Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02338206
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Protocol and Growth Hormone in Poor Responders
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': 'D013006', 'term': 'Growth Hormone'}, {'id': 'D019382', 'term': 'Human Growth Hormone'}], 'ancestors': [{'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': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth rate', 'timeFrame': '12 months', 'description': 'Fresh, Frozen, Cumulative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infertility'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '29957401', 'type': 'DERIVED', 'citation': 'Dakhly DMR, Bassiouny YA, Bayoumi YA, Hassan MA, Gouda HM, Hassan AA. The addition of growth hormone adjuvant therapy to the long down regulation protocol in poor responders undergoing in vitro fertilization: Randomized control trial. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:161-165. doi: 10.1016/j.ejogrb.2018.06.035. Epub 2018 Jun 22.'}]}, 'descriptionModule': {'briefSummary': 'The long down regulation protocol is widely used in the in vitro fertilization cycles, now it will be assessed regarding its efficacy, in poor responder females undergoing in vitro fertilization cycles, alone and after the addition of growth hormone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Poor responder females are those who posses two out of these three criteria:\n* Female age ≥40 years\n* Females who have at least one previous cancelled IVF cycle\n* POR according to AFC ≤ 5 or low AMH value.\n\nExclusion Criteria:\n\n* Females over 45 years\n* Females with FSH more than 20 IU/l\n* Females with previous ovarian surgery\n* Females suffering from causes of infertility other than poor ovarian response\n* Females refusing to be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT02338206', 'briefTitle': 'Long Protocol and Growth Hormone in Poor Responders', 'organization': {'class': 'OTHER', 'fullName': "Woman's Health University Hospital, Egypt"}, 'officialTitle': 'Growth Hormone Adjuvant Therapy With Long Down Regulation Protocol in Poor Responders Undergoing In Vitro Fertilization Cycles: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'LP112015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Long + Growth hormone', 'description': 'Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously along with Growth hormone (Norditropin, Novo nordisk) co-treatment daily in a dose of 2.5 mg S.C. till the day of hCG administration.. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG and growth hormone, were continued till the day of hCG administration.', 'interventionNames': ['Drug: Growth hormone']}, {'type': 'NO_INTERVENTION', 'label': 'Long protocol only', 'description': 'Patients in this group were given a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) starting on the day 21 of preceding cycle at a dose of 0.1 mg/day, subcutaneously. On the second day of menstruation, Human menopausal gonadotrophin HMG (75 IU, Merional, IBSA) was started, and this was associated with reduction of triptorelin dose to 0.05 mg/day. This reduced daily dose, in addition to HMG, were continued till the day of hCG administration.'}], 'interventions': [{'name': 'Growth hormone', 'type': 'DRUG', 'otherNames': ['Norditropin, Novo nordisk'], 'armGroupLabels': ['Long + Growth hormone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12211', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr el aini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina M Dakhly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Woman's Health University Hospital, Egypt", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of obstetrics and gynecology', 'investigatorFullName': 'Dina Mohamed Refaat Dakhly', 'investigatorAffiliation': "Woman's Health University Hospital, Egypt"}}}}