Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT02359695
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2015-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose GH Supplementation Increases Clinical Pregnancy Rate
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'}], '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '7 weeks of gestation', 'description': 'Presence of an intrauterine gestational sac with embryonic cardiac activity display, evaluated by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Retrieved oocytes', 'timeFrame': 'On egg retrieval day', 'description': 'Total number of retrieved oocytes'}, {'measure': 'Number of obtained embryos', 'timeFrame': '3 days after egg retrieval', 'description': 'Total number of obtained embryos'}, {'measure': 'Embryo quality', 'timeFrame': '3 days after embryo transfer', 'description': 'Total number of top quality embryos per cycle'}, {'measure': 'Proportion of cycles with embryo transfer', 'timeFrame': '3 days after egg retrieval', 'description': 'Proportion of cycles reaching embryo transfer per initiated cycle'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Poor ovarian response', 'IVF', 'Growth hormone'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess whether a low dose of GH supplementation (0.5 IU/day) increases clinical pregnancy rates in women with a history of POR who failed to become pregnant in two previous IVF cycles.', 'detailedDescription': 'The investigators aim to study the impact of a low-dose growth hormone (GH) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous IVF cycles who failed to achieve pregnancy and were supplemented with low-doses of GH in a subsequent cycle using the same gonadotropin dose and protocol. Our primary endpoint was the clinical pregnancy rate (CPR), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer.\n\nControlled ovarian hyperstimulation will be performed using a GnRH agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the GH supplementation.\n\nAfter confirming pituitary inhibition, the dose of GnRH agonist will be decreased to 0.5 mg/day, and COH will begin with gonadotropins at a dose of 300 UI, subsequently adjusting according to clinical response. Human chorionic gonadotropin (hCG) will be administered when follicles reached \\> 17 mm in diameter. A dose of 0.5 IU of GH will be administered daily from the first day of the agonist until the day of hCG administration. Oocyte retrieval will be performed 36 hours after hCG administration by ultrasound-guided follicle aspiration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with a history of POR, defined according to the Bologna criteria\n* Absence of pregnancy in at least two previous IVF cycles\n\nExclusion Criteria:\n\n* Body mass index ≥ 30 kg/m2\n* Presence of endocrinopathies\n* Altered karyotype in one or both partners\n* History of invasive ovarian surgery\n* History of chronic, autoimmune or metabolic diseases\n* Altered meiosis in testicular biopsy or altered sperm-FISH\n* Drug therapy in the male partner\n* Participation, within the previous 6 months, in another clinical trial with medication'}, 'identificationModule': {'nctId': 'NCT02359695', 'briefTitle': 'Low-dose GH Supplementation Increases Clinical Pregnancy Rate', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Infertilidad y Reproducción Humana'}, 'officialTitle': 'Low-dose Growth Hormone Supplementation Increases Clinical Pregnancy Rate in Poor Responders Undergoing in Vitro Fertilisation.', 'orgStudyIdInfo': {'id': 'CIRH-BROHC-2013'}, 'secondaryIdInfos': [{'id': '2013-003123-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GH cycle', 'description': 'Subsequent IVF cycle, supplemented with a low dose of growth hormone.', 'interventionNames': ['Drug: Growth Hormone']}], 'interventions': [{'name': 'Growth Hormone', 'type': 'DRUG', 'otherNames': ['Somatotropin'], 'description': 'A dose of 0.5 IU of growth hormone will be administered daily from the first day of the agonist until the day of hCG administration', 'armGroupLabels': ['GH cycle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Centro de Infertilidad y Reproducción Humana (CIRH)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Mario Brassesco, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro de Infertilidad y Reproducción Humana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Infertilidad y Reproducción Humana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}