Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:42 AM
Study NCT ID:
NCT01298960
Status:
TERMINATED
Last Update Posted:
2020-02-12
First Post:
2011-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'id': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2011-02-17', 'studyFirstSubmitQcDate': '2011-02-17', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of metaphase II oocytes retrieved', 'timeFrame': '3 months after having finished recruitment'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '9 months after ovum pick-up'}, {'measure': 'Adverse events due to rGH', 'timeFrame': '3 months after having finished recruitment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Poor Ovarian response in IVF', 'Metaphase II oocytes', 'Pregnancy Rate', 'Growth Hormone'], 'conditions': ['Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer']}, 'referencesModule': {'references': [{'pmid': '12917883', 'type': 'BACKGROUND', 'citation': 'Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.'}, {'pmid': '19561136', 'type': 'BACKGROUND', 'citation': 'Kolibianakis EM, Venetis CA, Diedrich K, Tarlatzis BC, Griesinger G. Addition of growth hormone to gonadotrophins in ovarian stimulation of poor responders treated by in-vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2009 Nov-Dec;15(6):613-22. doi: 10.1093/humupd/dmp026. Epub 2009 Jun 26.'}], 'seeAlsoLinks': [{'url': 'http://www.dexeus.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.\n* Infertility requiring IVF with or without ICSI.\n* Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - \\< 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count \\< 5.\n* Partner sperm.\n* Presence of both ovaries and normal uterine cavity.\n* PAP smear within normality in previous 3 years.\n* Negative pregnancy test (serum or urine) before rFSH administration.\n* Willingness of adhesion to protocol during the whole study period.\n* Signed informed consent given.\n\nExclusion Criteria:\n\n* HIV, HCV, HBV positive serologies in women or partner.\n* Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).\n* BMI \\> 32 kg/m2 or antecedent of diabetes mellitus.\n* Gonadotrophin treatment within the previous 30 days.\n* Availability of frozen embryos of previous IVF cycles .\n* Abnormal uterine bleeding.\n* Previous treatment with LH or LH effect drugs.\n* Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.\n* Contraindication for pregnancy.\n* Allergies to gonadotrophins or somatotropin.\n* History of drug or alcohol abuse in the previous 5 years.\n* Previous enrollment in this study or simultaneous participation in another study with drugs.'}, 'identificationModule': {'nctId': 'NCT01298960', 'acronym': 'FUNDEX001', 'briefTitle': 'Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Dexeus'}, 'officialTitle': 'Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response', 'orgStudyIdInfo': {'id': 'FUNDEX001'}, 'secondaryIdInfos': [{'id': '2010-022151-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rGH Group', 'interventionNames': ['Drug: Somatropin']}, {'type': 'NO_INTERVENTION', 'label': 'Non rGH group'}], 'interventions': [{'name': 'Somatropin', 'type': 'DRUG', 'description': '0.1 IU/Kg/day from day one of stimulation until rHCG triggering', 'armGroupLabels': ['rGH Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08037', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Pedro N Barri, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus'}, {'name': 'Buenaventura Coroleu, PhD. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus'}, {'name': 'Marta Devesa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus'}, {'name': 'Francisca Martinez, PhD. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Dexeus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'BSC', 'investigatorFullName': 'Ignacio Rodriguez MSc', 'investigatorAffiliation': 'Fundacion Dexeus'}}}}