCG and GnRH Agonist for Ovulation Induction in Patients With High Response to IVF Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Eugonia'}, 'officialTitle': 'Administration of Human Chorionic Gonadotropin (hCG) Versus Gonadotropin Releasing Hormone (GnRH) Agonist for Ovulation Induction in Hyper-Responder Patients', 'orgStudyIdInfo': {'id': 'arvekap vs pregnyl'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Arvekap, Pregnyl', '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eugonia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugonia', 'class': 'OTHER'}}}}